Feasibility, Effectiveness and Efficacy of the PowerSleep Device

About this trial

Last updated 7 years ago

Study ID

CAI-16025-PSPIL-LO

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

21 to 50 Years

All Sexes

Trial Timing

Ended 9 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* Able to provide written informed consent prior to admission

* Able to read, write and speak English

* Adult volunteers aged 21-50 working full time; 5 consecutive days (M-F)

* Self-reported regular sleep schedule

* Self-reported sleep duration of > 5hrs. and ≤ 6.5hrs. (verified by 3 work days of ambulatory sleep monitoring with wrist actigraphy and daily logs)

* Self-reported sleep latency > 30 minutes no more than once / wk. (time to fall asleep)

* Self-reported wake after sleep onset ≤ 30 minutes

* Participants who regularly use an alarm clock during the work week and who self-report: i. Regular time in bed (TIB) on work days of ≤7 hours ii. Regular increase in sleep duration by ≥ 1 hour during non-work days as compared to work days, either by nocturnal bedtime extension of via a daytime nap

Exclusion Criteria

* Participation in another interventional study in the past 30 days.

* 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 shift 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.

* Pregnancy

* 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 OSA (Obstructive Sleep Apnea) based on STOP-BANG Questionnaire ("yes" on at least 3 of 7 questions)

* High Risk of Restless Legs Syndrome (RLS) based on Cambridge-Hopkins Screening questionnaire

* Excessive alcohol intake (self-report > 14 drinks / wk.)

* Self-report of binge alcohol consumption ( >5 drinks) on any one day during the week prior to the randomization, during the device use period, and during the wash-out period

* Excessive caffeine consumption (> 500mg/day combining all caffeinated drinks regularly absorbed during workdays.) Caffeine intake must be regular and maintained throughout study and on testing days (available at test sites)

* 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.

* Individuals who self-report moderate hearing loss.

* Inability to achieve appropriate headband fit.

* Planned air travel or travel across more than one time zone one month prior to and or during the anticipated period of the study with PowerSleep device use