Smart Sleep In-home Validation Extension Study

Completed · Not applicable

Conditions studied: Healthy, Sleep Deprivation, Insufficient Sleep Syndrome

In brief

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).

Key facts

Study ID

NCT03665844

Run by

Philips Respironics

People needed

61

Starts

2018-08-14

Expected to finish

2018-11-07

Last updated by the study team

2018-11-16

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide informed consent
• Live in the US
• Able to read, write and speak English
• Adult volunteers aged 21-50
• Smartphone owner (iOS 9+ or Android 5.0+ OS)
• Access to home Wi-Fi for syncing of SmartSleep data and cognitive testing
• Working full time schedule [Note: Full time is considered a 32 hour work week start time at 7am or later]
• Suffer from short sleep due to lifestyle
• Gets less than 7 hours of sleep at least 3 days a week (via self-report)
• Get at least 5 hours of sleep per night 7 nights a week (via self-report)
• Gets 1 extra hour of sleep on the weekends (via self-report of extended nightly sleep or daytime nap)

You may not qualify if…

• Individuals who self-report severe contact dermatitis or an allergy to silver
• Diagnosed as having any of the following conditions (via self-report):
• Sleep Apnea
• Insomnia
• Restless legs syndrome
• Parasomnia
• Epilepsy/Seizures
• Diagnosed as having any major organ system disease such as congestive heart failure, neuromuscular disease, renal failure, cancer, chronic obstructive pulmonary disease, respiratory failure or respiratory insufficiency, or patients requiring oxygen therapy (via self-report)
• High Risk of Obstructive Sleep Apnea (OSA) based on Questionnaire
• Daily caffeine intake > 650 mg
• History of moderate hearing loss (via self-report)
• Currently working night shift or rotating shift
• Head circumference <54 cm (21 in) or >66 cm (26 in)
• Individuals who self-report taking longer than 30 minutes more than 3 times a week to fall asleep once they turn lights off
• Individuals who self-report regularly taking sleeping pills (more than once per week), including prescription or over the counter (OTC) pills such as Ambien, Tylenol PM or Zzzquil
• Pregnant (via self-report)
• Employee of Philips or spouse of a Philips employee
• Employee (or spouse of an employee) of a company that designs, sells, or manufactures sleep-related products
• Not able to comply with study procedures

Where it is running

• Florida Lung & Sleep Associates — Lehigh Acres, Florida, United States

Full record on ClinicalTrials.gov

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