← Back to Search

Procedure

CPAP for Polycystic Ovary Syndrome

N/A

Recruiting

Led By Heather Huddleston, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects found to have moderate to severe OSA (AHI >15)

Ages 18-40

Must not have

Treatment for asthma

Diabetes mellitus (fasting glucose ≥126 mg/dL or 2-h glucose ≥200 mg/dL or HGB A1c ≥6.5%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 weeks

Summary

This trial looks at how Polycystic Ovary Syndrome and Obstructive Sleep Apnea may be related, and how treatment with CPAP may improve insulin resistance.

Who is the study for?

This trial is for adults aged 18-40 with Polycystic Ovary Syndrome (PCOS) and moderate to severe Obstructive Sleep Apnea (OSA). Participants should have a BMI of 25-45, high fasting insulin levels, and meet specific PCOS criteria. Pregnant or breastfeeding individuals, those with untreated hypertension, HIV/hepatitis, asthma treatment, tobacco/alcohol use, prior OSA treatment or diabetes are excluded.

What is being tested?

The study is examining the effects of two types of CPAP devices on metabolic and reproductive health in people with PCOS and OSA. It aims to understand how treating low blood oxygen at night affects insulin resistance.

What are the potential side effects?

CPAP devices may cause discomfort such as nasal congestion or dryness, skin irritation from the mask strap, headaches or ear pressure changes. Rarely it can lead to lung infection if not cleaned properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with moderate to severe sleep apnea.

Select...

I am between 18 and 40 years old.

Select...

I have PCOS with high androgen levels and irregular ovulation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am receiving treatment for asthma.

Select...

I have diabetes with high blood sugar levels.

Select...

I am currently using oral contraceptives.

Select...

I often feel very sleepy during the day or my blood pressure is often above 150/90.

Select...

I have HIV or hepatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants showing a change in fractional de novo lipogenesis (DNL, %)

Number of participants showing a change in free testosterone (pg/mL)

Number of participants showing a change in insulin secretion rate (picomol/min)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: CPAP GroupActive Control1 Intervention

Participants randomized to CPAP will initiate CPAP therapy at the beginning of the study.

Group II: Delayed CPAP GroupPlacebo Group1 Intervention

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.

0 / 8Eligibility criteria met