N/A
N=36
Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention
Sleep Disordered Breathing · Upper Airway Collapsibility · Upper Airway Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT01719224 ↗Enrolled (actual)
36
Serious AEs
—
Results posted
Dec 2017
Primary outcome: Primary: Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep — 4.5; 7.7 Apneas and hypopneas per hour of sleep
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- elevated body position (Procedure); supine body position (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep |
4.5; 7.7 | — |
| SECONDARY Minimum Upper Airway Cross-sectional Area: to Elucidate the Anatomical and Physiological Risk Factors That Contribute to the Upper Airway Obstruction in Post-partum Patients |
1.54; 1.35; 1.46 | — |
Summary
The investigators hypothesized that sleeping in a 45 degrees elevated body position decreases the likelihood of upper airway vulnerability to collapse early after delivery. Furthermore, the investigators want to elucidate the anatomical and physiological risk factors that contribute in the upper airway obstruction in post-partum patients.
Eligibility Criteria
Inclusion Criteria
- Postpartum mothers within 48 hours of delivery in a major academic teaching hospital.
- Age over 18 years.
- Admitted to the Massachusetts General Hospital OB service for the delivery.
- Interventions will be randomly assigned to the patients enrolled in this study
Exclusion Criteria
- Age under 18 years.
- History of pre-existing pulmonary and cardiac diseases, including bronchial asthma, cystic fibrosis, chronic obstructive lung disease, neck and chest tumors (thyroid, mediastinal, etc.), irradiation to the neck and/or chest, and congenital airway deformities, other critically-ill conditions.
Data sourced from ClinicalTrials.gov (NCT01719224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.