search
Back to results

The SNORES Randomized Clinical Trial (SNORES)

Primary Purpose

PCOS, Sleep Apnea

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening for obstructive sleep apnea
CPAP - continuous positive airway pressure
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • USF REI Lakeland
  • USF REI St. Petersburg
  • USF REI Sarasota
  • USF South Tampa Center
  • USF Morsani
  • USF REI Wesley Chapel

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Screen for Sleep Apnea

Arm Description

Screen for sleep apnea, treat with continuous positive airway pressure (CPAP) if diagnosed with sleep apnea

Outcomes

Primary Outcome Measures

Ovulatory cycles

Secondary Outcome Measures

Full Information

First Posted
April 13, 2015
Last Updated
May 1, 2017
Sponsor
University of South Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT02442999
Brief Title
The SNORES Randomized Clinical Trial
Acronym
SNORES
Official Title
Sleep Apnea in Non-ovulating REI Patients: The SNORES Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS, Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Title
Screen for Sleep Apnea
Arm Type
Experimental
Arm Description
Screen for sleep apnea, treat with continuous positive airway pressure (CPAP) if diagnosed with sleep apnea
Intervention Type
Other
Intervention Name(s)
Screening for obstructive sleep apnea
Intervention Type
Device
Intervention Name(s)
CPAP - continuous positive airway pressure
Primary Outcome Measure Information:
Title
Ovulatory cycles
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
USF REI Lakeland
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
USF REI St. Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
USF REI Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
USF South Tampa Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
USF Morsani
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
USF REI Wesley Chapel
City
Wesley Chapel
State/Province
Florida
ZIP/Postal Code
33544
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The SNORES Randomized Clinical Trial

We'll reach out to this number within 24 hrs