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Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study A

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:
NCT01728974
First Posted: November 20, 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, the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. While the airway of some people narrows and airflow decreases during inspiration due to increasing inspiratory effort, others maintain constant airflow throughout inspiration. Airway neuromuscular reflexes may protect against airway narrowing that occurs due to increasing inspiratory effort. To test this hypothesis, the investigators will initially measure airway neuromuscular reflex and inspiratory flow and then attenuate neuromuscular reflex through topical pharyngeal anesthesia to observe the effects on inspiratory flow.

Condition Intervention
Obstructive Sleep Apnea Pathophysiology Other: Pharyngeal topical anesthesia

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Negative effort dependence variation [ Time Frame: After pharyngeal topical anesthesia ]
    The magnitude of negative effort dependence will be expressed as the percent decrease in inspiratory flow from Vmax. NED will be compared before and after topical upper airway anesthesia


Estimated Enrollment: 20
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: Pharyngeal topical anesthesia
Pharyngeal topical anesthesia will be performed using 4% lidocaine spray
Other: Pharyngeal topical anesthesia
Pharyngeal topical anesthesia will be performed using 4% lidocaine spray

Detailed Description:

The mechanisms that lead to airway closure are not completely understood. While the airway of some people narrows and airflow decreases during inspiration due to increasing inspiratory effort, others maintain constant airflow throughout inspiration (negative effort dependence, NED). The investigators hypothesize that upper airway neuromuscular reflexes may protect against narrowing that occurs due to increasing inspiratory effort. Topical oropharyngeal anesthesia has been shown to reduce neuromuscular reflexes. Thus, the investigators also hypothesize that patients with stable inspiratory flow will develop NED once the reflexes have been impaired with topical anesthetic. The investigators plan to:

  1. measure upper airway muscle EMG to assess how it corresponds to the presence or absence of NED. This aim will allow us to test the hypothesis that robust upper airway muscle reflexes can protect against NED.
  2. reduce upper airway muscle activity and reflexes by topical oropharyngeal anesthesia. This will allow us to test the hypothesis that attenuated upper airway muscle activity induced by topical anesthesia can induce NED.
  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:   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 HCl
  • 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): NCT01728974


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

Responsible Party: David Andrew Wellman, Andrew Wellman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01728974     History of Changes
Other Study ID Numbers: 2012P000957A
1R01HL102321-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 14, 2012
First Posted: November 20, 2012
Last Update Posted: September 26, 2013
Last Verified: September 2013

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

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs