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Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B

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ClinicalTrials.gov Identifier: NCT01738009
Recruitment Status : Recruiting
First Posted : November 30, 2012
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

Brief Summary:
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 cause of PEN is unknown. The investigators will test if lung volumes and low respiratory drive play a role in PEN.

Condition or disease Intervention/treatment Phase
Sleep Apnea Other: Induction of flow limitation Not Applicable

Detailed Description:

The mechanisms that lead to airway closure in OSA 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 if lung volumes and low respiratory drive play a role in PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients during sleep using a thin endoscope during sleep while simultaneously measuring lung volumes, genioglossus electromyogram, and pharyngeal pressure during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B
Actual Study Start Date : December 8, 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Induction of flow limitation
Flow limitation will be induced by sustained reductions in continuous positive airway pressure during sleep
Other: Induction of flow limitation



Primary Outcome Measures :
  1. Difference in peak inspiratory flow [ Time Frame: 3 minutes ]

    Measured peak inspiratory flow will be compared to predicted peak inspiratory flow during flow restricted breaths.

    The time frame for the outcome will be the duration of induced flow limitation (3 minutes each) . Flow limitation will be induced several times during the night. Flow limited breaths will be averaged.




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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 hydroclhoride
  • For women: Pregnancy

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): NCT01738009


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

Locations
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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
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Principal Investigator: David A Wellman, MD Brigham and Women's Hospital

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Responsible Party: David Andrew Wellman, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01738009     History of Changes
Other Study ID Numbers: 2012P000957B
1R01HL102321-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Keywords provided by David Andrew Wellman, Brigham and Women's Hospital:
Sleep Apnea
Pathophysiology
Additional relevant MeSH terms:
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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