A Study of the Effectiveness and Efficacy of the PowerSleep Device

Exclusion Criteria

• •Participation in another interventional study in the past 30 days.
• •Previously enrolled in a PowerSleep study.
• •Major controlled\* or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, Chronic Obstructive Pulmonary Disease (COPD), respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report and reviewed by the study PI.)
• •Currently working night, swing, split or rotating shift.
• •Current use or use of within the past month of a prescription or over-the-counter sleep medication or stimulant; use of psychoactive medication (based on self-report and review with a study clinician). Refer to table below for examples.
• •Pregnant or currently breast feeding
• •Current Smokers or using nicotine replacement therapy. Those that have been nicotine free for 30 days will be included.
• •Body Mass Index \> 40 kg/m2
• •Prior diagnosis of any sleep disorder including
• •1. Obstructive Sleep Apnea (AHI ≥15 events/hour) - from ambulatory or in lab polysomnography
• •2. Restless legs syndrome, or periodic limb movement disorder
• •3. Insomnia
• •4. Parasomnia
• •High Risk of Obstructive Sleep Apnea (OSA) based on STOP-BANG Questionnaire ("yes" on at least 4 of 8 questions)
• •High Risk of Restless Legs Syndrome (RLS) based on Cambridge-Hopkins Screening questionnaire
• •High Risk of Insomnia based on Insomnia Severity Index (score of 22 or higher)
• •Self-reported history of excessive alcohol intake- self-report \> 21 drinks / wk or binge alcohol consumption ( \>5 drinks per day)
• •Excessive caffeine consumption (\> 650mg/day combining all caffeinated drinks regularly absorbed during workdays.) Caffeine intake must be regular and maintained throughout study and on testing days
• •Individuals who self-report a history of recurrent seizures or epilepsy or have a history of medical conditions that could increase the chance of seizures (e.g. stroke, aneurysm, brain surgery, structural brain lesion).
• •Individuals who self-report severe contact dermatitis or allergy to silicone, nickel or silver.
• •Individuals who self-report moderate hearing loss.
• •Inability to achieve appropriate headband fit.
• •Planned travel across more than one time zone one month prior to and or during the anticipated period of the study with PowerSleep device use
• •Intentional naps during the work week.
• •Alpha-Delta waveforms as determined by Baseline night PowerSleep Device data collection
• •* Participants who are on a stable and well-tolerated pharmacological treatment for hypertension, dyslipidemia, or thyroid replacement will not be excluded as long as they continue to take their medication at the same dose and at the same time(s) of day.