Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT06174558
Eligibility Criteria:
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.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06174558
Study Brief:
Protocol Section:
NCT06174558