Trials Sponsors Conditions Drugs Pricing

Conditions

Obstructive Sleep Apnea Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

Number of participants showing a change in fractional de novo lipogenesis (DNL, %)
The percent of newly synthesized fatty acids (DNL, %) will be measured using a stable isotope (deuterated water) and mass spectrometry.
Baseline and 12 weeks
Number of participants showing a change in free testosterone (pg/mL)
The aim is evaluate the effect of treating OSA with CPAP on biochemical hyperandrogenism in individuals with PCOS.
Baseline and 12 weeks
Number of participants showing a change in insulin secretion rate (picomol/min)
Glucose Tolerance Test is used to measure of insulin secretion rate.
Baseline and 12 weeks

Study Arms (2)

CPAP Group

ACTIVE COMPARATOR

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

Device: Continuous Positive Airway Pressure Device (CPAP)

Delayed CPAP Group

PLACEBO COMPARATOR

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.

Other: Delayed Continuous Positive Airway Pressure Device (CPAP)

Interventions

Continuous Positive Airway Pressure Device (CPAP)Device

Metabolic studies will be performed before and after initiation of CPAP therapy, which is currently the first-line standard of care for treatment of patients with OSA, both with and without hypoxia.

CPAP Group

Delayed Continuous Positive Airway Pressure Device (CPAP)Other

Metabolic studies will be performed before and after the study period of 12 weeks. After 12 weeks, participants will immediate receive CPAP therapy, which is currently the first-line standard of care for treatment of patients with OSA, both with and without hypoxia.

Eligibility Criteria

Age18 Years - 40 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Subjects found to have moderate to severe OSA (AHI \>15)
PCOS diagnosis satisfies both the hyperandrogenic and oligo-ovulatory requirements of Rotterdam criteria

Sponsors & Collaborators

University of California, San Francisco
Otherlead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

MeSH Terms

Conditions

Polycystic Ovary SyndromeSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesSleep Apnea Syndromes

Study Officials

Heather Huddleston, MD
University of California, San Francisco
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 27, 2023

Study Start

December 22, 2022

Actual (reported)

Primary Completion

July 30, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

CPAP Group

Delayed CPAP Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

CPAP Group

Delayed CPAP Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations