Is My Sleep Tracker Tracking my Sleep?
Status unconfirmed
Conditions studied: Obstructive Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT06174558
- Run by
- Respiratory Specialists
- People needed
- 86
- Starts
- 2024-02-01
- Expected to finish
- 2024-08-01
- Last updated by the study team
- 2024-01-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.).
Where it is running
- Respiratory Specialists — Wyomissing, Pennsylvania, United States
Full record on ClinicalTrials.gov
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