Summary

Eligibility
for females ages 18-40 (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Heather Huddleston, MD
Headshot of Heather Huddleston
Heather Huddleston

Description

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. 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.

Details

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.

Keywords

Polycystic Ovary Syndrome, Obstructive Sleep Apnea, Continuous Positive Airway Pressure Device (CPAP), Delayed Continuous Positive Airway Pressure Device (CPAP)

Eligibility

You can join if…

Open to females ages 18-40

  • 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

You CAN'T join if...

  • 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)

Location

  • UCSF accepting new patients
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Heather Huddleston, MD
    Dr. Heather Huddleston is a specialist in reproductive endocrinology (hormonal function) and infertility. She cares for patients with a wide array of reproductive and fertility concerns. She has special interests in polycystic ovary syndrome (PCOS), recurrent pregnancy loss and uterine disorders, including Asherman's syndrome (a condition involving scar tissue in the uterus).

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05920694
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated