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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03155828
• Other study ID #: 16.0388
• Status: Withdrawn
• Start date: July 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anovulation
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	University of Louisville Fertility Center	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual Cyclicity	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	Ovulation	Resumption of ovulatory cycles as evaluated by positive ovulation predictor kits.	6 months