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

NCT05920694 | Active Not Recruiting FDA Device

• 1 other identifier: 22-36861
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea; Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

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

  The percent of newly synthesized fatty acids (DNL, %) will be measured using a stable isotope (deuterated water) and mass spectrometry.

  Baseline and 12 weeks

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

  The aim is evaluate the effect of treating OSA with CPAP on biochemical hyperandrogenism in individuals with PCOS.

  Baseline and 12 weeks

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

  Glucose Tolerance Test is used to measure of insulin secretion rate.

  Baseline and 12 weeks

Study Arms (2)

CPAP Group

ACTIVE COMPARATOR

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

Device: Continuous Positive Airway Pressure Device (CPAP)

Delayed CPAP Group

PLACEBO COMPARATOR

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.

Other: Delayed Continuous Positive Airway Pressure Device (CPAP)

Interventions

Delayed Continuous Positive Airway Pressure Device (CPAP) OTHER

Metabolic studies will be performed before and after the study period of 12 weeks. After 12 weeks, participants will immediate receive CPAP therapy, which is currently the first-line standard of care for treatment of patients with OSA, both with and without hypoxia.

Delayed CPAP Group

Continuous Positive Airway Pressure Device (CPAP) DEVICE

Metabolic studies will be performed before and after initiation of CPAP therapy, which is currently the first-line standard of care for treatment of patients with OSA, both with and without hypoxia.

CPAP Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Heather Huddleston, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 27, 2023
• Study Start: December 22, 2022
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)