The SNORES Randomized Clinical Trial

University of South Florida4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

PCOS Sleep Apnea

Interventions

Screening for obstructive sleep apneaOTHER

CPAP - continuous positive airway pressureDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

USF REI Lakeland

Lakeland, Florida, United States

USF REI Sarasota

Sarasota, Florida, United States

USF REI St. Petersburg

St. Petersburg, Florida, United States

USF South Tampa Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

Ovulatory cycles

Time frame: 3 months

Data from ClinicalTrials.gov

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