Skip to content

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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03155828
Enrollment
0
Registered
2017-05-16
Start date
2016-07-31
Completion date
2018-08-01
Last updated
2018-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anovulation, Polycystic Ovarian Syndrome, Sleep Apnea, Obstructive

Keywords

PCOS, OSA, CPAP

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.

Interventions

DEVICECPAP

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

Sponsors

University of Louisville
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Menstrual Cyclicity6 monthsResumption of regular cycles as evaluated either by paper menstrual calendar or use of a menstrual cycle application on smart phone or tablet.

Secondary

MeasureTime frameDescription
Ovulation6 monthsResumption of ovulatory cycles as evaluated by positive ovulation predictor kits.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026