NCT00317083

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2006

Completed
Last Updated

April 24, 2006

Status Verified

January 1, 2004

First QC Date

April 17, 2006

Last Update Submit

April 21, 2006

Conditions

Sleep Apnea Syndrome

Keywords

Cough ReflexCitric acidObesitySleep apnea syndrome

Outcome Measures

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

Interventions

Cough reflex testPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese patient scheduled to undergo bariatric surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology Department, Bichat Hospital

Paris, 75018, France

Location

Related 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. doi: 10.1093/sleep/28.5.585.

    PMID: 16171271BACKGROUND

MeSH Terms

Conditions

Sleep Apnea SyndromesObesity

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean Guglielminotti

    Anesthesiology Department, Bichat Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2006

First Posted

April 24, 2006

Study Start

November 1, 2001

Study Completion

February 1, 2003

Last Updated

April 24, 2006

Record last verified: 2004-01

Locations

FR(1)