Improving metabolic and reproductive health in women with PCOS using CPAP for sleep apnea
Restoring Metabolic and Reproductive Health With Sleep in PCOS Study, CPAP Trial
This study is testing if using a CPAP machine for sleep apnea can help women with PCOS improve their insulin resistance and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05920694 on ClinicalTrials.gov |
What this trial studies
This study investigates the connection between Polycystic Ovary Syndrome (PCOS) and Obstructive Sleep Apnea (OSA), focusing on how OSA may worsen insulin resistance in women with PCOS. Researchers will enroll women aged 18-40 with moderate to severe OSA and PCOS to assess the effects of Continuous Positive Airway Pressure (CPAP) therapy on insulin resistance and overall metabolic health. The study aims to understand the role of nighttime hypoxia in insulin resistance and whether CPAP treatment can lead to improvements in metabolic and reproductive outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-40 with a diagnosis of PCOS and moderate to severe OSA.
Not a fit: Patients with diabetes, excessive daytime sleepiness, or those currently using oral contraceptives may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment approach for improving metabolic and reproductive health in women with PCOS who also suffer from OSA.
How similar studies have performed: While the relationship between OSA and PCOS is recognized, evidence regarding the impact of CPAP therapy specifically in PCOS populations is limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Heather Huddleston, MD — University of California, San Francisco
- Study coordinator: Heather Huddleston, MD
- Email: heather.huddleston@ucsf.edu
- Phone: 415-885-3674
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.