Feasibility, Effectiveness and Efficacy of the PowerSleep Device

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.

PowerSleep is a non-invasive portable light weight device designed to stimulate deep slow-wave sleep and thereby reduce daytime sleepiness associated with insufficient sleep or poor perceived sleep quality. The concept is to stimulate deep sleep also known as (Slow-Wave Sleep \[SWS\]), to compensate for insufficient sleep duration by increasing sleep intensity or to improve sleep quality by increasing sleep intensity. Sleep intensity can be objectively assessed by Slow-Wave Activity (SWA). In normal individuals, a reduction in amounts of SWA consistently results in reduced alertness with impaired performance due to cognitive and memory deficits.

The PowerSleep device delivers acoustic stimuli that are calibrated to stimulate SWA without awakening the user. The PowerSleep device is wearable and non-invasive, consisting of a headband with 4 integrated electrodes and headphones covered by speaker foam over each ear. The headband is connected via a tether cable to an upper arm band which houses the EEG amplifier and electronics of the device. Both the headband and the arm band are adjusted via a Velcro strap. The device also includes a right mastoid electrode. The device monitors and records EEG throughout the night, and is capable of on-line identification of sleep stages and continuous EEG analysis. The armband contains the device electronics. EEG data collected by the PowerSleep device can be transferred to the computer by a technician after home use and used to assess sleep quality. Soft audio tones will be administered via the speakers during deep sleep throughout the night.

Participants may be pre-screened over the phone to determine eligibility. A screening script will include a general review of key inclusion and exclusion criteria, and questionnaires to assess the risk of an undiagnosed sleep disorder. Participants that meet all eligibility criteria will be asked to come into the lab for a screening daytime visit (Visit 1) involving a detailed presentation of the study and an interview to verify eligibility and work schedules.

Participants who are interested and eligible will be consented. Participants will scheduled for up to 6 daytime visits, 2 overnight lab visits, and provided with information on use of the actigraph and PowerSleep device at home. At Daytime Visit 2, participant qualification will be assessed based on the PowerSleep device data. Qualifying participants will be randomized and receive a PowerSleep device for home use.

Participants will use the PowerSleep device with active and sham study arm for one work week each, with a washout period in between. At the end of each study arm work week, the participants will report to the lab for an overnight stay followed by daytime in- lab testing to complete daytime function assessments and questionnaires. Compliance data from the PowerSleep device will be reviewed at each visit, and only qualifying participants will continue in the study.

Daytime Visit 1 Procedures (Up to 2 hours):

Initial evaluation and anthropometric measurements:

Participants will be asked to report to the sleep lab for a daytime visit. A detailed interview will be performed verifying eligibility criteria, and review of work and non-work schedules. After a full explanation of the protocol and after all the participants' questions have been answered, participants will be asked to sign the consent form.

Participants will be asked to fill out the baseline questionnaires, medical history, review of systems, and current medications.

Participants will have height, weight, waist to hip ratio, neck circumference, heart rate (after being seated for approximately 5 minutes), temperature, respiratory rate and blood pressure (systolic and diastolic after being seated for approximately 5 minutes) recorded.

Participants will be trained in the use of the sleep logs, actigraphy and be fitted and trained on the device use for baseline night data collection.

Actigraphy screening:

Participants will be asked to wear an actigraph and complete a daily sleep logs for up to 7 days (including at least 3 workdays) including monitoring a sleep schedule. Participants will receive instructions from the study staff on how to wear the actigraph and will be asked to keep to a regular sleep schedule.

Baseline Night training:

Participants will be asked to wear the PowerSleep device at home for one night. During the Daytime Visit, participants will be fitted with PowerSleep device and trained on its use for data collection on the baseline night.

Participants will receive a phone call from the study staff as a reminder to wear the device on the appropriate night for the baseline data collection.

After the initial screening, participants will be asked to report to the lab (Daytime Visit 2) for equipment and sleep log return, and download and review of study data.

Daytime Visit 2 Procedures (2 hours):

Participants will return to the sleep lab (within 1 week of daytime visit 1, ±2 days) with the actigraph, sleep diary and PowerSleep device for review by the study staff.

Actigraphy review:

The sleep log and actigraph data will be reviewed by a trained technologist prior to randomization.

Baseline Night review:

The PowerSleep device data will be downloaded and reviewed. Qualifying participants will be asked to continue wearing the actigraph and completing the sleep diary throughout the study.

Participants will be asked questions related to the comfort, the ease of use and overall device use after the baseline night

Device home use:

Once eligibility has been confirmed, participants will be re-trained on the study device take home use. Participants will be asked to use the device during 5 consecutive workday nights (Monday - Thursday) at home and Friday night overnight in the lab in order to be eligible for continued study participation. In addition, at least 4 hours of device use per night is required for study continuation. Participants will be instructed that the device must be used nightly; and imperative to be used prior to morning recall assessment cognitive measures (Monday nights (initial night) of each work week use and Friday nights during the overnight in lab visit).

Participants will be randomly assigned to active or sham treatment during the first work week in a 1:1 ratio. Participants and study staff will be blinded to the treatment during each work week.

Active treatment: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.

Sham treatment: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.

Daytime assessments:

Participants will also be trained on daytime assessments and asked to complete a battery at home in the morning.

Overnight in-lab visit (8-12 hours) followed by Daytime in-lab testing (8 hours): On Friday evening participants will be asked to return to the sleep lab for an overnight visit. Participants will be asked to report to the lab 1.5 to 2 hours before bedtime with all study materials including the logs, questionnaires, device and laptop. Participants will be asked to go to bed and awaken at the same time as a regular work-night sleep schedule. Participants will be asked to continue to wear the PowerSleep device during this overnight visit.

On the morning of the day following the overnight in lab visit work week 1, participants will remain in the lab and undergo the following assessments:

* Review of any reported changes in medical condition since previous visit
* Collect sleep logs
* Collect PowerSleep device
* Data download from actigraph and study device with verification of device compliance
* Collect daily home assessments of daytime function
* Three consecutive blood pressure measurements at 5 min intervals while sitting
* Complete questionnaires
* Complete 3 minute Psychomotor Vigilance Task (PVT)
* active vs sham
* Complete morning recall of Paired Associated Learning (PAL) task
* A single fasting blood draw for glucose and insulin
* Breakfast- participants can have one (1) 6 ounce cup of coffee or caffeine equivalent. Coffee or equivalent is only for those who routinely drink caffeine in the morning.
* 4- nap Multiple Sleep Latency Test (beginning standardly 2 hours post wake-up): each nap is followed by a battery of assessments which includes questionnaires and a the 3 min PVT.

Participants will enter into a washout period of 1 to 2 weeks at which time participants will continue to wear the actigraph and complete sleep logs and will not use the Powersleep device.

Daytime Visit 4 (1 hour):

Participants will report to the lab and receive the PowerSleep device for the 2nd work week use period. Participants will be re-trained on the home use of the device and will be asked to use the device during 5 consecutive workday nights. Sleep logs will be collected and reviewed with actigraph data.

Participants will be crossed over to other study arm at the time of this visit.

Overnight in-lab visit (8-12 hours) followed by Daytime in-lab testing (8 hours):

This is a repeat of the above day-time in lab testing.

Participants will be asked to continue wearing actigraph over the weekend for the purposes of collecting data related to recovery sleep at end of study.

Daytime Visit 6 (30 minutes) Participants will be asked to return to the lab for a quick visit to return actigraph and data download capturing recovery sleep.

Participants will be asked questions related to the comfort, the ease of use and overall device use after two weeks of home use.

Statistics:

Descriptive statistics will be presented for all variables of interest. Continuous data will be summarized by mean, standard deviation, median, minimum, and maximum values. Categorical data will be presented as frequencies and percentages. Endpoints will be compared between the active and sham conditions as paired samples. Continuous endpoints that are not normally distributed may undergo appropriate transformation to fit the assumptions of a paired t-test. Otherwise, the nonparametric Wilcoxon Signed Ranks test will be used. Categorical endpoints will be examined with the McNemar Test. All tests will be conducted at a significance level of p \< 0.05.

Data quality will be assessed by the blinded personnel scoring the PSGs (Polysomnography) and device data. Criteria will be defined regarding whether the data sets are scorable and of sufficient duration to be included in the statistical analysis. These criteria will be consistently applied across all participant records and described in any study publications or reports.

Eligibility Criteria:
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