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OpenTrials
Completed

NCT Number: NCT01719224

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

elevated body position

Procedure

45 degrees elevated upper body position

supine body position

Procedure

non-elevated upper body position

Primary outcomes

  1. Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep

    Time frame: 48 hours after delivery

    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.

Secondary outcomes

  1. 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

    Time frame: 48 hours after delivery

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 1, 2012
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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