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:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT05104450
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of obstructive sleep apnea (OSA) on sleep study (sleep provider confirmed)
* Recent body mass index between 30.0-44.9 kg/m2 and at least one additional plausible BMI in last 12 months
* Access to DVD player, computer, and/or internet
* Able to participate fully in all study protocol/procedures including informed consent
Exclusion Criteria:
* Inability to speak, read, or understand English
* Recent or active weight loss interventions including use of prescription weight-loss medications, participation in group or individual weight loss programs provided by trained personnel, and prior bariatric surgery or plans for bariatric surgery during the study period.
* Expected weight loss because of alternate explanations such as from illness
* High variability in weight due to fluctuations in volume status (e.g. ascites - liver disease, chronic heart failure)
* Safety and/or adherence concerns due to severe physical or mental health issues, or life expectancy \<24 months
* Pregnant, lactating, or planning to become pregnant during the study period
* Participation in other intervention studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05104450
Study Brief:
Protocol Section:
NCT05104450