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

NCT03155828 | Withdrawn

• 1 other identifier: 16.0388
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive; Anovulation; Polycystic Ovarian Syndrome

Keywords

PCOS, OSA, CPAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ovulation

  6 months

Interventions

CPAP DEVICE

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Fertility Center

Louisville, Kentucky, 40205, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Anovulation; Polycystic Ovary Syndrome; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Ovarian Cysts; Cysts; Neoplasms

Study Officials

• Kelly Pagidas, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Obstetrics and Gynecology and Women's Health

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 16, 2017
• Study Start: July 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)