PCOSNCT07871149
PMOS in OSA Pilot Study
A study testing Continuous Positive Airway Pressure (CPAP) in people with PCOS and PCOS (Polycystic Ovary Syndrome), run by University of Chicago at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- PCOS, PCOS (Polycystic Ovary Syndrome), OSA
- What is being tested?
- Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18-40 years old
- PMOS diagnosis
- Sleep Apnea (AHI>5) diagnosed by home sleep test (WatchPAT One)
- BMI< 50.0
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Bonnie Olivia Hughes, 773-834-7809, bhughes8@bsd.uchicago.edu
About this study
Official title: Metabolic Changes in PMOS Patients With Obstructive Sleep Apnea (OSA) Pilot Study
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.
- Being tested
- Continuous Positive Airway Pressure (CPAP)
- Keywords
- PCOS, OSA, PMOS
- Medical subject headings
- Polycystic Ovary Syndrome, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Device
Two nights of CPAP treatment for OSA.
| Study group | Role | What they receive |
|---|---|---|
| Treated | Active comparator | Treated with Continuous Positive Airway Pressure (CPAP). Receives: Device: Continuous Positive Airway Pressure (CPAP) |
| Untreated | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871149
- Sponsor's protocol ID
- IRB26-1066
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Changes in PMOS Patients With Obstructive Sleep Apnea (OSA) Pilot Study
- ClinicalTrials.gov ID
- NCT07871149
- Acronym / sponsor ID
- IRB26-1066
- Keywords
- PCOS, OSA, PMOS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | Active comparator | Device: Continuous Positive Airway Pressure (CPAP)Treated with Continuous Positive Airway Pressure (CPAP). |
| Untreated | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women 18-40 years old
- PMOS diagnosis
- Sleep Apnea (AHI>5) diagnosed by home sleep test (WatchPAT One)
- BMI< 50.0
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP)Two nights of CPAP treatment for OSA. | Device | Treated |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure (CPAP) in people with PCOS and PCOS (Polycystic Ovary Syndrome), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bonnie Olivia Hughes (773-834-7809, bhughes8@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.