Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention

Sleep Disordered Breathing Clinical Trial

Official title:

Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719224
• Other study ID #: 2011P001326
• Status: Completed
• Phase: N/A
• First received: October 30, 2012
• Last updated: May 10, 2017
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Postpartum mothers within 48 hours of delivery in a major academic teaching hospital.

2. Age over 18 years.

3. Admitted to the Massachusetts General Hospital OB service for the delivery.

4. Interventions will be randomly assigned to the patients enrolled in this study

Exclusion Criteria:

1. Age under 18 years.

2. 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.

Related Conditions & MeSH terms

• Airway Obstruction
• Respiratory Aspiration
• Sleep Disordered Breathing
• Upper Airway Collapsibility
• Upper Airway Obstruction

Intervention

Procedure:
• elevated body position
45 degrees elevated upper body position
• supine body position
non-elevated upper body position

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep	We conduct polysomnography in non-elevated and 45 degrees elevated body position, to show the effect of body position in context of sleep disordered breathing.We collect data of the apnea-hypopnea-index, central apneas, obstructive apneas and oxygen.	48 hours after delivery
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	Each patient underwent measurements of upper airway 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.	48 hours after delivery