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Procedure

CPAP for Polycystic Ovary Syndrome

N/A

Recruiting

Led By Heather Huddleston, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects found to have moderate to severe OSA (AHI >15)

Ages 18-40

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 weeks

Awards & highlights

Study Summary

This trial looks at how Polycystic Ovary Syndrome and Obstructive Sleep Apnea may be related, and how treatment with CPAP may improve insulin resistance.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

CPAP devices may cause discomfort such as nasal congestion or dryness, skin irritation from the mask strap, headaches or ear pressure changes. Rarely it can lead to lung infection if not cleaned properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with moderate to severe sleep apnea.

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I am between 18 and 40 years old.

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I have PCOS with high androgen levels and irregular ovulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants showing a change in fractional de novo lipogenesis (DNL, %)

Number of participants showing a change in free testosterone (pg/mL)

Number of participants showing a change in insulin secretion rate (picomol/min)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: CPAP GroupActive Control1 Intervention

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

Group II: Delayed CPAP GroupPlacebo Group1 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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,507 Previous Clinical Trials

15,238,520 Total Patients Enrolled

6 Trials studying Polycystic Ovary Syndrome

205 Patients Enrolled for Polycystic Ovary Syndrome

Heather Huddleston, MDPrincipal InvestigatorUniversity of California, San Francisco

6 Previous Clinical Trials

8,307 Total Patients Enrolled

4 Trials studying Polycystic Ovary Syndrome

127 Patients Enrolled for Polycystic Ovary Syndrome

Media Library

Continuous Positive Airway Pressure Device (CPAP) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05920694 — N/A

Polycystic Ovary Syndrome Research Study Groups: Delayed CPAP Group, CPAP Group

Polycystic Ovary Syndrome Clinical Trial 2023: Continuous Positive Airway Pressure Device (CPAP) Highlights & Side Effects. Trial Name: NCT05920694 — N/A

Continuous Positive Airway Pressure Device (CPAP) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05920694 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research accepting participants who are over the age of 40?

"As specified in the trial guidelines, participants must be within a certain age bracket - 18 to 40 years old."

Answered by AI

Who has the credentials to participate in this experiment?

"Applicants for this clinical trial need to have been diagnosed with polycystic ovary syndrome and must be in between the ages of 18-40. The total capacity is 20 participants."

Answered by AI

Are new participants being accepted for this clinical experiment at the moment?

"Affirmative. Data present on clinicaltrials.gov confirms that this trial, which was initially launched in December 2022, is still actively recruiting volunteers. Currently, the project requires 20 participants to be accepted from a single medical centre."

Answered by AI

What is the maximum capacity for participants in this experiment?

"Affirmative. Clinicaltrials.gov states that this trial is presently welcoming participants. It was first announced on December 22nd 2022 and modified most recently on June 16th 2023. The research necessitates the enrolment of 20 subjects at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Restoring Metabolic and Reproductive Health With Sleep in PCOS Study, CPAP Trial

2022. "Restoring Metabolic and Reproductive Health With Sleep in PCOS Study, CPAP Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05920694.