ACTIVE_NOT_RECRUITING

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

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Conditions

Polycystic Ovary SyndromeObstructive Sleep Apnea

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-12-22
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05920694

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects found to have moderate to severe OSA (AHI \>15)
  2. * PCOS diagnosis satisfies both the hyperandrogenic and oligo-ovulatory requirements of Rotterdam criteria
  3. * Ages 18-40
  4. * BMI 25-45 kg/m2
  5. * Fasting insulin \>16
  6. * At-risk score on Berlin Questionnaire
  1. * Current use of oral contraceptives
  2. * Diabetes mellitus (fasting glucose ≥126 mg/dL or 2-h glucose ≥200 mg/dL or HGB A1c ≥6.5%)
  3. * Treatment for asthma
  4. * Regular tobacco use or alcohol consumption exceeding 1 drink/day
  5. * HIV infection or infectious hepatitis
  6. * Pregnancy or lactation within the past six months
  7. * Prior OSA treatment
  8. * Excessive daytime sleepiness as defined as \>16 on the Eppworth Sleepiness Scale or untreated or inadequately treated hypertension (\>150/90)

Contacts and Locations

Principal Investigator

Heather Huddleston, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94158
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Heather Huddleston, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-22
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2022-12-22
Study Completion Date2026-07-30

Terms related to this study

Additional Relevant MeSH Terms

  • Polycystic Ovary Syndrome
  • Obstructive Sleep Apnea