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| Name | Class |
|---|---|
| Brown University | OTHER |
| Rhode Island Hospital | OTHER |
| Women and Infants Hospital of Rhode Island | OTHER |
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This study seeks to understand the physical, physiologic and biologic features that predispose a woman to the development of obstructive sleep apnea once they are exposed to the cardiopulmonary and metabolic physiological changes of pregnancy. Knowing these specific predictive factors can help identify a population at risk and guide clinicians to develop suitable targeting screening strategies.
Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will have:
Women without sleep apnea at enrollment will then be followed longitudinally for the development of obstructive sleep apnea during pregnancy with repeat assessment during their third trimester. Women diagnosed with sleep apnea at enrollment will have no further assessment in late pregnancy.
Monetary incentives will also be issued at data collection points. Subjects will receive small gift incentives such as baby-related items.
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| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of participants who develop obstructive sleep apnea defined as an apnea hypopnea index >5 events per hour | The study will develop a model of biologic, physiologic and anthropometric measures that predict the development of obstructive sleep apnea apnea later in pregnancy compared to baseline in early pregnancy. | Up to 40 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women, 18 years or older, at less than 13 completed weeks of gestation and who have a BMI that is greater than 30 kg/m2 at recruitment.
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| Name | Affiliation | Role |
|---|---|---|
| Ghada Bourjeily, MD | The Miriam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36464928 | Derived | Bublitz MH, Nillni Y, Nugent NR, Sanapo L, Habr N, Bourjeily G. Posttraumatic stress disorder, diurnal cortisol, and ambulatory blood pressure in early and late pregnancy. J Trauma Stress. 2023 Feb;36(1):239-246. doi: 10.1002/jts.22895. Epub 2022 Dec 4. | |
| 34999843 | Derived | Sanapo L, Bublitz MH, Bai A, Mehta N, Messerlian GM, Catalano P, Bourjeily G. Association between sleep disordered breathing in early pregnancy and glucose metabolism. Sleep. 2022 Apr 11;45(4):zsab281. doi: 10.1093/sleep/zsab281. |
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De-identified data for primary and secondary outcome measures will be made available.
Data will be available within 12 months of study completion.
Investigators data access requests will be reviewed by an independent review committee. Requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Blood samples will be stored for future testing
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |