Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B
Primary Purpose
Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Induction of flow limitation
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 hydroclhoride
- For women: Pregnancy
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Induction of flow limitation
Arm Description
Flow limitation will be induced by sustained reductions in continuous positive airway pressure during sleep
Outcomes
Primary Outcome Measures
Difference in peak inspiratory flow
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01738009
First Posted
November 14, 2012
Last Updated
February 23, 2022
Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01738009
Brief Title
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B
Official Title
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 8, 2012 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (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 cause of PEN is unknown. The investigators will test if lung volumes and low respiratory drive play a role in PEN.
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).
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
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Induction of flow limitation
Arm Type
Experimental
Arm Description
Flow limitation will be induced by sustained reductions in continuous positive airway pressure during sleep
Intervention Type
Other
Intervention Name(s)
Induction of flow limitation
Primary Outcome Measure Information:
Title
Difference in peak inspiratory flow
Description
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.
Time Frame
3 minutes
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 hydroclhoride
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 B
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