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Completed

NCT Number: NCT00317083

Cough Reflex and Obstructive Sleep Apnea Syndrome

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).

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Key information

Conditions

Sleep Apnea Syndrome Apnea Body Weight Dyssomnias Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesiology Department, Bichat Hospital

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cough reflex test

Procedure

Primary outcomes

  1. To compare cough reflex threshold to citric acid between obese OSAS patients and obese non-OSAS patients

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Bichat Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2003
First posted
Apr 24, 2006
Registry last updated
Apr 24, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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