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

N/ACompletedNCT01719224

Massachusetts General Hospital55 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sleep Disordered Breathing Upper Airway Collapsibility Upper Airway Obstruction

Interventions

elevated body positionPROCEDURE

45 degrees elevated upper body position

supine body positionPROCEDURE

non-elevated upper body position

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 48 hours after delivery

Secondary Outcomes

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.

Time frame: 48 hours after delivery

Data from ClinicalTrials.gov

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