Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study A
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea Pathophysiology |
Other: Pharyngeal topical anesthesia |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Mechanisms of Pharyngeal Collapse in Sleep Apnea |
- Negative effort dependence variation [ Time Frame: After pharyngeal topical anesthesia ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pharyngeal topical anesthesia
Pharyngeal topical anesthesia will be performed using 4% lidocaine spray
|
Other: Pharyngeal topical anesthesia
Pharyngeal topical anesthesia will be performed using 4% lidocaine spray
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Pedro R Genta, MD | (617) 732-6541 | pgenta@partners.org |
| Contact: Lauren B Hess, BS | (617) 732-8976 | lhess1@partners.org |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: David A Wellman, MD | |
| Sub-Investigator: Pedro R Genta, MD | |
| Principal Investigator: | David A Wellman | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | David Andrew Wellman, Andrew Wellman, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01728974 History of Changes |
| Other Study ID Numbers: | 2012P000957A, 1R01HL102321-01A1 |
| Study First Received: | November 14, 2012 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
Obstructive Sleep Apnea Pathophysiology |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Sleep Disorders, Intrinsic Sleep Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Dyssomnias Nervous System Diseases Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013