Study Stopped
Poor enrollment
The SNORES Randomized Clinical Trial
SNORES
Sleep Apnea in Non-ovulating REI Patients: The SNORES Randomized Clinical Trial
1 other identifier
interventional
4
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 13, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 4, 2017
May 1, 2017
1.3 years
April 13, 2015
May 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Ovulatory cycles
3 months
Study Arms (2)
Usual care
NO INTERVENTIONScreen for Sleep Apnea
EXPERIMENTALScreen for sleep apnea, treat with continuous positive airway pressure (CPAP) if diagnosed with sleep apnea
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
USF REI Lakeland
Lakeland, Florida, 33805, United States
USF REI Sarasota
Sarasota, Florida, 34239, United States
USF REI St. Petersburg
St. Petersburg, Florida, 33701, United States
USF South Tampa Center
Tampa, Florida, 33606, United States
USF Morsani
Tampa, Florida, 33612, United States
USF REI Wesley Chapel
Wesley Chapel, Florida, 33544, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2015
First Posted
May 13, 2015
Study Start
January 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
May 4, 2017
Record last verified: 2017-05