An interventional study of SmartSleep Boost On and SmartSleep Boost Off in Healthy, Sleep Deprivation and Insufficient Sleep Syndrome, sponsored by Philips Respironics. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-11-16.
Sponsored by Philips Respironics · Not applicable, Interventional, and Treatment
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).
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.
300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.
This study's enrollment of 61 is above the median of 45 across 248 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →Philips Respironics is the lead sponsor of 40 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Suffer from short sleep due to lifestyle
Exclusion Criteria:
Diagnosed as having any of the following conditions (via self-report):
Participants wear the device for baseline data collection in boost off mode. There is no intervention. This is known as SmartSleep Boost Off mode.
Device: SmartSleep Boost Off
Participants wear the device for 3 weeks in boost on mode. This is known as SmartSleep Boost On mode.
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).
SmartSleep device can be configured to two different settings. SmartSleep Boost Off provides no audio tones.
The effects of the auditory stimulation delivered by the SmartSleep device in adults with shortened sleep schedules due to lifestyle as determined by changes in the cumulative (CSWA) or average slow-wave activity.
Efficacy will be evaluated based on the average of seven nights of use collecting baseline data compared to the average of twenty one nights of active SmartSleep, while in the home setting. SWA accumulation over Non-Rapid Eye Movement (NREM) sleep (CSWA) will be analyzed for each night in the active condition using as reference the average CSWA across baseline nights.
Time frame: 4 weeks
Change in performance of the Matrix reasoning task (MRT) correlated to the changes in CSWA over the trial period.
Performance of the MRT during baseline and active use weeks of the SmartSleep Device will be compared to changes in CSWA over the trial period.
Time frame: 4 weeks
Change in performance of the Digital Symbol Substitution Task (DSST) correlated to the changes in CSWA over the trial period.
Performance of the DSST during baseline and active use weeks of the SmartSleep Device will be compared to changes in CSWA over the trial period.
Time frame: 4 weeks
Change in performance of the Psychomotor Vigilance Testing -Brief (PVT) correlated to the changes in CSWA over the trial period.
Performance of the PVT during baseline and active use weeks of the SmartSleep Device will be compared to changes in CSWA over the trial period.
Time frame: 4 weeks
Change in sleepiness/alertness as measured by a 7 point scale correlated to the changes in CSWA over the trial period.
Change in sleepiness/alertness as measured by a 7 point scale during baseline and active use weeks of the SmartSleep Device will be compared to changes in CSWA over the trial period.
Time frame: 4 weeks
Plan to share: No — No. This data will remain with Florida Lung \& Sleep Associates and Philips
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Philips Respironics