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

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ClinicalTrials.gov Identifier: NCT01719224
Recruitment Status : Completed
First Posted : November 1, 2012
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Upper Airway Collapsibility Upper Airway Obstruction Procedure: elevated body position Procedure: supine body position Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention
Study Start Date : March 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Elevated body position
We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.
Procedure: elevated body position
45 degrees elevated upper body position
Active Comparator: supine body position
We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.
Procedure: supine body position
non-elevated upper body position



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719224


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Matthias Eikermann, MD, Ph.D Massachusetts General Hospital Department of Anesthesia, Critical Care and Pain Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthias Eikermann, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01719224     History of Changes
Other Study ID Numbers: 2011P001326
First Posted: November 1, 2012    Key Record Dates
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Respiratory Aspiration
Airway Obstruction
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Respiratory Insufficiency