Smart Sleep In-home Validation Extension Study
Condition: Healthy; Sleep Deprivation; Insufficient Sleep Syndrome
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      This study is a nonrandomized, unblinded, uncontrolled case series clinical trial validating
      the SmartSleep product, including SleepMapper app in the home setting. It is intended to
      provide data related to product use and cognitive testing incorporating a longer baseline
      period for comparison purposes. It will include adults (21-50 yr. old) who are working full
      time and report shortened sleep due to lifestyle. For the purposes of this study, shortened
      sleep is defined as sleeping at least 5 hrs. of sleep per night, and sleeping less than or
      equal to 7 hrs. at least 3 nights per week. Participants also increase their sleep duration
      by ≥ 1 hour on the weekends. In addition, participants report a sleep latency ≤ 30 minutes
      less than or equal to 3 nights per week. Participants are generally healthy individuals who
      have not been diagnosed with any sleep-related medical conditions. In addition, participants
      diagnosed with major organ system diseases or requiring oxygen therapy are excluded from
      participation. Up to 75 individuals will be consented in order to complete a total of 50
      participants using a nonrandomized design. The study involves an initial screening visit
      followed by home use of the SmartSleep device with SleepMapper app. The home use will include
      an initial week of baseline use followed by 3 weeks of use with boost on. Study staff will
      contact participants after the first week of use as a reminder. Participants will be asked to
      complete a battery of cognitive tests upon wake up each morning. Participants will be asked
      to complete a question twice daily during the home use period. Additional phone calls may
      occur on an as needed basis if issues arise. The final visit will be an in facility visit in
      which all study equipment will be returned. The anticipated study duration will be up to 6
      weeks (including the 4 weeks of use period).
    

Detailed description: 
      Study procedures

      Visit 1 (Screening) Procedures (up to 2 hours):

      Participants will be asked to report to the research site for a daytime visit. A detailed
      interview will be performed verifying eligibility criteria, as well as a review of work and
      non-work schedules. After a full explanation of the protocol and after all the participants'
      questions have been answered, they will be asked to sign the consent form.

      Participants will complete the following baseline information:

      Demographics Questionnaires Medical History Questionnaire Review of Current Medications
      Height, Weight, Head Measurements Cognitive Assessment training

      Once eligibility confirmed, participants will be trained in the use of the SmartSleep device,
      including pairing and syncing of the SleepMapper app

      Home Use (weeks 1-4) All participants will be asked to wear the device consecutively every
      night. The anticipated study participation is expected to be one month of use (+ 2 weeks
      based on participant schedule). All participants will wear the device for 1 week of baseline
      use. Post one week of use (+/- 2 days), participants will the active mode. Participants will
      continue nightly home use of the SmartSleep with boost enabled for the next 3 weeks.

      Participants will be asked to complete the cognitive testing daily after wake up. Cognitive
      tests should be performed at the same time each morning following the same routine.

      Participants will be asked to complete the a question twice daily.

      During the study if a participant's medical history or medication changes, they will be asked
      to inform the study team. Participants will be asked during the course of the study if they
      experience any discomfort, red marks, etc.

      Study completion (final visit) Participants will be asked to return to the lab for a final
      study visit. They will be asked to bring their study materials.
    

Intervention name(s): SmartSleep Boost On; SmartSleep Boost Off
Intervention type(s): Device; Device
Intervention description(s): SmartSleep device can be configured to two different settings. SmartSleep Boost On setting provides soft audio tones during the night.
It's a non-invasive portable light weight device designed to stimulate deep slow wave sleep (SWS).; SmartSleep device can be configured to two different settings. SmartSleep Boost Off provides no audio tones.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: 1 week baseline, 3 weeks active condition
Masking: None (Open Label)
Primary purpose: Treatment