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

This study is currently recruiting participants.
Verified April 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01719224
First received: October 30, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

The investigators hypothesized that sleeping in a 45 degrees elevated body position decreases the likelihood of upper airway vulnerability to collapse. Furthermore, the investigators want to elucidate the anatomical and physiological risk factors that contribute in the upper airway obstruction in post-partum patients.


Condition Intervention
Sleep Disordered Breathing
Upper Airway Collapsibility
Upper Airway Obstruction
 Procedure: elevated body position
Procedure: supine body position

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Lower rate of sleep disordered breathing in elevated body position [ Time Frame: 48 hours after delivery ] [ Designated as safety issue: Yes ]
    We conduct polysomnography in supine 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:
  • to elucidate the anatomical and physiological risk factors that contribute in the upper airway obstruction in post-partum patients [ Time Frame: 48 hours after delivery ] [ Designated as safety issue: Yes ]
    We measure pulmonary function using spirometry, and have a look at MEF/MIF 50 Ratio, FIV 1, FVC and FEV 1. Furthermore we evaluate risk factors for upper airway dysfunction by using the STOP-Bang-Questionnaire, and Mallampati Scores, as well as anatomical landmarks (measuring inter-incisor gap, thyromental distance, sternomental distance, neck circumference).


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719224

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Matthias Eikermann, MD, PhD     617-643-4408     MEIKERMANN@PARTNERS.ORG    
Principal Investigator: Matthias Eikermann, MD, Ph.D            
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
  More Information

No publications provided

Responsible Party: Matthias Eikermann, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01719224     History of Changes
Other Study ID Numbers: 2011P001326
Study First Received: October 30, 2012
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Airway Obstruction
Respiratory Aspiration
Sleep Apnea Syndromes
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013