NCT03665844

Smart Sleep In-home Validation Extension Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Healthy
• Sleep Deprivation
• Insufficient Sleep Syndrome

Interventions

Type	Name	Description
DEVICE	SmartSleep Boost On	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).
DEVICE	SmartSleep Boost Off	SmartSleep device can be configured to two different settings. SmartSleep Boost Off provides no audio tones.

Timeline

• Start date: 2018-08-14
• Primary completion: 2018-11-07
• Completion: 2018-11-07
• First posted: 2018-09-11
• Last updated: 2018-11-16

Locations

1 site across 1 country: United States