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RecruitingNCT07871149Updated Oct 13, 2026

PMOS in OSA Pilot Study

An interventional study of Continuous Positive Airway Pressure (CPAP) in PCOS, PCOS (Polycystic Ovary Syndrome) and OSA, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by University of Chicago · Not applicable, Interventional, and Other

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the detailed description

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age, with symptoms commonly manifesting in reproductive abnormalities. PCOS was recently reclassified as Polyendocrine Metabolic Ovarian Syndrome (PMOS) to better describe the multi-systemic and endocrine nature of the disorder. Beyond reproductive concerns, PMOS patients are at significantly higher risk of developing diabetes. Similarly, PMOS patients are at a higher risk of presenting with Obstructive Sleep Apnea (OSA). While it is known that OSA contributes to metabolic dysfunction, this effect has been shown to be disproportionately larger in individuals with pre-existing metabolic dysfunction.With the wider recognition of PMOS as a metabolic disorder, and despite the known link between PMOS and OSA, there are no studies investigating the effects of OSA in a PMOS population. Metabolic dysfunction in skeletal muscle is part of the PMOS phenotype. The research team will use high resolution respirometry on skeletal muscle biopsies- a cutting-edge method for assessing changes in mitochondrial function and cellular metabolism. Muscle biopsies will be done with and without OSA treatment (Continuous Positive Air Pressure- CPAP) as an investigation into the effect of OSA on mitochondrial function.

02

Conditions studied

  • PCOS
  • PCOS (Polycystic Ovary Syndrome)
  • OSA
  • OSA - Obstructive Sleep Apnea

Keywords

  • PCOS
  • OSA
  • PMOS
03

In context

Polycystic Ovary Syndrome

975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.

This study's planned enrollment of 10 is below the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Active comparator
    Treated

    Treated with Continuous Positive Airway Pressure (CPAP).

    Device: Continuous Positive Airway Pressure (CPAP)

  • No intervention
    Untreated

Interventions

  • DeviceContinuous Positive Airway Pressure (CPAP)

    Two nights of CPAP treatment for OSA.

06

What researchers measure

Primary outcomes

  1. Complex I and II/Electron Transport System Capacity

    A measure of mitochondrial function that takes a ratio of the phenotypic maximal respiration of mitochondria isolated in muscle fibers taken via biopsy relative to the maximal non-physiological respiratory capacity as determined via the maximal rate of oxygen consumption induced by a chemical uncoupler.

    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.

07

Study locations

1 of 1 sites recruiting
  • University of Chicago
    Chicago, Illinois 60637, United States
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07871149
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Bonnie Olivia Hughes
Contact
bhughes8@bsd.uchicago.edu
773-834-7809

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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