ABSTRACT
This pilot study was designed to evaluate the efficacy and potential benefit of the TESLAR Watch to assist in reducing stress levels in British Members of Parliament working in high stress environments. A total of 25 healthy British Members of Parliament took part. Participants were assigned either a Chipped TESLAR Watch or a placebo over the course of a four-week period. Stress was assessed subjectively by Clinical stress questionnaires and visual analogue scale, and stress resilience by heart rate variability (HRV). Additional measures at pre and post- test were asked on SF8 Health questionnaires. The primary outcomes were efficacy as measured by a reduction of stress levels, improvement of sleep, and an increase of energy.
Despite the lack of statistical significance there were some interesting trends to note.

1. The placebo group showed on average an increase in stress whereas the live group a larger decrease in stress. If this difference in change of approximately 4 units is clinically important then we would need a larger study to detect this with statistical significance.
   
2. The direction of the change in health looks in favour of TESLAR compared with placebo.
   
   
3. The Tension Index in the upright position reduced by 11 on average for the Live group whereas the placebo group showed an increase on average.
   
   
4. There was also a trend towards improvement in sleep in the TESLAR group. This was supported by the observation of several positive comments from MPs in this regard that had been wearing the Live device but not from those that were wearing placebos. The significance of this result was compromised by 65% of MPs not reporting any sleep disturbance at the outset. It is likely that this trend may prove significant in a larger study.

The results of this pilot study are of sufficient interest and potential importance to now lead us to conduct a larger study.

SPONSORS
Success By Association, Inc (SBA)

STUDY SITE
Houses of Parliament, London, UK

PRIMARY OBJECTIVE
Determine the efficacy of the TESLAR watch to improve stress, sleep, and energy of British Members of Parliament in a high stress environment, in comparison with sham watch.

INTRODUCTION

Stress is one of the leading causes for absenteeism in the workplace in the UK. According to the Health and Safety Commission (HSC) and Health and Safety Executive (HSE), who are responsible for the regulation of almost all the risks to health and safety arising from work activity in Britain, stress is a major case of disease in the workplace. The following bullet points summarize the latest studies done in the UK to determine the severity of this preventable disease.

• The 2003/4 survey of Self-reported Work-related Illness (SWI03/04) prevalence estimate indicated that over half a million individuals in Britain believed in 2003/4 that they were experiencing work-related stress at a level that was making them ill. The Stress and Health at Work Study (SHAW) indicated that nearly 1 in 5 of all working individuals thought their job was very or extremely stressful.
  
  
• Estimates from SWI03/04 indicate that self-reported work-related stress, depression or anxiety account for an estimated thirteen million reported lost working days per year in Britain.
  
  
• Survey data suggest that the incidence of work-related stress and related disorders in the British population was unchanged between 2001/2 and 2003/4 although there is evidence of a rise in incidence from 1995 to 2001/02. The latest years of THOR surveillance data indicated a fall in cases of work-related mental ill-health. Overall this suggests that the incidence of work stress is no longer rising in Britain. However, interpretation of these data are complex and imprecise, and more years of data are required to properly assess trends.
  
  
• Occupation and industry groups containing teachers and nurses, along with protective service occupations and some managerial groups have high prevalence rates of workrelated stress in the SWI and SHAW surveys. The THOR datasets SOSMI and OPRA also report high incident rates of work-related mental illness for these occupational groups, along with other public sector workers such as police officers, social workers, prison officers, UK armed forces personnel, medical practitioners and those related administrative or managerial roles. Although based on smaller case numbers train drivers and telephonists also had relatively high rates of work-related mental ill-health in THOR data.

Presently, the conventional approach towards stress is minimal. Most workplace environments use the standard approach of education and awareness such as the HSEs case study of Somerset County Council. The organization, Somerset County Council, used the following components as their interventions to combat stress:
Listeners Service, Training documents for Managers to identify and assist coping with stress, Comprehensive 2 day training course, Comprehensive 21 page document, Counseling Services, Awareness Training Day Program, and Presentations and pamphlets. This program cost the County more than £100,000 to implement with regards to design, implementation, monitoring, and documenting results.

Although awareness and education on managing stress are important for those working in high stress environments, at times the interventions can be time-consuming and costly.

Aside from work related pressures, stress also originates from different sources: lifestyle, family, work, etc. Not often considered as sources of stress are environmental pollutants related to our daily use of modern devices that can lead to increasing stress in the body. Less than 75 years ago, we did not have cell phones, computers or live near high-tension wires and our bodies were in balance with the earth's natural frequencies. Today, electronic pollution has increased multifold as we have increased our usage of television, radio, cellphones and other electronic gadgets. As a result of this drastic and relatively sudden increase, scientists worldwide have been routinely demonstrating, since the 1970's and still today, the resulting harmful biological effects on the human species. Today, a technology exists that can assist employees without timeconsuming workshops or presentations to be more productive in the workplace. This technology has been used in the TESLAR watch for 20 years and helps address these harmful environmental pollutants by assisting the body to fortify its own biofield (electromagnetic field), resulting in wearers noticing they are generally calmer and less tense when using the technology.

BACKGROUND: TESLAR WATCH

For the past 25 years, scientists have been gathering data showing that exposure to electromagnetic frequencies (EMF) may have non-thermal biological effects on the human body. In 1979, Johns Hopkins University published a study in the American Journal of Epidemiology indicated that homes of children who developed cancer were often found near high-tension electric power lines (Wertheimer and Leeper).

Following this landmark study, many statistical and laboratory studies showed links between EMF and disease and actual biological effects of EMF. Some of these studies have been published in scientific journals such as the American Journal of Epidemiology, Nature, American Journal of Industrial Medicine, and Carcinogenesis, to name a few. In 1989, scientists reported to the US Congress on these studies and the biological effects of EMF from power transmission lines (Nair, Morgan, Florig). Only recently have local governments in countries like Spain and France begun enacting legislation outlawing cell-phone relay towers near schools and apartment buildings due to strong public demands. Some countries, like Switzerland and parts of Italy, have already adopted precautionary exposure limits to EMF.

Yet in most countries, scientific and political communities continue only to debate whether EMF even affects the human body (non-thermally), despite 25 years of research warning of EMFs danger. Like tobacco, for many years the official position was There is no clear link to disease, but smoking MAY be harmful to health¯; the de facto U.S. government response to EMF has become, There is no clear link to disease, but you MAY want to limit your exposure.

In 1976, Dr. Andrija Puharich became interested in the biological effects of EMF when Aviation Week & Space Technology reported on strange radio signals coming from the USSR, to which the US Government was protesting. Concerned about the possible biological effects intended with that signal, Puharich began research into the biological effects of ELF. Around the same time, Ilonka Harezi was researching bio-electromagnetic phenomena and its influence on the body and mind with Dr. Patrick Flanagan, PhD. Her research brought her into the realm of energy, resonance, and the mobius coil.

In 1984, Dr. Andrija Puharich and Ilonka Harezi joined forces. Rather than focusing on the possible deleterious effects of EMF or ELF, Puharich and Harezi chose to look at whether there could be beneficial effects of ELF on the body and whether it was possible to prevent or reduce the harmful ELF from interacting with the physical body.

Together, Dr. Puharich and Ms. Harezi studied the works of Nikola Tesla, who, in addition to inventing Alternating Current (AC) electricity, performed extensive research into coils, resonance, standing-wave/scalar fields and free energy. They also researched the possibility of bathing the body in the frequency environment emitted naturally by the earth, the Schumann Resonance (currently monitored by scientists at UC-Berkeleys Seismology Laboratory to average around 7.83 Hertz) to assist in reducing the adverse effects of EMF.

Over the past 50 years, society has seen an increase of technological advancements which have increased our exposure to hazardous EMF. Hence, Dr. Puharich and Ms. Harezis focus was to reestablish the natural frequency envelope around the body - by blocking out or reducing the effects of this increasingly chaotic invasion of man-made EMF. The resuts provided the human body an opportunity to reestablish its own natural electromagnetic environment. They also hypothesized that bathing the body inside this earth signal would provide a steady, calming frequency in the Theta/Alpha brainwave region, normally associated with relaxation and creativity, meditation and prayer.

Combining their own experience and knowledge with Nikola Teslas standing-wave theories, Dr. Puharich and Ms. Harezi developed an early prototype of the TESLAR technology in 1985. Using a special coil wound inside a battery-powered bracelet, preliminary results were promising. However, the design needed improvement so Ms. Harezi set out to develop a process whereby the coil would fit onto a smaller, more flat surface. She succeeded with the TESLAR chip.

In 1986, Ms. Harezi and Dr. Puharich placed the TESLAR chip inside a standard wristwatch.. Confirmed by early studies, TESLAR technology reinforced the human bodys own electromagnetic field, 24-hours a day.

Functional Description

The TESLAR technology has been designed to emit a unique 7 to 9 Hz Alpha wave-like signal that interacts with and strengthens the bodys own electromagnetic energy field. Similar to the Earths natural 7.8 Hz signal and the Alpha wave signals emitted by the brain when the body is calm or meditating or when athletes are in states of high performance, this TESLAR signal was also designed to help reinforce the bodys energy field against the possible negative effects of external, low-energy electromagnetic fields (EMF).

In a TESLAR watch there are two specially designed TESLAR chips. This technology works with the watchs standard components:

1. The watch battery, which creates an electric field
2. The quartz-crystal timing coil, which creates a magnetic field

The TESLAR chips interact with these two fields to create a resonant circuit which produces a zero-point (scalar) waveform. Modulated on this scalar waveform, the TESLAR chip sends a 7 to 9 hertz frequency into and around the body via the left arm's triple warmer meridian (energy conduit). The TESLAR watch is an active device and it oscillates around the earths natural Schumann Resonance frequency. The TESLAR technologys frequent oscillation allows the signal to stay energetically interactive, which is important because the body can acclimate to stimuli that stay constant for any given period of time.

The TESLAR technology works via the triple warmer meridian. The triple warmer meridian is one of the body's primary energy conduits. Dr. Charles Shang, M.D. in Internal Medicine, describes the bodys meridian system as a measurable, distinct signal communication system which overlaps and interacts with other systems but is not simply part of the nervous system or circulatory system.¯ Dr. Shang also states that estimulation of the meridian system may activate the self-organizing system of an organism and improve its structure and function at a more fundamental level than symptomatic relief.¯

The triple warmer meridian starts at the 4th finger (from the thumb) and travels up the arm, through the shoulder, behind the ear and finally to the corner of the eye. It is the energy conduit has ben known to activate the immune system.

This meridian enables the TESLAR technology's signal to be carried throughout the body. This process bolsters the body's naturally occurring electromagnetic field the biofield - working much like a protective shield. Dr. Valerie Hunt, UCLA Prof Emeritus, describes the TESLAR technology as helping to create a biofield with more coherency, strength, and greater breadth of frequency.

Figure 1 TESLAR watch

Technical Specifications:

The TESLAR technology works with a commercially available wristwatch movement. The measurable energy emitted from the watch is primarily due to the watch movement and battery. The TESLAR technology does not emit electromagnetic energy above the ambient noise of the environment, as measured by Underwriters Laboratory (Product Safety Testing) in 2002.

Mechanism of Action

TESLAR watches contain a non-Hertzian signal-producing chip. The non-Hertzian, scalar chip functions as described in Block Diagram (see Figure 2).

In a paper on Scalar Energy, Glen Rein, Ph.D. states that, "biological systems are sensitive to non-hertzian energy..." Although such energy has not been measured in the body and is not being considered by the bio-medical community (they barely recognize a functional role for conventional EM fields), it is likely to be involved in biological processes since quantum mechanical analysis of biological systems has recently indicated their inherent nonlinearality.

Figure 2 Block Diagram

When understood, we will find that practitioners such as Reiki and CranioSacral types are not sending specific frequencies, such as for liver repair or stomach repair, but ONE basic nonhertzian PE-charge that "systemically" ignites each and every B-cell. Otherwise, it is like the analogy of towing a broken car and expecting the tow to fix it.

The non-hertzian PE-charge relieves the body of stress. Peter Kelly of Dimensional Science states, "It is well known that physical stress hampers the body's immune system. Therefore, the release of stress, particularly chronic stress, can have beneficial effects by enabling the body to relax and recover the normal level of its own natural and vital immune and healing qualities."

The Quantum Piezoelectric Force (QPF) states that "rhythmic percussion generates a nonhertzian PE-charge that systemically ignites every cell."

POTENTIAL BENEFITS:
The theory of TESLAR shielding is that it transforms harmful ELF signals and provides an enhanced body electric pathway for the harmful frequencies to use in bypassing the body's nervous system. The TESLAR uses subtle energy technology to screen the body from potentially harmful electronic pollution caused by the abundance of machines, electronic gadgetry, and power lines, in a way that allows the body to operate more harmoniously within the earth's natural resonance field.

POTENTIAL RISKS:
The TESLAR watch is environmentally friendly, non-invasive without reported adverse effects, but with the possibity of discomfort depending on individuals sensitivity. The rubber material of the bracelet may cause irritation to the skin in individuals with allergies.

SAFETY
In September 2002, Underwriters Laboratory (UL) International EMC Services in Northbrook, IL, measured two quartz movement watches provided by ELF Laboratories, original manufacturer and supplier of TESLAR technology since 1986. One watch included TESLAR technology while the other watch, identical in style and material, did not include TESLAR technology. The watches were tested in a fully anechoic chamber to allow for minute electromagnetic field measurements.

UL EMC Services found no significant electromagnetic field (10 KHz to 30 MHz) for either watch above the noise floor of the measurement system. Using a magnetic field meter, they found a difference in magnetic field strength for the watch incorporating TESLAR technology, yet both watches were still below typical ambient magnetic field strengths, as defined by UL EMC Services.

UL found no electromagnetic field strengths above typical environment levels in either the quartz watch incorporating TESLAR technology or the quartz watch without TESLAR technology. Based on that finding, there is no indication quartz watches incorporating TESLAR technology should present an increased safety risk to the wearer beyond that of standard quartz wrist watches.

RESEARCH

Researchers began independent testing on the original TESLAR watch in 1988. In an independent pilot study done in 1989, Dr. Eldon Byrd, PhD, former U.S. Navy scientist for the investigation and research of the biological effects of ELF, observed a decrease in overall frequency amplitude and a shift toward lower frequencies in EEG recordings from individuals wearing the TESLAR watch. This pilot study demonstrated that the brain throws off 80% of the assaulting ELF with the help of the TESLAR.

Other studies have used Electro-dermal Screening (EDS). Electro-dermal screening was developed 35 years ago by Dr. Reinhold Voll, M.D., who combined the principles of acupuncture with modern technology. Each individual structure in the body has its own electromagnetic field. According to EDS, the strength of this electromagnetic field can be measured at identified acupuncture points, each point having a direct relationship to a specific organ. Using sensitive instruments, one can measure the electromagnetic potential at each point and thus draw a conclusion as to the electrical balance of the inner organs.

Using EDS in 1991, Dr. Anthony Scott-Morley, PhD, M.D., tested a variety of devices claiming to protect the subject from various environmental stresses. While testing an early version of the analog TESLAR watch, Dr. Scott-Morley showed the presence of the watch enabled the body to screen out or block ambient signals within our environment and those produced by generators and computer terminals. Testing the TESLAR on many of his patients, he recorded dramatic improvements in the energy level readings of most organs. Wolde Korol, Diplomat of Acupuncture, replicated Dr. Scott-Morleys findings in 1992.

Dr. Glen Rein, PhD, while at Stanford Medical School, conducted in-vitro research using the TESLAR watch. Dr. Reins results showed that the presence of the TESLAR watch provided an environment in which there was, on average, 137% enhancement of human lymphocyte proliferation (immune function). Another test demonstrated that nerve cells could inhibit their uptake of noradrenalin (a depression-fighting process) by as much as 19.5% in the presence of the TESLAR watch.

In June, 2002, the results of a pilot Heart-Rate Variability (HRV) study conducted by Dr. Michael Borkin, N.D., appeared in Alternative Medicine Magazine demonstrating the TESLAR watchs positive influence in the presence of a cell phone. HRV is the measurement of the beat-to-beat changes in heart rate, giving a dynamic glimpse into the autonomic nervous system (ANS) state. This system controls the beating of the heart, the movement of the gastrointestinal tract and the secretion of hormones by the endocrine glands, among other vital functions. Thus, an HRV test is a good measurement of a bodys overall response to stimuli.17 Dr. Borkin stated that his HRV study showed that the use of the TESLAR watch may in fact compensate for some of the negative impact of using a cell phone.ā€¯

In 2003, British Medical Doctor, Nyjon Eccles, Member of the Royal College of Physicians, saw similar results on patients. Dr. Eccles HRV testing confirmed that without the TESLAR watch, the autonomic nervous system becomes stressed when exposed to an energized mobile phone. While wearing the TESLAR watch in the presence of an energized cell phone, Dr. Eccles results revealed a estabilizing effectā€¯ on or even beneficial stimulation¯ of parasympathetic regulatory system activity.

Dr. Valerie Hunt, professor emeritus of UCLA and founder of the BioEnergy Fields Foundation, has performed extensive research on the human bodys electromagnetic field. Dr. Hunts experience with the TESLAR technology has led her to conclude that wearing the TESLAR watch makes the [biofield] more dynamic and coherent, so that its transactions with the world are not just reactionary, but also selective.¯

In 2004, laboratory studies led by physicist, Dr. Volodymyr Krasnoholovets at the National Institute of Physics in Kiev, Ukraine, investigators discovered that effects of the TESLAR technology can be measured using various water-based solutions (including blood plasma). Specifically, in a series of 5 studies, exposure to TESLAR technology was shown to have some affect on (1) the polarization and alignment of water molecules and thus their electrical characteristics; (2) certain electromagnetic frequencies traveling through blood plasma solution; (3) internal vibrational dynamics of certain crystals; (4) rates of molecular vibration at particular frequencies under certain conditions; and (5) the crystal formation of an oxygen-saturated amino acid solution. The in-vivo implications of these results is the subject of further research.

METHODS

The study population consisted of 25 British Members of Parliament (MP) who had been identified as healthy MPs working in a high stress environment and meeting the inclusion and exclusion criteria detailed below.

Before being selected, the British Members of Parliament were provided with an outline of the study and requested to voluntarily sign the informed consent.

INCLUSION CRITERIA

• Participants were18 years or older
• Healthy individuals
• Working in high-stressed environment
• Difficulty sleeping or other symptoms related to high stress
• Be willing to sign an Informed Consent

EXCLUSION CRITERIA

• Low stress lifestyle and workplace, no stress
• Clinically diagnosed and taking medications for depression, sleep or anxiety (Paxel, Prozac, Zoloft, sleeping pills, (See Appendix I)
• Clinically diagnosed with cardiovascular problems
• Clinically diagnosed with diabetes
• Pregnant or attempting to be pregnant during the month while participating
• Simultaneous participation or participation in another study in the last 30 days
• Wearing an electrical device such as a pace maker
• Traveling/ unavailable from enrollment of study through the month
• Unwilling to sign informed consent

TREATMENT PROTOCOL

Experimental group
All participants received a watch and were instructed to wear it 24 hours a day for 1 month (except for during bathing or showering).

They were not informed whether they were receiving a Live or a placebo device. In this respect the Study was conducted single blind.

COMPLIANCE TO TREATMENT

Interruption or discontinuation of using TESLAR watch
An interruption or discontinuation of the use the TESLAR watch occured for the patients

1. whose sensitivity was so great that the participant was unable to wear the watch 24 hours/day
2. who did not comply to treatment or were difficult to locate
3. who did not wear the watch 24 hours a day

Participants who discontinued using the watch after initiation of the study were not replaced. If a participant discontinued wearing the watch or the participant discontinued his/her participation, their information was still collected and analyzed as secondary information, if this was at all possble.

Any additional changes in activity of of the participants, e.g. addition of a medication or anyother lifestyle changes were documented. Participants were visited twice for observation (baseline, Day 30 for termination) with a midpoint check in, to document any adverse effects and whether there had been compliance with the study protocol.

DATA COLLECTION

Baseline Data

Basic demographic data, medical history, and concomitant medications were collected following informed consent into the study. Questionnaires include the SF-8 (Quality of Life measurement) and the Perceived Stress Scale 10. In addition 2 further questions were incorporated on a visual analogue scale basis to assess quality of sleep and subjective stress levels.

Quality of Life

The SF-8 Health Survey was selected for use as a general functional health status (FHS) questionnaire because it is reliable, valid, and takes only one or two minutes to administer. The SF-8 uses a single question to capture each of the eight health domains originally validated in the widely-used functional health status measurement tool the SF-36. The eight domains are physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, emotional well-being, energy/fatigue, pain, general health perception and health change. An example of the SF-8 can be found in appendix II. The SF-8 served as a secondary outcome measure and will be administered at baseline and at the one month termination.

Perceived Stress Measures

The instrument used most often is the Perceived Stress Scale (PSS; Cohen, Kamarck & Mermelstein,1983; Cohen & Williamson, 1988). The PSS is a measure of the degree to which situations in ones life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. There are three versions of the scale, with 4-items, 10-items, or 14-items. The 10-item vers was used since it is thought to have maximum reliability, although the 4-item vers can be used for telephone interviews and situations where the number of items is critical. This scale assessed the amount of stress in ones life rather than in response to a specific stressor and has been used widely in studies of both mental and physical health.

Heart Rate Variability

Based on Heart Rate Variability (HRV) analysis, Nerve-Express is a fully automatic, noninvasive computer-based system designed for quantitative assessment of the Autonomic Nervous System (ANS). HRV analysis is based on measuring variability in heart rate; specifically, variability in intervals between R waves - RR interval¯. These RR intervals are then analyzed by spectral (as in Nerve-Express) or some other form of mathematical analysis (e.g., chaos, wavelet theories). Such mathematical analysis generates multiple parameters; typically 20-30. The problem of Sympathetic Nervous System (SNS)- Parasympathetic Nervous System (PSNS) quantification, which has remained for many years the principal dilemma of HRV analysis, is specifically in reducing all possible variations of these multiple parameters to a quantitative relationship between only two parameters: the SNS and the PSNS. Nerve-Express focuses on solving the problem of SNS-PSNS quantification. This is achieved by using algorithms and a new approach based on one of the leading theories of Artificial Intelligence - Marvin Minsky's Frame Theory. Nerve-Express objectively and reliably evaluates the state of ANS in "real-time" (up to 24 hours) as well as during Orthostatic test and Valsalva maneuver combined with Deep Breathing. Due to its highly sophisticated HRV analysis, Nerve-Express results uses precise recognition and classification of 74 ANS states with a corresponding qualitative description for each one.

CRITERIUM OF EVALUATION

1. Clinical History
2. Quality of Life: Quality of Life (SF 8)
3. Clinical Stress Evaluation: Stress Response Inventory and VAS
4. Heart Rate Variability

PATIENT PROGRESSION

The evaluations would occur:

1. At the moment of entering the study:
   
   1. Clinical History
   2. Quality of Life: Quality of Life (SF 8)
   3. Clinical Stress Evaluation: Stress Response Inventory
   4. Subjective Stress Test: Visual Analogue Scale
   5. Heart Rate Variability
      
      
2. At the 15 day after using the watch
   
   1. Check in
   2. Telephone interview with Personal Assistant
      
      
3. At the 30 day after using the watch/ Termination Date:
   
   1. Lifestyle change checklist
   2. Quality of Life: Quality of Life (SF 8)
   3. Clinical Stress Evaluation: Stress Response Inventory
   4. Subjective Stress Test: Visual Analogue Scale
   5. Heart Rate Variability

Safety: The evaluation of safety was based on the monitoring and the registration of all adverse events recorded on a monthly basis through termination date. Any adverse events was communicated by the participant and recorded at the questioning period by the investigator, collected and registered in the Case Report Form Adverse Events and followed in the appropriate manner by research staff. A non-serious adverse event was deemed to be a sign, symptom or undesirable illness that occured after the initiation of the administration of the treatment, even though the event is not related to the treatment. A serious adverse event was defined as pregnancy during the study, overnight hospitalization, or death. In any case, all adverse events were recorded on the Case Report forms. (See Appendix III: Definitions and Procedures).

Note: Any information collected on participants that discontinued due to adverse events or drop out was still used for secondary endpoint analysis as deemed by the biostatician.

STUDY PLAN

	Pre-X	Day 15	Day 30/ Termination Date
Clinical History/ Lifestyle change	x		x
Clinical Stress Evaluation: Stress Inventory Response	x		x
QoL SF8	x		x
Subjective Stress Test: Visual Analogue Scale	x		x
Heart Rate Variablity	x		x
Check In		x

DATA MANAGEMENT

The data collection forms were developed by SBA staff, in collaboration with Dr. Nyjon Eccles. The data were collected on these forms by Dr. Eccles and his research staff and stored in locked file cabinets according to Data Protection Act (DPA) standards.

Information about study subjects was kept confidential.

All subjects for this study were provided with a consent form describing this study and providing sufficient information for subjects to make an informed decision about their participation in this study. See Appendix I for a copy of the Subject Informed Consent Form.

STATISTICAL METHODS

All outcome measures are summarised using median (interquartile range) (IQR). The change (month1 baseline) in each outcome measure was calculated for each subject. The changes were compared between groups (placebo / live) using the Mann-Whitney test. Note that a statistical test to evaluate whether the two groups were different at baseline was not undertaken because the change from baseline the primary analysis.

The sample size is 25 and reflects a pilot study only to observe any possible benefits and the safey of the TESLAR watch.

FUNDING SOURCE

This study was financed through a grant from the manufacturers of the TESLAR technology, Success By Association.

CONFLICT OF INTEREST

There were no conflicts of interest and all data was analysed by a third party statistician who also had no vested interested in the outcome of the study.

SUBJECT STIPENDS OR PAYMENTS

All participants at the completion of the study were allowed to keep their TESLAR watch/ bracelet in compensation for participating and those that had received a placebo were informed of this at the completion of the study and given a Live TESLAR watch to keep. No monetary compensation was provided.

ETHICAL APPROVAL

The East London and the City Research Ethics Committee has been sent all the necessary documentation and their decision is still awaited.

RESULTS

The Live TESLAR group was comprised of 16 paticipants, 14 males and 2 females, average age 48.6± 10.95 (Mean ± SD). The placebo group comprised 9 participants, 8 males and 1 female, average age 46.6 ± 10.1.
Twenty-five subjects entered the study of which 9 were allocated to placebo. Some participants did not have all outcome measures at all time points so a change could not be calculated. For all outcome measures except VAS changes could be calculated for 22 subjects (7 in placebo group). For VAS the calculations could be completed on 6 from the placebo group and 14 from the Live group. One subject, a male MP in the Live group discontinued the study stating that wearing the device at night disturbed his sleep. We do not have sufficient information to clarify whether this was due to its physical presence or whether this represented another effect of the watch. Hos results were therefore excluded from the primary outcome analysis.

The results are presented in tables 1a and 1b, with the heart rate variability data in Table 1b. Table 2 shows analysis of the key HRV parameters measured in the supine and upright positon. The purpose of this amalysis was to look for any potential changes in response of the autonomic nervous system to challenge that might be explained by the treatment. Baseline values are reported as well as the change from baseline at 1 month. Thus a negative value indicates a reduction in the measure of interest.

Table 1a. Statistical analysis of Questionnaire data

Outcome measure		Group		p-value for difference in change
		Placebo	TESLAR
Health	baseline change	5.0 (2.0,11) -2.0(-2.0,0.0)	5.0 (3.0,9.0) 0.0 (-2.0,1.0)	0.298
Pain	baseline change	1.0 (0.0,2.0) 0.0 (-1.0, 0.0)	1.0 (0.0, 1.0) 0.0 (0.0, 1.0)	0.162
Sleep	baseline change	1.0 (0.0,2.0) 0.0 (-1.0, 0.0)	1.0 (1.0,2.0) 0.0 (-1.0, 0.0)	0.783
Stress	baseline change	11 (8.0, 15) 1.0 (-5.0, 5.0)	13 (12, 18) -3.0 (-7.0,0.0)	0.210
VAS (subjective stress)	baseline change	4.0 (2.9, 5.3) 0.0 (-1.0, 2.3)	5.3 (3.6, 6.1) -1.0 (-2.0, 0.5)	0.274

Table 1b. Statistical analysis of HRV data (see also Table 2)

Outcome measure		Group		p-value for difference in change
		Placebo	TESLAR
SDNNS	baseline change	34 (24, 58) 7 (-14, 27)	44 (33, 59) -3(-17, 7)	0.267
SDNNU	baseline change	39 (13, 54) 9 (-6, 21)	48 (32, 52) -3 (-4, 5)	0.407
TI_S	baseline change	149 (78, 228) 29 (-127, 102)	115 (70, 222) 24 (-18, 72)	0.731
TI_U	baseline change	114 (86, 493) 4.0(-439, 45)	166 (89, 229) -11 (-35, 35)	0.581
HRV	baseline change	5.0 (4.0, 7.0) 0.0 (0.0, 1.0)	5.0 (4.0, 7.0) 0.0 (-2.0, 1.0)	0.490
TP_S	baseline change	338 (152,1153) 335(-586, 588)	836(426, 1829) -283(-846, 287)	0.237
TP_U	baseline change	733 (72,1108) 178 (-31, 362)	738 (327,1048) 141(-86, 627)	0.891
H/L_S	baseline change	0.39(0.18,1.1) 0.13(-0.29,0.24)	0.33(0.21,0.59) 0.07(-0.12,0.51)	0.581
H/L_U	baseline change	0.12(0.08,0.29) 0.06 (-0.02, 0.16)	0.25(0.18,0.39) -0.01(-0.19,0.18)	0.298

Table 2. Analysis of HRV differences in the upright compared with the supine position

Outcome measure		Group		p-value for difference in change
		Placebo	TESLAR
SDNN_USdiff	baseline change	1.0 (-11, 14) -4.0(-20, 16)	-1.0(-13,8.0) -1.0(-8.0,38)	0.581
TI_USdiff	baseline change	8.0(-131, 365) 49(-280,172)	18 (-13, 8.0) -9 (-57,39)	0.535
TP_USdiff	baseline change	-3.0(-157,830) -41(-577,555)	-154 (-1091,96) 235(-373,2191)	0.267
HL_USdiff	baseline change	-0.33(-0.78,0.11) 0.26(-0.23,0.74)	-0.10(-0.25,-0.04) -0.01(-0.20,0.28)	0.298

Example:

TI_USdiff
Baseline value is TI in upright TI in supine: TI_U1-TI_S1
So, the change is (TI_U2-TI_S2) (TI_U1-TI_S1)

If change is negative then the difference between Upright and Supine values is smaller at 1 month than at baseline.

Calculations for SF8 scores

A mean score was calculated for each subject, before and after (called scoreA and scoreB). The change in score was then calculated for each subject and compared with the changes between groups using a Mann Whitney test.

Results

The change in score was available for 6 subjects in the placebo group and 14 in the live group. For those 6 and 14 subjects the mean (sd) score before treatment (Score A) was 53.1 (2.4) and 52.4 (3.0) respectively. The mean (sd) score after treatment (score B) was 54.2(2.9) and 51.9(3.0) for the placebo and live groups respectively. The median (IQR) change in scores was 0.69(-0.06, 2.05) and 0.00(-1.00, 0.96) for the placebo and live groups respectively. The difference in change between the groups was not statistically significant (p=0.153).

DISCUSSION

Both groups were well matched for age although there was a male dominance in volunteers for the study.

One can see from the tables that no differences reached statistical significance, but this is not unexpected in a small study. Unfortunately, not all the data could be analysed by the statistician and this led to a reduction in data in an already small study. However, one must bear in mind the pilot nature of the study and as noted below there are sufficient interesting trends tro warrant progress to a larger study.

Our statistician has computed that using the results in table 1a for the changes in stress, a difference of 3.5 units between the groups would be detected with at least 50 participants completing the study in each group. This was based on 5% significance level and 80% power. No statistically significant differences were observed in the Health SF8 scores.

Despite the lack if statistical significance there are some interesting trends to note.

1. Firstly, the placebo group showed on average an increase in stress whereas the live group a larger decrease in stress. If this difference in change of approximately 4 units is clinically important then we would need a larger study to detect this with statistical significance.
   
   
2. The direction of the change in health looks in favour of TESLAR compared with placebo.
   
   
3. The Tension Index in the upright position reduced by 11 on average for the Live group whereas the placebo group showed an increase on average.
   
   
4. There was also a trend towards improvement in sleep in the TESLAR group. This was supported by the observation of several positive comments from MPs in this regard that had been wearing the Live device but not from those that were wearing placebos. The significance of this result was compromised by 65% of MPs not reporting any sleep disturbance at the outset. It is likely that this trend may prove significant in a larger study.

The Tension Index increases when there is less variability in the ANS and reduces when there is more flexibility in the ANS. The trend in differences in the Tension Index are interesting and consistent with those described previously (Eccles, 2003; Wasl, 2003) that demonstrate a greater ANS total power especially in the face of challenge after wearing the TESLAR watch. This may suggest an ability of the watch to stimulate the parasympathetic component of the ANS.

The results of this pilot study are of sufficient interest and potential importance to now lead us to conduct a larger study.