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Cough Reflex and Obstructive Sleep Apnea Syndrome

NCT ID: NCT00317083

Last Updated: 2006-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2003-02-28

Brief Summary

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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

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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.

Conditions

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Sleep Apnea Syndrome

Keywords

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Cough Reflex Citric acid Obesity Sleep apnea syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Cough reflex test

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bichat Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Jean Guglielminotti

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology Department, Bichat Hospital

Locations

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Anesthesiology Department, Bichat Hospital

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 16171271 (View on PubMed)

Other Identifiers

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JG-2006-BCH

Identifier Type: -

Identifier Source: org_study_id