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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
Bichat Hospital
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 17, 2006
Last Updated
April 21, 2006
Sponsor
Bichat Hospital
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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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