Cough Reflex and Obstructive Sleep Apnea Syndrome

Sleep Apnea Syndrome Clinical Trial

Official title:

Effect of Obstructive Sleep Apnea Syndrome Associated With Obesity on Cough Reflex Threshold to Citric Acid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317083
• Other study ID #: JG-2006-BCH
• Status: Completed
• Phase: N/A
• First received: April 17, 2006
• Last updated: April 21, 2006
• Start date: November 2001
• Est. completion date: February 2003

Study information

• Verified date: January 2004
• Source: Bichat Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Procedure:
• Cough reflex test

Locations

Country	Name	City	State
France	Anesthesiology Department, Bichat Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Bichat Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare cough reflex threshold to citric acid between obese OSAS patients and obese non-OSAS patients
Secondary	To correlate OSAS severity assessed by apnea-hypopnea index and cough reflex threshold to citric acid