- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01728974
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study A
Mechanisms of Pharyngeal Collapse in Sleep Apnea
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
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 HCl
- 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: Pharyngeal topical anesthesia
Pharyngeal topical anesthesia will be performed using 4% lidocaine spray
|
Pharyngeal topical anesthesia will be performed using 4% lidocaine spray
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Negative effort dependence variation
Time Frame: After pharyngeal topical anesthesia
|
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
|
After pharyngeal topical anesthesia
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David A Wellman, 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
- 2012P000957A
- 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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