Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT07871149

Conditions

PCOS

PCOS (Polycystic Ovary Syndrome)

OSA

OSA - Obstructive Sleep Apnea

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Continuous Positive Airway Pressure (CPAP)

Study Details

Brief summary:

The goal of this study is to obtain pilot data investigating the effects of sleep apnea on mitochondrial function and cellular metabolism in Polyendocrine Metabolic Ovarian Syndrome (PMOS) patients.

Conditions

PCOS

PCOS (Polycystic Ovary Syndrome)

OSA

OSA - Obstructive Sleep Apnea

Study ID

NCT07871149

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women 18-40 years old
  • PMOS diagnosis
  • Sleep Apnea (AHI>5) diagnosed by home sleep test (WatchPAT One)
  • BMI< 50.0

Exclusion Criteria:

  • Regular adherent CPAP use per clinical guidelines
  • Any history of bleeding disorders
  • Current use of anti-coagulant medication
  • Hemoglobin <11.6 g/dL
  • Currently pregnant, pregnant within the last year, or gave birth within the last year
  • Any underlying disease likely to limit life span and/or increase risk of interventions including cardiovascular disease (e.g. unstable angina, heart failure requiring hospitalization in the past 6 months, significant heart block or arrhythmias, NYHA Class>2), pulmonary disease with dependence on oxygen or daily use of bronchodilators, cancer requiring treatment in the past 5 years unless the prognosis is considered good, active or chronic infection, thyroid disease and other endocrine disorders (e.g. Cushing syndrome, acromegaly), hepatitis or other chronic gastrointestinal disease (pancreatitis, inflammatory bowel disease), renal disease, significant anemia, recent surgery or significant abdominal surgery, major psychiatric or any eating disorder, acute coronary syndrome or stroke in the past 6 months

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Treated

Treated with Continuous Positive Airway Pressure (CPAP).

no intervention: Untreated

Interventions

Continuous Positive Airway Pressure (CPAP)

Two nights of CPAP treatment for OSA.

Primary outcome measure

  • Complex I and II/Electron Transport System Capacity [ Time Frame: Muscle biopsy will be collected during the treated condition and untreated condition. Mitochondrial function will be compared from both. These take place in a random order, 2-4 weeks apart. ]

Central Contacts and Locations

Central contacts

Bonnie Olivia Hughes

773-834-7809bhughes8@bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Bonnie Olivia Hughes

773-834-7809bhughes8@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • PCOS
  • OSA
  • PMOS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.