Restoring Metabolic and Reproductive Health With Sleep in PCOS Study, CPAP Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Heather Huddleston, MD
heather.huddleston@ucsf.edu
415-885-3674
Backup
Jacob Christ, MD
Jacob.Christ@ucsf.edu
Time Frame
Start Date: 2022-12-22
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 20
Treatments
Active_comparator: CPAP Group
Participants randomized to CPAP will initiate CPAP therapy at the beginning of the study.
Placebo_comparator: Delayed CPAP Group
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.
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov