Clinical trial · Interventional
Restoring Metabolic and Reproductive Health With Sleep in PCOS Study, CPAP Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, the researchers are trying to learn more about the relationship between Polycystic Ovary Syndrome and Obstructive Sleep Apnea (OSA). Obstructive Sleep Apnea is a sleep-related breathing disorder that involves a decrease or complete stop in airflow. The purpose of this study is to find out why some people with obstructive sleep apnea have higher levels of insulin resistance, and the investigators will study the role of hypoxia (low levels of oxygen in the blood at night) in insulin resistance and see if insulin resistance improves during your treatment with CPAP.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obstructive Sleep Apnea | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuous Positive Airway Pressure Device (CPAP) | Device | — | UNRESOLVED |
| Delayed Continuous Positive Airway Pressure Device (CPAP) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CPAP Group
- description
- Participants randomized to CPAP will initiate CPAP therapy at the beginning of the study.
- interventionNames
- Device: Continuous Positive Airway Pressure Device (CPAP)
- type
- PLACEBO_COMPARATOR
- label
- Delayed CPAP Group
- description
- Participants randomized to delayed CPAP (waitlist control) will initiate CPAP therapy immediately after 12 weeks. The investigators recognize that adherence to CPAP therapy is a common barrier to effective clinical treatment of OSA and to rigorous research on CPAP and has been significantly correlated with improvements in insulin resistance, including in a small of study of women with PCOS. After receiving this device, participants can meet with a study psychiatrist and his team within 3 days of initiating CPAP therapy and as needed for up to a month after initiating therapy. No visits in this time period will be billed to insurance.
- interventionNames
- Other: Delayed Continuous Positive Airway Pressure Device (CPAP)
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available