An observational study in Obstructive Sleep Apnea, Pregnancy and Obesity, sponsored by The Miriam Hospital. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by The Miriam Hospital · Observational
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.
1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's planned enrollment of 450 is above the median of 106 across 386 observational studies indexed under Apnea.
Browse Apnea studies →The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Time frame: Up to 40 weeks
Plan to share: Yes — De-identified data for primary and secondary outcome measures will be made available.
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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The Miriam Hospital