Clinical trial NCT02442999: The SNORES Randomized Clinical Trial
Official title: Sleep Apnea in Non-ovulating REI Patients: The SNORES Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PCOS
Sleep Apnea
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Ovulatory cycles
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lakeland
country: United States
facility: USF REI Lakeland
state: Florida
city: Saint Petersburg
country: United States
facility: USF REI St. Petersburg
state: Florida
city: Sarasota
country: United States
facility: USF REI Sarasota
state: Florida
city: Tampa
country: United States
facility: USF South Tampa Center
state: Florida
city: Tampa
country: United States
facility: USF Morsani
state: Florida
city: Wesley Chapel
country: United States
facility: USF REI Wesley Chapel
state: Florida
Study officials:
References: