The SNORES Randomized Clinical Trial (SNORES)

May 1, 2017 updated by: University of South Florida

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Lakeland, Florida, United States, 33805
        • USF REI Lakeland
      • Saint Petersburg, Florida, United States, 33701
        • USF REI St. Petersburg
      • Sarasota, Florida, United States, 34239
        • USF REI Sarasota
      • Tampa, Florida, United States, 33606
        • USF South Tampa Center
      • Tampa, Florida, United States, 33612
        • USF Morsani
      • Wesley Chapel, Florida, United States, 33544
        • USF REI Wesley Chapel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ovulatory cycles
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00020545

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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