PCOS, Sleep Apnea
Conditions
Brief summary
Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for fertility treatment to evaluate the impact of screening for obstructive sleep apnea.
Detailed description
The investigators' goal is to perform a randomized clinical trial among women with PCOS who present for infertility treatment. Our primary outcome is to determine if screening women with PCOS, and treating those with confirmed sleep apnea, will lead to more ovulatory cycles. Our sub-aims are to describe the rate of OSA and sleep symptoms in patients with PCOS, to see if current sleep questionnaires correlate to a diagnostic sleep study, to describe the correlation between OSA and biomarkers of glucose homeostasis in women with PCOS, to investigate health related quality of life between the groups, to compare perinatal outcomes between the groups, and to evaluate the composition of breastmilk among women who choose to breastfeed.
Interventions
DEVICECPAP - continuous positive airway pressure
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Females 18 - 50 years old. * Receiving care from an Obstetrician / gynecologist or a Reproductive endocrinology infertility specialist * Polycystic ovarian syndrome defined by the modified Rotterdam criteria * Able to speak and understand as well as give informed consent in English
Exclusion criteria
* Late onset congenital adrenal hyperplasia * Cushings disease * Androgen-secreting tumors * Previous diagnosis of obstructive sleep apnea * Current use of over the counter or prescribed sleep medications. * Examples of medications that exclude a patient from this study include but are not limited to Unisom, Ambien or Lunesta. * Patients who are taking non-prescribed herbal medications for sleep will not be excluded from the study. Examples of these include but are not limited to melatonin, chamomile, or valerian. * Untreated thyroid disease * Prolactin excess * Patients with the following medical conditions will be excluded from the study as portable sleep apnea monitors are not indicated in patients with severe pulmonary disease, neuromuscular disease, or congestive heart failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ovulatory cycles | 3 months |
Countries
United States
Outcome results
None listed