CPAP for Polycystic Ovary Syndrome

Overseen By Jacob Christ, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Oral contraceptives, Asthma treatment

Disqualifiers: Diabetes, Tobacco, Alcohol, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how using a CPAP (Continuous Positive Airway Pressure) device might help women with both Polycystic Ovary Syndrome (PCOS) and Obstructive Sleep Apnea (OSA) manage insulin resistance. Insulin resistance can hinder the body's ability to use insulin properly, often leading to higher blood sugar levels. Researchers aim to determine if improving nighttime oxygen levels with CPAP can reduce insulin resistance. Participants will either begin CPAP treatment immediately or after a 12-week wait. Women with both PCOS and moderate to severe sleep apnea, who do not currently use treatments like oral contraceptives, may be eligible to join. As an unphased trial, this study offers a unique opportunity to contribute to understanding how CPAP might improve health outcomes for women with PCOS and OSA.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using oral contraceptives or being treated for asthma.

What prior data suggests that the CPAP device is safe for treating obstructive sleep apnea in individuals with polycystic ovary syndrome?

Research has shown that continuous positive airway pressure (CPAP) is generally safe for people. CPAP is a common treatment for obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. Studies have found that CPAP is not only safe but also effective in improving health issues related to OSA. For example, people using CPAP often experience better control of their blood sugar levels.

CPAP is widely used and considered safe, especially for women with OSA. It helps reduce sleepiness and other symptoms of OSA. While some people might find it uncomfortable at first, most adjust over time. No major safety concerns have been reported, making it a reliable choice for treating sleep apnea. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using CPAP for Polycystic Ovary Syndrome (PCOS) because it offers a novel approach by addressing obstructive sleep apnea (OSA), which is often linked with PCOS. Unlike standard PCOS treatments that focus on hormone regulation and insulin sensitization, CPAP targets improved breathing during sleep, potentially enhancing insulin resistance. This method could provide a dual benefit for women with PCOS by improving sleep quality and metabolic health simultaneously, making it a unique and promising addition to existing therapies.

What evidence suggests that CPAP is effective for improving insulin resistance in people with PCOS?

Research shows that using a Continuous Positive Airway Pressure (CPAP) device can improve insulin resistance in people with Polycystic Ovary Syndrome (PCOS) who also have obstructive sleep apnea (OSA). In this trial, participants will be randomized into two groups: one group will begin CPAP therapy at the start, while the other will start after a 12-week delay. Studies have found that CPAP increases insulin sensitivity, lowers blood pressure, and reduces inflammation. In young women with PCOS, CPAP use has been linked to better insulin response and less stress on the heart. CPAP is considered the best treatment for breathing problems during sleep, as it provides a steady airflow to keep the airway open. This treatment could be a promising way to improve both metabolic and reproductive health in women with PCOS. ^{1 2 6 7 8}

Who Is on the Research Team?

Heather Huddleston, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults aged 18-40 with Polycystic Ovary Syndrome (PCOS) and moderate to severe Obstructive Sleep Apnea (OSA). Participants should have a BMI of 25-45, high fasting insulin levels, and meet specific PCOS criteria. Pregnant or breastfeeding individuals, those with untreated hypertension, HIV/hepatitis, asthma treatment, tobacco/alcohol use, prior OSA treatment or diabetes are excluded.

Inclusion Criteria

I have been diagnosed with moderate to severe sleep apnea.

Your body mass index (BMI) is between 25 and 45.

I have PCOS with high androgen levels and irregular ovulation.

Exclusion Criteria

I am receiving treatment for asthma.

I have diabetes with high blood sugar levels.

I am currently using oral contraceptives.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CPAP therapy or are placed in a delayed CPAP group for 12 weeks

12 weeks

Initial visit for CPAP setup, follow-up visits as needed

Follow-up

Participants are monitored for changes in insulin resistance and other metabolic markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Positive Airway Pressure Device (CPAP)
• Delayed Continuous Positive Airway Pressure Device (CPAP)

Trial Overview The study is examining the effects of two types of CPAP devices on metabolic and reproductive health in people with PCOS and OSA. It aims to understand how treating low blood oxygen at night affects insulin resistance.

How Is the Trial Designed?

Group I: CPAP Group Active Control 1 Intervention

Participants randomized to CPAP will initiate CPAP therapy at the beginning of the study.

Group II: Delayed CPAP Group Placebo Group 1 Intervention

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.

Continuous Positive Airway Pressure Device (CPAP) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Continuous Positive Airway Pressure Device for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)

Approved in European Union as CPAP Device for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)

Approved in Canada as Continuous Positive Airway Pressure Device for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)

Approved in Japan as CPAP Machine for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

In a study of 25,389 patients with obstructive sleep apnea (OSA), continuous positive airway pressure (CPAP) treatment was linked to a significant reduction in all-cause mortality in middle-aged and elderly males, with a hazard ratio of 0.62 (P<0.001).

While CPAP improved survival rates in older males, it did not show a significant effect on mortality in female patients, indicating a gender difference in the efficacy of CPAP treatment for OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All-cause mortality from obstructive sleep apnea in male and female patients with and without continuous positive airway pressure treatment: a registry study with 10 years of follow-up. Jennum, P., Tønnesen, P., Ibsen, R., et al.[2022]

About 35% of women with polycystic ovary syndrome (PCOS) were found to have obstructive sleep apnoea (OSA), indicating a significant health concern for this population based on a meta-analysis of 17 studies involving 648 participants.

The prevalence of OSA was notably higher in obese women with PCOS compared to lean women, and women with PCOS had a threefold increased risk of OSA compared to controls, highlighting the need for clinicians to be vigilant in screening for OSA in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of obstructive sleep apnoea in women with polycystic ovary syndrome: a systematic review and meta-analysis. Kahal, H., Kyrou, I., Uthman, OA., et al.[2021]

In a study of 50 women with polycystic ovary syndrome (PCOS), 66% were found to have sleep-disordered breathing (SDB), which was linked to significantly higher blood pressure, fasting blood sugar, triglyceride levels, and lower HDL cholesterol, indicating increased metabolic risks.

Women with PCOS and SDB also exhibited more severe hyperandrogenism and excessive daytime sleepiness, suggesting that SDB may be an independent risk factor for metabolic dysfunctions in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of sleep-disordered breathing on metabolic dysfunctions in patients with polycystic ovary syndrome. Chatterjee, B., Suri, J., Suri, JC., et al.[2017]

Women with polycystic ovary syndrome (PCOS) showed significantly impaired olfactory function compared to healthy controls, as measured by the Sniffin' sticks test, indicating a potential sensory deficit associated with the condition.

The study found a correlation between olfactory dysfunction and higher levels of depressive symptoms in PCOS patients, suggesting that these sensory impairments may be linked to the mental health challenges faced by these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impaired olfactory function in patients with polycystic ovary syndrome. Koseoglu, SB., Koseoglu, S., Deveer, R., et al.[2017]

Women with polycystic ovary syndrome (PCOS) have significantly longer nasal mucociliary clearance times (NMCT) compared to control subjects, with averages of 10.45 minutes versus 6.92 minutes, indicating a potential respiratory issue associated with the condition.

The study found that longer NMCT in PCOS patients correlates with higher levels of testosterone and luteinizing hormone, suggesting that hormonal imbalances in PCOS may contribute to respiratory complications, increasing the risk of infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alterations in nasal mucociliary activity in polycystic ovary syndrome. Kabil Kucur, S., Seven, A., Yuksel, B., et al.[2018]

Polycystic ovary syndrome (PCOS) affects 5-10% of women of child-bearing age and is associated with increased risks for type 2 diabetes, cardiovascular disease, and obstructive sleep apnea due to insulin resistance.

It is crucial for women with PCOS to undergo aggressive screening for glucose intolerance and cardiovascular risk factors, as well as screening for sleep apnea when symptoms are present, to prevent these serious health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbidities in polycystic ovary syndrome: their relationship to insulin resistance. Bethea, SW., Nestler, JE.[2017]

Women with polycystic ovary syndrome (PCOS) are significantly more likely to develop obstructive sleep apnoea (OSA), with a hazard ratio of 2.26, indicating more than double the risk compared to women without PCOS, regardless of their weight status.

The study analyzed data from 76,978 women with PCOS and 143,077 matched controls over a median follow-up of 3.5 years, highlighting the importance of screening for OSA in women with PCOS due to the associated health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased risk of obstructive sleep apnoea in women with polycystic ovary syndrome: a population-based cohort study. Kumarendran, B., Sumilo, D., O'Reilly, MW., et al.[2022]

Continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA) in young obese women with polycystic ovary syndrome (PCOS) significantly improved insulin sensitivity after 8 weeks, with better results linked to increased CPAP usage.

CPAP treatment also led to a reduction in daytime diastolic blood pressure and decreased sympathetic nervous system activity, indicating potential cardiometabolic benefits for women with PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of obstructive sleep apnea improves cardiometabolic function in young obese women with polycystic ovary syndrome. Tasali, E., Chapotot, F., Leproult, R., et al.[2021]

Women with polycystic ovarian syndrome (PCOS) face a higher risk of pregnancy complications such as miscarriage, gestational diabetes, and hypertensive disorders, highlighting the need for careful monitoring during pregnancy.

PCOS is linked to several long-term health issues beyond fertility, including type II diabetes, cardiovascular disease, and mental health disorders, emphasizing the importance of early identification and management of associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polycystic Ovarian Syndrome: Impact on Adult and Fetal Health. Martini, AE., Healy, MW.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11377251/

Polycystic ovary syndrome in obstructive sleep apnea ... Research has demonstrated that continuous positive airway pressure (CPAP) can ameliorate IR, mitigate OS and inflammatory status, and enhance ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00203996?cond=Cancer&intr=thiazolidinediones&rank=7

Polycystic Ovary Syndrome (PCOS) and Sleep Apnea CPAP is the most effective treatment available for sleep disordered breathing. CPAP provides a constant, controllable pressure to keep your upper airway open ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3048326/

Treatment of Obstructive Sleep Apnea Improves ... In young obese women with PCOS, successful treatment of OSA improves insulin sensitivity, decreases sympathetic output, and reduces diastolic blood pressure.

4. withpower.com withpower.com/trial/phase-polycystic-ovary-syndrome-11-2022-d5239

CPAP for Polycystic Ovary Syndrome In a study of 25,389 patients with obstructive sleep apnea (OSA), continuous positive airway pressure (CPAP) treatment was linked to a significant reduction in ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05920694

Restoring Metabolic and Reproductive Health With Sleep ... Thus, treating OSA represents a potentially attractive tool to improve outcomes in PCOS. Indeed, continuous positive airway pressure therapy ( ...

6. careacross.com careacross.com/clinical-trials/trial/NCT05920694

Restoring Metabolic and Reproductive Health With Sleep ... Indeed, continuous positive airway pressure therapy (CPAP) is a relatively inexpensive treatment for OSA that is safe for use in women in the reproductive ...

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/sleep-apnea

UCSF Sleep Apnea Clinical Trials — San Francisco Bay Area A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure ...

8. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.7638

Treatment of Adult Obstructive Sleep Apnea With Positive ... PAP compared to no treatment results in a clinically significant reduction in disease severity, sleepiness, blood pressure, and motor vehicle accidents.