Feasibility, Effectiveness and Efficacy of the PowerSleep Device
Condition: Sleep; Sleep Disorders Not Due to A Substance or Known Physiological Condition
MeSH terms: Sleep Wake Disorders
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Powersleep; Sham Powersleep
Intervention type(s): Device; Device
Intervention description(s): Participants will receive 5 nights of stimulation; Participants will receive 5 nights of no stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment