Pilot Study Comparing the Effectiveness of Two Different Methods of Acoustic Stimulation

Study Summary

This study is a randomized, single-blind, sham-controlled pilot cross-over trial comparing the feasibility, and efficacy of 2 nights of in lab use with active versus sham conditions in adults with sleep restricted schedules. The study involves the testing of 2 different prototypes both in the sham and active conditions The expected duration of the study for each participant is up to 5 weeks. It will include adults (21-50 yr. old) who report shortened sleep due to lifestyle. For the purposes of this study, shortened sleep is defined as sleeping at least 5.5 of sleep per night, and sleeping less than or equal to 7 hours of sleep +/- 15 minutes on at least 3/5 work/school nights. Participants also increase their sleep duration by ≥ 1 hour on non-work/school days. In addition, participants report a sleep latency ≤ 30 minutes and wake after sleep onset ≤ 30 minutes. Participants are generally healthy individuals who have not been diagnosed with any sleep-related medical conditions such as obstructive sleep apnea, insomnia, difficulty falling asleep on a nightly basis and deny difficulty staying asleep if awoken during sleep. In addition, participants diagnosed with major organ system diseases or requiring oxygen therapy are excluded from participation. Up to 60 individuals will be consented in order to complete a total of 10 participants using a cross over design. The study involves an initial screening visit followed by 1 week of actigraphy measurement to determine eligibility. Post eligibility, participants will undergo an additional week of actigraphy measurement. Participants will complete 2 overnight visits in the sleep lab per week, with one washout night in between. They will be randomly assigned to sham or active condition during the first of the overnight visits, and the other condition during the second overnight condition. Participants will return to the lab on the same nights the next week and receive the second device in both conditions. Participants will be

Primary Outcome

It is hypothesized that one night of in-lab use of a PowerSleep system (Prototype 1) or NorthWestern (Prototype 2) under an active condition (tones played to increase slow-wave activity), as compared to one night of in-lab use of the same PowerSleep system (prototype 1) or Prototype 2 under a sham condition (no tones played) will result in a significant increase (≥ 5%) in cumulative or average slow-wave activity (SWA) in nonREM sleep across the whole night of sleep compared to sham. Note: The re

Interventions

• DEVICE PowerSleep Stim
• DEVICE PowerSleep Sham
• DEVICE Northwestern Stim
• DEVICE NorthWestern Sham