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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT02505594
Eligibility Criteria:
Inclusion Criteria:
* BMI \< 30
* OSA group: diagnosis of untreated moderate-to-severe OSA (apnea-hypopnea index (AHI) ≥ 15 events/h).
* Control group: no OSA (AHI \< 5 events/h).
Exclusion Criteria:
* Currently using Continuous Positive Airway Pressure (CPAP) or oral appliance treatment for OSA
* Uncontrolled cardiac co-morbidity, e.g. ischemic heart disease, heart failure, or valvular heart disease that would prevent exercise
* Uncontrolled pulmonary co-morbidity, e.g. asthma or chronic obstructive pulmonary disease (COPD)
* Comorbidities that may severely impair peripheral circulation, e.g. uncontrolled diabetes mellitus, or systemic scleroderma
* Neurological conditions limiting the ability to perform walking or cycling
* Orthopedic condition limiting the ability to perform walking or cycling
* Current smokers, alcohol (\> 3 oz/day) or use of illicit drugs.
* Psychiatric disorder, other than mild and controlled depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT02505594
Study Brief:
Protocol Section:
NCT02505594