Cough Reflex and Obstructive Sleep Apnea Syndrome
Primary Purpose
Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cough reflex test
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea Syndrome focused on measuring Cough Reflex, Citric acid, Obesity, Sleep apnea syndrome
Eligibility Criteria
Inclusion Criteria: Obese patient scheduled to undergo bariatric surgery Exclusion Criteria: Age less than 18 Active smoking Psychotropic medication Angiotensin-converting enzyme inhibitor or angiotensin II receptor antagonist medication Pregnancy Anesthesia or endotracheal intubation during the previous month Allergic rhinitis Upper airway or bronchopulmonary infection during the previous month Chronic cough Chronic respiratory disease Pharyngolaryngeal disease Neurological disease
Sites / Locations
- Anesthesiology Department, Bichat Hospital
Outcomes
Primary Outcome Measures
To compare cough reflex threshold to citric acid between obese OSAS patients and obese non-OSAS patients
Secondary Outcome Measures
To correlate OSAS severity assessed by apnea-hypopnea index and cough reflex threshold to citric acid
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00317083
Brief Title
Cough Reflex and Obstructive Sleep Apnea Syndrome
Official Title
Effect of Obstructive Sleep Apnea Syndrome Associated With Obesity on Cough Reflex Threshold to Citric Acid
Study Type
Interventional
2. Study Status
Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bichat Hospital
4. Oversight
5. Study Description
Brief Summary
Up to 70% of obese patients undergoing bariatric surgery have obstructive sleep apnea syndrome (OSAS). OSAS is responsible for laryngeal sensory impairment. As the afferent neural pathway involved in the initiation of cough is located in the laryngeal epithelium, cough reflex sensitivity may be decreased in obese OSAS patients. The researchers therefore conducted this study to determine the effect of OSAS associated with obesity on cough reflex sensitivity, assessed by cough reflex threshold to an inhaled irritant (citric acid).
Detailed Description
Obese patients undergoing scheduled bariatric surgery underwent a cough challenge as part of their routine preoperative evaluation. Patients were classified as presenting OSAS if apnea-hypopnea index obtained from preoperative full-night polysomnography was greater than 5/hour. Cough threshold was measured with citric acid. Increasing concentrations of mouth- nebulized citric acid (2.5, 5, 10, 20, 40, 80, 160, 320 and 640 mg/mL) were delivered during inspiration until a cough was elicited. The citric acid concentration eliciting one cough (C1) was defined as the cough reflex threshold.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome
Keywords
Cough Reflex, Citric acid, Obesity, Sleep apnea syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Cough reflex test
Primary Outcome Measure Information:
Title
To compare cough reflex threshold to citric acid between obese OSAS patients and obese non-OSAS patients
Secondary Outcome Measure Information:
Title
To correlate OSAS severity assessed by apnea-hypopnea index and cough reflex threshold to citric acid
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obese patient scheduled to undergo bariatric surgery
Exclusion Criteria:
Age less than 18
Active smoking
Psychotropic medication
Angiotensin-converting enzyme inhibitor or angiotensin II receptor antagonist medication
Pregnancy
Anesthesia or endotracheal intubation during the previous month
Allergic rhinitis
Upper airway or bronchopulmonary infection during the previous month
Chronic cough
Chronic respiratory disease
Pharyngolaryngeal disease
Neurological disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Guglielminotti
Organizational Affiliation
Anesthesiology Department, Bichat Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesiology Department, Bichat Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
16171271
Citation
Nguyen AT, Jobin V, Payne R, Beauregard J, Naor N, Kimoff RJ. Laryngeal and velopharyngeal sensory impairment in obstructive sleep apnea. Sleep. 2005 May;28(5):585-93. doi: 10.1093/sleep/28.5.585.
Results Reference
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Cough Reflex and Obstructive Sleep Apnea Syndrome
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