Cough Reflex and Obstructive Sleep Apnea Syndrome
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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 |
- To compare cough reflex threshold to citric acid between obese OSAS patients and obese non-OSAS patients
- 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 |
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 |
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| France | |
| Anesthesiology Department, Bichat Hospital | |
| Paris, France, 75018 | |
| 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 Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Citric Acid Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013