Polycystic Ovary SyndromeNCT05920694
Restoring Metabolic and Reproductive Health With Sleep in PCOS Study, CPAP Trial
A study testing Continuous Positive Airway Pressure Device (CPAP) and Delayed Continuous Positive Airway Pressure Device (CPAP) in people with Polycystic Ovary Syndrome and Obstructive Sleep Apnea, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Obstructive Sleep Apnea
- What is being tested?
- Continuous Positive Airway Pressure Device (CPAP) and Delayed Continuous Positive Airway Pressure Device (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 30 Jul 2026
- 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
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
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.
Read the detailed description
Today, approximately 5 million Americans of reproductive age have Polycystic Ovary Syndrome (PCOS). The personal and public health burden of PCOS is high. People with PCOS are at elevated risk of infertility, endometrial cancer, obesity, diabetes, dyslipidemia and nonalcoholic fatty liver disease (NAFLD). Moreover, there is a paucity of treatments that address the metabolic and reproductive concerns of this disorder. Obstructive sleep apnea (OSA) is a recognized co-morbidity of PCOS that may exacerbate both metabolic and reproductive aspects of PCOS. Thus, treating OSA represents a potentially attractive tool to improve outcomes in PCOS. Indeed, continuous positive airway pressure therapy (CPAP) is a relatively inexpensive treatment for OSA that is safe for use in women in the reproductive years, even when pregnant or trying to conceive. However, evidence regarding the impact of CPAP use in PCOS populations is lacking, and, currently, screening and treatment of OSA is only considered standard of care to treat symptoms of excessive sleepiness or hypertension. Because an estimated 15-45% of people with moderate/severe OSA do not have these symptoms, treatment is not considered standard of care for the majority of persons with OSA and PCOS. From another study looking at sleep and PCOS, we will identify 20 subjects with moderate-to-severe OSA without excessive daytime sleepiness who will enroll in a CPAP trial. These subjects will undergo intensive multi-tissue insulin resistance testing and will be assigned treatment with CPAP or delayed treatment after 12 weeks after which all measures will be re-assessed. Accordingly, this proposal will address an unanswered question: Does CPAP provide metabolic or reproductive benefits in PCOS? The results will also better define potential mechanistic pathways linking OSA to insulin resistance and will determine whether CPAP improves key outcomes.
- Conditions
- Polycystic Ovary Syndrome, Obstructive Sleep Apnea
- Being tested
- Continuous Positive Airway Pressure Device (CPAP), Delayed Continuous Positive Airway Pressure Device (CPAP)
- 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 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| CPAP Group | Active comparator | Participants randomized to CPAP will initiate CPAP therapy at the beginning of the study. Receives: 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. Receives: Other: Delayed Continuous Positive Airway Pressure Device (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start22 Dec 2022
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Huddleston, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920694
- Sponsor's protocol ID
- 22-36861
- Status last verified
- Jan 2026
- First submitted
- 5 Jun 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Metabolic and Reproductive Health With Sleep in PCOS Study, CPAP Trial
- ClinicalTrials.gov ID
- NCT05920694
- Acronym / sponsor ID
- 22-36861
- Conditions
- Polycystic Ovary Syndrome, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 27 Jun 2023 (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.
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.
Detailed description
Today, approximately 5 million Americans of reproductive age have Polycystic Ovary Syndrome (PCOS). The personal and public health burden of PCOS is high. People with PCOS are at elevated risk of infertility, endometrial cancer, obesity, diabetes, dyslipidemia and nonalcoholic fatty liver disease (NAFLD). Moreover, there is a paucity of treatments that address the metabolic and reproductive concerns of this disorder. Obstructive sleep apnea (OSA) is a recognized co-morbidity of PCOS that may exacerbate both metabolic and reproductive aspects of PCOS. Thus, treating OSA represents a potentially attractive tool to improve outcomes in PCOS. Indeed, continuous positive airway pressure therapy (CPAP) is a relatively inexpensive treatment for OSA that is safe for use in women in the reproductive years, even when pregnant or trying to conceive. However, evidence regarding the impact of CPAP use in PCOS populations is lacking, and, currently, screening and treatment of OSA is only considered standard of care to treat symptoms of excessive sleepiness or hypertension. Because an estimated 15-45% of people with moderate/severe OSA do not have these symptoms, treatment is not considered standard of care for the majority of persons with OSA and PCOS. From another study looking at sleep and PCOS, we will identify 20 subjects with moderate-to-severe OSA without excessive daytime sleepiness who will enroll in a CPAP trial. These subjects will undergo intensive multi-tissue insulin resistance testing and will be assigned treatment with CPAP or delayed treatment after 12 weeks after which all measures will be re-assessed. Accordingly, this proposal will address an unanswered question: Does CPAP provide metabolic or reproductive benefits in PCOS? The results will also better define potential mechanistic pathways linking OSA to insulin resistance and will determine whether CPAP improves key outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP Group | Active comparator | Device: Continuous Positive Airway Pressure Device (CPAP)Participants randomized to CPAP will initiate CPAP therapy at the beginning of the study. |
| Delayed CPAP Group | Placebo comparator | Other: Delayed Continuous Positive Airway Pressure Device (CPAP)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 Device (CPAP)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. | Device | CPAP Group |
| Delayed Continuous Positive Airway Pressure Device (CPAP)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. | Other | Delayed CPAP Group |
Primary outcome
Number of participants showing a change in fractional de novo lipogenesis (DNL, %)
Time frame: Baseline and 12 weeks
The percent of newly synthesized fatty acids (DNL, %) will be measured using a stable isotope (deuterated water) and mass spectrometry.
Number of participants showing a change in free testosterone (pg/mL)
Time frame: Baseline and 12 weeks
The aim is evaluate the effect of treating OSA with CPAP on biochemical hyperandrogenism in individuals with PCOS.
Number of participants showing a change in insulin secretion rate (picomol/min)
Time frame: Baseline and 12 weeks
Glucose Tolerance Test is used to measure of insulin secretion rate.
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 23 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovary Syndrome
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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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. This study is not recruiting at the moment.
Heather Huddleston, MD principal investigator
University of California, San Francisco
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 Device (CPAP) and Delayed Continuous Positive Airway Pressure Device (CPAP) in people with Polycystic Ovary Syndrome and Obstructive Sleep Apnea, run by University of California, San Francisco 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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants showing a change in fractional de novo lipogenesis (DNL, %) (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. 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 23 Jan 2026.