Trials / Completed
CompletedNCT01719224
Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Detailed description
After obtaining study consent, each patient underwent measurements of upper airway cross-sectional area (CSA) during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position. This method has been previously used and validated in pregnant women. In the patients who further gave consent for the sleep study, polysomnography (PSG) was performed throughout the entire study night. Within a crossover design, patients were randomly assigned to receive first either nonelevated or 45° elevated upper body position. Position was changed after 3.5 h by a member of the team.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | elevated body position | 45 degrees elevated upper body position |
| PROCEDURE | supine body position | non-elevated upper body position |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2014-10-01
- Completion
- 2014-12-01
- First posted
- 2012-11-01
- Last updated
- 2017-12-15
- Results posted
- 2017-12-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01719224. Inclusion in this directory is not an endorsement.