The SNORES Randomized Clinical Trial



Status:Recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 35
Updated:4/21/2016
Start Date:January 2016
End Date:August 2019
Contact:Judette M Louis, MD, MPH
Email:jlouis1@health.usf.edu

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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.

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.

Inclusion Criteria

- Females 18 - 35 years old.

- Receiving care at University of South Florida

- 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.
We found this trial at
6
sites
St. Petersburg, Florida 33701
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Lakeland, Florida 33805
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Lakeland, FL
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Sarasota, Florida 34239
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Sarasota, FL
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Tampa, Florida 33606
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Tampa, FL
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Tampa, Florida 33612
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Tampa, FL
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Wesley Chapel, Florida 33544
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Wesley Chapel, FL
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