The SNORES Randomized Clinical Trial

Sleep Apnea Clinical Trial

— SNORES  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02442999
• Other study ID #: Pro00020545
• Status: Terminated
• Phase: N/A
• First received: April 13, 2015
• Last updated: May 1, 2017
• Start date: January 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• PCOS
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Other:
• Screening for obstructive sleep apnea

Device:
• CPAP - continuous positive airway pressure

Locations

Country	Name	City	State
United States	USF REI Lakeland	Lakeland	Florida
United States	USF REI St. Petersburg	Saint Petersburg	Florida
United States	USF REI Sarasota	Sarasota	Florida
United States	USF Morsani	Tampa	Florida
United States	USF South Tampa Center	Tampa	Florida
United States	USF REI Wesley Chapel	Wesley Chapel	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulatory cycles		3 months