Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C
Primary Purpose
Sleep Apnea
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Administration of gas mixtures
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
Gas mixture administration
Arm Description
Subjects will breathe different gas mixtures with different densities and viscosity for brief periods in order to promote changes in peak inspiratory flow
Outcomes
Primary Outcome Measures
Difference in peak inspiratory flow
Observed peak inspiratory flow while breathing different gas mixtures will be compared to model predicted flows.
Subjects will breathe different gas mixtures for 2 consecutive breaths only. Therefore the time frame is equal to one breath before gas mixture administration and two breaths after (usually 10-15 seconds).
Secondary Outcome Measures
Full Information
NCT ID
NCT01738022
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
NCT01738022
Brief Title
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C
Official Title
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C
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Withdrawn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. Models to study mechanisms of airway collapse have been proposed. However, these models have not been tested in the human upper airway. Gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models. In this study, subjects will breathe gas mixtures of different densities and viscosities for brief periods of time in order to test those models.
Detailed Description
Models to study mechanisms of airway collapse have been proposed. However, these models have not been tested in the human upper airway. Gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models.
In this study, subjects will breathe gas mixtures of different densities (helium and sulfur-hexafluoride) or viscosity (neon) for brief periods of time during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP). The investigators will test some models of upper airway collapse by observing if flow while breathing different gas mixtures scales according to the differences in density and viscosity.
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
Gas mixture administration
Arm Type
Experimental
Arm Description
Subjects will breathe different gas mixtures with different densities and viscosity for brief periods in order to promote changes in peak inspiratory flow
Intervention Type
Other
Intervention Name(s)
Administration of gas mixtures
Other Intervention Name(s)
Heliox, Sulfur-hexafluoride, Neon
Primary Outcome Measure Information:
Title
Difference in peak inspiratory flow
Description
Observed peak inspiratory flow while breathing different gas mixtures will be compared to model predicted flows.
Subjects will breathe different gas mixtures for 2 consecutive breaths only. Therefore the time frame is equal to one breath before gas mixture administration and two breaths after (usually 10-15 seconds).
Time Frame
10 - 15 seconds
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 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 C
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