Using CPAP to Improve Menstruation in Women With Polycystic Ovarian Syndrome and Obstructive Sleep Apnea
| Status: | Withdrawn |
|---|---|
| Conditions: | Insomnia Sleep Studies, Women's Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 8/5/2018 |
| Start Date: | July 2016 |
| End Date: | August 1, 2018 |
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.
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.
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.
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
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