A Double-Blind Placebo-Controlled Multi-Site Randomized Cross-Over Study of the Feasibility, Effectiveness and Efficacy of the PowerSleep Device

Detailed Summary

The purpose of this study is test the effectiveness of the PowerSleep auditory stimulation device on sleep quality and daytime functioning in individuals who have insufficient sleep. The PowerSleep device is a non-invasive portable device designed to increase deep sleep, potentially reducing daytime sleepiness related to insufficient sleep. The device is meant to be worn while a person is sleeping. The device delivers soft audio tones (below 65dB (decibels)/ normal speaking voice) via headphones periodically throughout the night and records the electrical activity of the brain (electroencephalogram (EEG)). The device consists of a headband with 4 sensors on the forehead, one sensor behind the right ear, headphones covered by speaker foam over each ear, and a cable which connects the headband to an upper arm band. The armband contains the device electronics. The headband and the armband are connected via adjustable Velcro closure. This device has not been released for sale and is considered investigational. The study includes approximately 30 people from four study sites. It is anticipated that a total of up to 10 people will complete the study at this site. This study is designed to last up to 6 weeks.

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