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

August 1, 2018 updated by: Kelly Pagidas, University of Louisville

A Novel Method of Restoring Menstrual Cyclicity or Ovulatory Function in PCOS Patients: The Use of CPAP to Improve More Than Sleep Quality

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.

Study Overview

Status

Withdrawn

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • University of Louisville Fertility Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women seeking fertility treatment at the University of Louisville Reproductive Endocrinology and Infertility Center who have diagnosed polycystic ovarian syndrome, glucose intolerance, obesity, and obstructive sleep apnea.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual Cyclicity
Time Frame: 6 months
Resumption of regular cycles as evaluated either by paper menstrual calendar or use of a menstrual cycle application on smart phone or tablet.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulation
Time Frame: 6 months
Resumption of ovulatory cycles as evaluated by positive ovulation predictor kits.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kelly Pagidas, MD, University of Louisville

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 Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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