Using CPAP to Improve Menstruation in Women With Polycystic Ovarian Syndrome and Obstructive Sleep Apnea

NCT ID: NCT03155828

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-08-01

Brief Summary

The purpose of this study is to determine if treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure in women with both OSA and polycystic ovarian syndrome will improve the regularity of the women's menstrual cycles.

Detailed Description

Women seeking fertility treatment at the University of Louisville will be screened for polycystic ovarian syndrome (PCOS) based on history and then blood work if history suggests PCOS. After establishing a diagnosis of PCOS based on the National Institute of Health criteria, they will be screened for impaired glucose tolerance, Class III obesity, and obstructive sleep apnea [using the Epworth Sleepiness Scale (ESS) as the initial screen]. For those women that screen positive on the ESS, they will be referred to the University of Louisville Physicians Sleep Center for a formal sleep study. Only patients with PCOS, severe obstructive sleep apnea, impaired glucose tolerance, and Class III obesity will qualify for enrollment in the study. Once enrolled, patients will be encouraged to use continuous positive airway pressure (CPAP, standard of care for treatment of obstructive sleep apnea) for at least six months. During those six months, patients will be asked to track their menstrual cycles and whether they took progesterone to induce a withdrawal bleed during that time period. The use of ovulation predictor kits to help determine ovulation status will be encouraged, but not required for the study.

During initial evaluation, patients seeking fertility care having a clinical presentation concerning for PCOS have their blood drawn for evaluation of thyroid stimulating hormone, free and total testosterone, antimullerian hormone, and 2 hour glucose tolerance test. At the conclusion of six months of CPAP therapy, patients will be asked to repeat the above blood tests for comparison to baseline values.

Women can continue to attempt pregnancy during the study time period if they desire.

Conditions

Sleep Apnea, Obstructive; Anovulation; Polycystic Ovarian Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

CPAP

Women with diagnosed obstructive sleep apnea will be treated using continuous positive airway pressure as per standard of care.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18-35
• English speakers
• Polycystic ovarian syndrome by NIH criteria
• Abnormal 2 hour glucose tolerance test
• Body mass index >/= 40 kg/m2
• Severe obstructive sleep apnea diagnosed with either a home or in-house sleep study

Exclusion Criteria

• Age <18 or >35
• Non English speakers
• No diagnosis of PCOS
• Normal glucose tolerance test
• No diagnosis of obstructive sleep apnea
• Body mass index < 40 kg/m2
• Using any form of hormonal contraception

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Kelly Pagidas

Professor, Obstetrics and Gynecology and Women's Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelly Pagidas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville Fertility Center

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

16.0388

Identifier Type: -

Identifier Source: org_study_id