Is My Sleep Tracker Tracking my Sleep? (NCT06174558) | Clinical Trial Compass
UnknownNot Applicable
Is My Sleep Tracker Tracking my Sleep?
United States86 participantsStarted 2024-02-01
Plain-language summary
The purpose of this research study is to collect health and physiological data using commercially available wristband fitness tracker devices (FitBit and Garmin devices) to help determine their accuracy and reliability at measuring percent of night spent in REM sleep, oxygen desaturation, and apnea hypopnea index compared with currently available methods of in-laboratory polysomnogram and home sleep testing.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria:
* Age 18 or over
* Able to read and understand the informed consent document, and provide written consent.
* Referred to the Sleep Health Center for diagnostic polysomnogram.
* Agrees to complete standard Sleep Health Center questionnaires.
* Agrees to wear, in addition to standard polysomnogram equipment/leads, the GVS5 tracker, the FBI3 tracker, and the Alice NightOne Level 3 sleep study equipment.
* Agrees to permit review of fitness/sleep tracker physiologic data (for the study night, only) and Alice NightOne Level 3 sleep study and polysomnogram data.
* Agrees to provide review of specified demographic and clinical data, review of polysomnogram data and completion of study questionnaire data, to be stored in de-identified form.
* Undergo diagnostic polysomnogram.
Exclusion criteria
* Current atrial fibrillation (remote history of atrial fibrillation, but now in sinus rhythm, will not be excluded)
* Permanent pacemaker
* Chronic hypoxic respiratory failure, requiring supplemental oxygen.
* Multiple sleep latency testing or split-night polysomnogram testing.
* Inability to provide, or declines to provide, informed, written consent.
* Tattoos over the wrist/forearm that would preclude accurate measurement of fitness tracker variables.
* Anatomic injury or disability that would preclude wearing the tracker on the nondominant wrist (including injury, cast, etc.).
What they're measuring
1
Monitoring of Sleep Staging
Timeframe: Throughout study completion, approximately 5 months