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Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by David Andrew Wellman, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01733784
First Posted: November 27, 2012
Last Update Posted: September 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital
  Purpose
In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The investigators will assess the viscoelastic properties of the pharyngeal airway and its role in PEN.

Condition Intervention
Sleep Apnea Other: Induced central apneas

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D

Resource links provided by NLM:


Further study details as provided by David Andrew Wellman, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Upper airway elasticity [ Time Frame: 10 - 40 seconds ]

    The investigators will determine elasticity of the upper airway during induced central apneas by dividing the change in airway pressure by the change in airway cross-sectional area.

    The time frame for the outcome of this study is equal to the duration of the induced central sleep apnea (usually less than 40 seconds).



Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Viscoelastic properties of the airway Other: Induced central apneas

Detailed Description:

In obstructive sleep apnea, the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea.

The investigators will test how the viscoelastic properties of the airway influence PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients using a thin endoscope and will induce central apneas during sleep. Pharyngeal cross-sectional area will be recorded during incremental changes in pharyngeal pressure during central apneas.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Normal subjects or patients with OSA

Exclusion Criteria:

  • Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
  • Any medication known to influence breathing, sleep/arousal or muscle physiology
  • Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
  • Claustrophobia
  • Inability to sleep supine
  • Allergy to lidocaine or oxymetazoline hydrochloride
  • For women: Pregnancy
  Contacts and Locations
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): NCT01733784


Contacts
Contact: Pedro R Genta, MD (617) 732-6541 pgenta@partners.org
Contact: Lauren B Hess, BS (617) 732-8976 lhess1@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Pedro R Genta, MD    617-732-6541    pgenta@partners.org   
Contact: Lauren B Hess, BS    (617) 732-8976    lhess1@partners.org   
Sub-Investigator: Pedro R Genta, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: David A Wellman, MD Brigham and Women's Hospital
  More Information

Responsible Party: David Andrew Wellman, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01733784     History of Changes
Other Study ID Numbers: 2012P000957D
1R01HL102321-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 14, 2012
First Posted: November 27, 2012
Last Update Posted: September 26, 2013
Last Verified: September 2013

Keywords provided by David Andrew Wellman, Brigham and Women's Hospital:
Sleep Apnea
Pathophysiology

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