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

Trial Summary

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 data supports the effectiveness of CPAP treatment for women with polycystic ovary syndrome (PCOS)?

Research shows that treating obstructive sleep apnea (OSA) with CPAP can improve heart and metabolic health in women with PCOS, who often have OSA and are at risk for diabetes and heart disease. ^{1 2 3 4 5}

Is CPAP generally safe for humans?

CPAP (Continuous Positive Airway Pressure) is generally considered safe for humans, as it is commonly used to treat obstructive sleep apnea, a condition that affects breathing during sleep. Studies have shown that CPAP can improve health outcomes in people with sleep apnea, including those with conditions like polycystic ovary syndrome (PCOS). ^{3 5 6 7 8}

How does CPAP treatment differ from other treatments for polycystic ovary syndrome (PCOS)?

CPAP (Continuous Positive Airway Pressure) treatment is unique for PCOS because it addresses sleep-disordered breathing, which is common in women with PCOS and can worsen metabolic issues. Unlike other treatments that focus directly on hormonal or metabolic symptoms, CPAP improves cardiometabolic function by treating obstructive sleep apnea, a condition often linked with PCOS. ^{1 2 3 5 9}

What is the purpose of this trial?

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.

Research Team

Heather Huddleston, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Alterations in nasal mucociliary activity in polycystic ovary syndrome. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of sleep-disordered breathing on metabolic dysfunctions in patients with polycystic ovary syndrome. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

The prevalence of obstructive sleep apnoea in women with polycystic ovary syndrome: a systematic review and meta-analysis. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Comorbidities in polycystic ovary syndrome: their relationship to insulin resistance. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of obstructive sleep apnea improves cardiometabolic function in young obese women with polycystic ovary syndrome. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Increased risk of obstructive sleep apnoea in women with polycystic ovary syndrome: a population-based cohort study. [2022]

7. New Zealand 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Polycystic Ovarian Syndrome: Impact on Adult and Fetal Health. [2021]

9. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Impaired olfactory function in patients with polycystic ovary syndrome. [2017]