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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT05920694
Eligibility Criteria:
Inclusion Criteria:
* Subjects found to have moderate to severe OSA (AHI \>15)
* PCOS diagnosis satisfies both the hyperandrogenic and oligo-ovulatory requirements of Rotterdam criteria
* Ages 18-40
* BMI 25-45 kg/m2
* Fasting insulin \>16
* At-risk score on Berlin Questionnaire
Exclusion Criteria:
* Current use of oral contraceptives
* Diabetes mellitus (fasting glucose ≥126 mg/dL or 2-h glucose ≥200 mg/dL or HGB A1c ≥6.5%)
* Treatment for asthma
* Regular tobacco use or alcohol consumption exceeding 1 drink/day
* HIV infection or infectious hepatitis
* Pregnancy or lactation within the past six months
* Prior OSA treatment
* Excessive daytime sleepiness as defined as \>16 on the Eppworth Sleepiness Scale or untreated or inadequately treated hypertension (\>150/90)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05920694
Study Brief:
Protocol Section:
NCT05920694