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

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ClinicalTrials.gov Identifier: NCT03155828
Recruitment Status : Enrolling by invitation
First Posted : May 16, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Kelly Pagidas, University of Louisville

May 11, 2017
May 16, 2017
October 25, 2017
July 2016
June 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03155828 on ClinicalTrials.gov Archive Site
Ovulation [ Time Frame: 6 months ]
Resumption of ovulatory cycles as evaluated by positive ovulation predictor kits.
Same as current
Not Provided
Not Provided
 
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
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
  • Sleep Apnea, Obstructive
  • Anovulation
  • Polycystic Ovarian Syndrome
Device: CPAP
Women with diagnosed obstructive sleep apnea will be treated using continuous positive airway pressure as per standard of care.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
5
Same as current
June 2018
June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03155828
16.0388
No
Not Provided
Plan to Share IPD: No
Kelly Pagidas, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Kelly Pagidas, MD University of Louisville
University of Louisville
October 2017