Socio Behavioral Pilot Study To Determine The Effect Of TESLAR Watch In Healthy Volunteers With Non Restorative Sleep

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PROTOCOL DRAFT
Protocol # 001145
Date: September 27, 2007

ABSTRACT

This socio-behavioral pilot study will evaluate the potential benefits of the TESLAR watch on healthy volunteers with non-restorative sleep. A total of ten (10) healthy volunteers will participate by using the TESLAR watch over the course of one week period. Five (5) healthy volunteers will initially be enrolled and at completion an interim analysis will be done to determine if another 5 volunteers should be enrolled. Assessment will include clinical sleep quality questionnaires, Polysonographic testing, and diary. Additional measures at pre and post test will include medical history, sleep history, pregnancy screen, and basic clinical evaluation. The primary outcome is evaluating the potential benefits and socio-behavioral changes in restoring non-restorative sleep for healthy volunteers using the TESLAR watch.

INVESTIGATORS Fabriccio Lettelier, MD

SPONSORS TESLAR Inside Corporation (TIC)

STUDY SITE Sleep Disorder Solutions, Inc Miami, FL

INTRODUCTION

This document is a protocol for a human research study. This study is to be conducted according to federal standards of Good Clinical Practice (FDA Title 21 part 50), applicable government regulations and international research policies and procedures (Helsinki Declaration).

BURDEN OF DISEASE

In the modern industrialized society many people have severe sleeping problems or a lack of restorative sleep. Instead of feeling refreshed upon awakening they complain about tiredness, lack of concentration, irritability and negative influences of their working performances although they had enough sleeping time.

Non-restorative sleep is associated with daytime impairment (irritability, physical and mental fatigue) and deterioration of performance. Historically, nonrestorative sleep appeared as an insomnia symptom in the DSM-III-R of the American Psychiatric Association in 1987 Since then, there has been various epidemiological studies and clinical studies. However, NRS has been associated with obesity , cardiovascular disease, chronic fatigue syndrome and fibromyalgia. Also as previously mentioned, NSR is a symptom for insomnia, restless leg syndrome, and periodic limb movement disorder. In western industrial nations, approximately 15 - 35% of the populations suffer from light to heavy sleep disorders, which are known to cause severe discomfort and even cardiovascular health risks. A significant number of those suffering from non- restorative sleep are not properly diagnosed; in the U.S. alone 10% of the roughly 10 - 20 million affected people do not receive medical attention. Dr. Ohayon study of 25580 individuals in 7 European countries showed that the prevalence of NSR was 10.8%; thereby having increased societal costs with regards to decreased productivity and diminished quality of life. Presently, the conventional approach towards nonrestorative sleep is evaluating different causes such as circadian rhythm disturbances, psychiatric or organic causes, sleep hygiene, and or intake of sleep disturbing substances. Addressing these underlying causes may be difficult as times as many people do not recognize the causes of nonrestorative sleep.

Awareness and education on managing nonrestorative sleep are the most common ways of addressing the issues associated with nonrestorative sleep as its effects can be detrimental to daytime performance.

Recently testimonials from wearers of the TESLAR watch have reported that feeling better in the morning or having slept better. The TESLAR Technology has been used for the last 20 years to assist the body in fortifying its own biofield, resulting in wearers being calmer and less tense.

It is the purpose of this preliminary socio-behavioral, pilot study to further explore the effects of wearing the TESLAR watch, on healthy volunteers with nonrestorative sleep.