PMOS in OSA Pilot Study

NCT07871149 — Not applicable, Recruiting, 10 participants, University of Chicago

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Metabolic Changes in PMOS Patients With Obstructive Sleep Apnea (OSA) Pilot Study

RegistryNCT07871149
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none, other
Enrollment10 (Estimated)
SponsorUniversity of Chicago (Other)
ConditionsPCOS, PCOS (Polycystic Ovary Syndrome), OSA, OSA - Obstructive Sleep Apnea
InterventionsContinuous Positive Airway Pressure (CPAP) (Device)
Datesstart 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2028-10-01 (estimated), first posted 2026-10-13, last updated 2026-10-13
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for PCOS All trials for PCOS (Polycystic Ovary Syndrome) All trials of Continuous Positive Airway Pressure (CPAP)

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
TreatedActive comparatorDevice: Continuous Positive Airway Pressure (CPAP)Treated with Continuous Positive Airway Pressure (CPAP).
UntreatedNo intervention
  • Continuous Positive Airway Pressure (CPAP) (Device): Two nights of CPAP treatment for OSA.

+Outcome measures

Primary outcomes

  • Complex I and II/Electron Transport System Capacity [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.]: 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.

+Eligibility

Sex: Female, ages: 18 Years to 40 Years

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

+Locations (1)

FacilityCityCountryStatus
University of ChicagoChicago, IllinoisUnited StatesRecruiting