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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT02721251
Eligibility Criteria:
Inclusion Criteria:
* Veteran
* 18-65 years of age
* Moderate-severity OSA \[\[Apnea-hypopnea index (AHI) 15 at screening\]
* Overweight/obese
* Physically inactive
* BMI 28
* Sedentary lifestyle (planned activity for purpose of health \< 2 days/week)
* Stable weight Not engaged in weight loss study or program
* Stable medications Medications for thyroid, cholesterol, blood pressure, and other conditions at same dose for 2 months
* Capable of signing consent and willing to provide informed consent and accept randomization assignment
Exclusion Criteria:
* Current OSA treatment Current use of continuous positive airway pressure (PAP), dental devices, etc. for OSA treatment. Past PAP or oral appliances are not exclusions if discontinued 2 months before study
* Significant disease: known or signs/symptoms of cardiovascular, metabolic, or pulmonary disease
* Uncontrolled hypertension: Blood pressure \> 159/99 mmHg
* Unable to exercise: musculoskeletal, orthopedic, neuromuscular, or other conditions that do not allow exercise or where exercise is contraindicated
* Any accident attributable to sleepiness in previous 3 years
* Current pregnancy/planning to become pregnant
* Clinically judged unsuitable as evaluated by supervising medical physician
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02721251
Study Brief:
Protocol Section:
NCT02721251