Status:
NOT_YET_RECRUITING
Is My Sleep Tracker Tracking my Sleep?
Lead Sponsor:
Respiratory Specialists
Collaborating Sponsors:
The Reading Hospital and Medical Center
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Brief 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 accura...
Detailed Description
To date, there is an incomplete picture of the reliability of wearable device trackers to depict sleep quantity and sleep staging information. Prior studies have compared various iterations of wearabl...
Eligibility Criteria
Inclusion
- 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.).
Exclusion
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06174558
Start Date
February 1 2024
End Date
August 1 2024
Last Update
January 19 2024
Active Locations (1)
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1
Respiratory Specialists
Wyomissing, Pennsylvania, United States, 19610