NCT02442999

The SNORES Randomized Clinical Trial

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• PCOS
• Sleep Apnea

Interventions

Type	Name	Description
OTHER	Screening for obstructive sleep apnea
DEVICE	CPAP - continuous positive airway pressure

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2015-05-13
• Last updated: 2017-05-04

Locations

6 sites across 1 country: United States