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Poor enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | ||
| Screen for Sleep Apnea | Experimental | Screen for sleep apnea, treat with continuous positive airway pressure (CPAP) if diagnosed with sleep apnea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening for obstructive sleep apnea | Other |
| ||
| CPAP - continuous positive airway pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Ovulatory cycles | 3 months |
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Inclusion Criteria
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.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USF REI Lakeland | Lakeland | Florida | 33805 | United States | ||
| USF REI Sarasota |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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| Device |
|
| 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 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |