The SNORES Randomized Clinical Trial

University of South Florida

Status

Terminated

Conditions

PCOS

Sleep Apnea

Treatments

Other: Screening for obstructive sleep apnea

Device: CPAP - continuous positive airway pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT02442999

Pro00020545

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.