- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01738022
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gas mixture administration
Subjects will breathe different gas mixtures with different densities and viscosity for brief periods in order to promote changes in peak inspiratory flow
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in peak inspiratory flow
Time Frame: 10 - 15 seconds
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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). |
10 - 15 seconds
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David A Wellman, MD, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012P000957C
- 1R01HL102321-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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