Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D
Primary Purpose
Sleep Apnea
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Induced central apneas
Sponsored by
About this trial
This is an interventional other trial for Sleep Apnea focused on measuring Sleep Apnea, Pathophysiology
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 hydrochloride
- For women: Pregnancy
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Viscoelastic properties of the airway
Arm Description
Outcomes
Primary Outcome Measures
Upper airway elasticity
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01733784
First Posted
November 14, 2012
Last Updated
July 9, 2019
Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01733784
Brief Title
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D
Official Title
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Study Start Date
December 8, 2012 (Actual)
Primary Completion Date
February 7, 2017 (Actual)
Study Completion Date
February 7, 2017 (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 (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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Viscoelastic properties of the airway
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Induced central apneas
Primary Outcome Measure Information:
Title
Upper airway elasticity
Description
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).
Time Frame
10 - 40 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 hydrochloride
For women: Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Wellman, MD
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 D
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