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
  Purpose

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).


Condition Intervention
Sleep Apnea Syndrome
Procedure: Cough reflex test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Obstructive Sleep Apnea Syndrome Associated With Obesity on Cough Reflex Threshold to Citric Acid

Resource links provided by NLM:


Further study details as provided by Bichat Hospital:

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

Estimated Enrollment: 40
Study Start Date: November 2001
Estimated Study Completion Date: February 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317083

Locations
France
Anesthesiology Department, Bichat Hospital
Paris, France, 75018
Sponsors and Collaborators
Bichat Hospital
Investigators
Principal Investigator: Jean Guglielminotti Anesthesiology Department, Bichat Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00317083     History of Changes
Other Study ID Numbers: JG-2006-BCH
Study First Received: April 17, 2006
Last Updated: April 21, 2006
Health Authority: France: Ministry of Health

Keywords provided by Bichat Hospital:
Cough Reflex
Citric acid
Obesity
Sleep apnea syndrome

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Syndrome
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014