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Cough Reflex and Obstructive Sleep Apnea Syndrome

This study has been completed.
Sponsor:
Information provided by:
Bichat Hospital
ClinicalTrials.gov Identifier:
NCT00317083
First received: April 17, 2006
Last updated: April 21, 2006
Last verified: January 2004

April 17, 2006
April 21, 2006
November 2001
Not Provided
To compare cough reflex threshold to citric acid between obese OSAS patients and obese non-OSAS patients
Same as current
Complete list of historical versions of study NCT00317083 on ClinicalTrials.gov Archive Site
To correlate OSAS severity assessed by apnea-hypopnea index and cough reflex threshold to citric acid
Same as current
Not Provided
Not Provided
 
Cough Reflex and Obstructive Sleep Apnea Syndrome
Effect of Obstructive Sleep Apnea Syndrome Associated With Obesity on Cough Reflex Threshold to Citric Acid

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).

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Sleep Apnea Syndrome
Procedure: Cough reflex test
Not Provided
Nguyen AT, Jobin V, Payne R, Beauregard J, Naor N, Kimoff RJ. Laryngeal and velopharyngeal sensory impairment in obstructive sleep apnea. Sleep. 2005 May 1;28(5):585-93.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2003
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00317083
JG-2006-BCH
Not Provided
Not Provided
Bichat Hospital
Not Provided
Principal Investigator: Jean Guglielminotti Anesthesiology Department, Bichat Hospital
Bichat Hospital
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP