Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study A

This study is currently recruiting participants.
Verified September 2013 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01728974
First received: November 14, 2012
Last updated: September 25, 2013
Last verified: September 2013
  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: Open Label
Official Title: Mechanisms of Pharyngeal Collapse in Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Negative effort dependence variation [ Time Frame: After pharyngeal topical anesthesia ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: David A Wellman Brigham and Women's Hospital
  More Information

No publications provided

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
Study First Received: November 14, 2012
Last Updated: September 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Obstructive Sleep Apnea
Pathophysiology

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

ClinicalTrials.gov processed this record on April 17, 2014