The SNORES Randomized Clinical Trial

Not Applicable

Terminated

• Conditions: PCOS; Sleep Apnea
• Interventions: Other: Screening for obstructive sleep apnea; Device: CPAP - continuous positive airway pressure

• Registration Number: NCT02442999
• Lead Sponsor: University of South Florida

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.

Study Timeline

• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-13
• Study Start: 2016-01
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screen for Sleep Apnea	CPAP - continuous positive airway pressure	Screen for sleep apnea, treat with continuous positive airway pressure (CPAP) if diagnosed with sleep apnea
Screen for Sleep Apnea	Screening for obstructive sleep apnea	Screen for sleep apnea, treat with continuous positive airway pressure (CPAP) if diagnosed with sleep apnea

Primary Outcome Measures

Name	Time	Method
Ovulatory cycles	3 months

Trial Locations

Locations (6)

USF REI Sarasota; 🇺🇸 Sarasota, Florida, United States

USF REI St. Petersburg; 🇺🇸 Saint Petersburg, Florida, United States

USF REI Lakeland; 🇺🇸 Lakeland, Florida, United States

USF South Tampa Center; 🇺🇸 Tampa, Florida, United States

USF Morsani; 🇺🇸 Tampa, Florida, United States

USF REI Wesley Chapel; 🇺🇸 Wesley Chapel, Florida, United States