Cough Reflex and Obstructive Sleep Apnea Syndrome

April 21, 2006 updated by: Bichat Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • Anesthesiology Department, Bichat Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare cough reflex threshold to citric acid between obese OSAS patients and obese non-OSAS patients

Secondary Outcome Measures

Outcome Measure
To correlate OSAS severity assessed by apnea-hypopnea index and cough reflex threshold to citric acid

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bichat Hospital

Investigators

  • Principal Investigator: Jean Guglielminotti, Anesthesiology Department, Bichat Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion

February 1, 2003

Study Registration Dates

First Submitted

April 17, 2006

First Submitted That Met QC Criteria

April 21, 2006

First Posted (Estimate)

April 24, 2006

Study Record Updates

Last Update Posted (Estimate)

April 24, 2006

Last Update Submitted That Met QC Criteria

April 21, 2006

Last Verified

January 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JG-2006-BCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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