Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study A
2 other identifiers
interventional
26
1 country
1
Brief Summary
In obstructive sleep apnea, the upper airway recurrently closes during sleep. 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. Airway neuromuscular reflexes may protect against airway narrowing that occurs due to increasing inspiratory effort. To test this hypothesis, the investigators will initially measure airway neuromuscular reflex and inspiratory flow and then attenuate neuromuscular reflex through topical pharyngeal anesthesia to observe the effects on inspiratory flow.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2012
CompletedFirst Posted
Study publicly available on registry
November 20, 2012
CompletedStudy Start
First participant enrolled
December 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2018
CompletedJuly 11, 2019
July 1, 2019
6.1 years
November 14, 2012
July 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Negative effort dependence variation
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
Study Arms (1)
Pharyngeal topical anesthesia
EXPERIMENTALPharyngeal topical anesthesia will be performed using 4% lidocaine spray
Interventions
Pharyngeal topical anesthesia will be performed using 4% lidocaine spray
Eligibility Criteria
You may qualify if:
- Normal subjects or patients with OSA
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Wellman
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Andrew Wellman
Study Record Dates
First Submitted
November 14, 2012
First Posted
November 20, 2012
Study Start
December 8, 2012
Primary Completion
December 26, 2018
Study Completion
December 26, 2018
Last Updated
July 11, 2019
Record last verified: 2019-07