Clinical Trials Directory

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

TypeNameDescription
PROCEDUREelevated body position45 degrees elevated upper body position
PROCEDUREsupine body positionnon-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.