The SNORES Randomized Clinical Trial

Study Overview
=================
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.

Official Title
-----------------
Sleep Apnea in Non-ovulating REI Patients: The SNORES Randomized Clinical Trial

Conditions
-----------------
PCOS, Sleep Apnea

Intervention / Treatment
-----------------
* Other: Screening for obstructive sleep apnea
* Device: CPAP - continuous positive airway pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br> | |
| Experimental: Screen for Sleep Apnea<br>Screen for sleep apnea, treat with continuous positive airway pressure (CPAP) if diagnosed with sleep apnea | Other: Screening for obstructive sleep apnea<br> <br> Device: CPAP - continuous positive airway pressure<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulatory cycles |  | 3 months |