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Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study A

Primary Purpose

Obstructive Sleep Apnea, Pathophysiology

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharyngeal topical anesthesia
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Pathophysiology

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pharyngeal topical anesthesia

Arm Description

Pharyngeal topical anesthesia will be performed using 4% lidocaine spray

Outcomes

Primary Outcome Measures

Negative effort dependence variation
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

Secondary Outcome Measures

Full Information

First Posted
November 14, 2012
Last Updated
July 9, 2019
Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01728974
Brief Title
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study A
Official Title
Mechanisms of Pharyngeal Collapse in Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 8, 2012 (Actual)
Primary Completion Date
December 26, 2018 (Actual)
Study Completion Date
December 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Pathophysiology
Keywords
Obstructive Sleep Apnea, Pathophysiology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharyngeal topical anesthesia
Arm Type
Experimental
Arm Description
Pharyngeal topical anesthesia will be performed using 4% lidocaine spray
Intervention Type
Other
Intervention Name(s)
Pharyngeal topical anesthesia
Intervention Description
Pharyngeal topical anesthesia will be performed using 4% lidocaine spray
Primary Outcome Measure Information:
Title
Negative effort dependence variation
Description
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
Time Frame
After pharyngeal topical anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Wellman
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study A

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