Sleep Apnea SyndromeNCT00317083
Cough Reflex and Obstructive Sleep Apnea Syndrome
A study testing Cough reflex test in people with Sleep Apnea Syndrome, run by Bichat Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndrome
- What is being tested?
- Cough reflex test
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2001to Feb 2003
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patient scheduled to undergo bariatric surgery
Who cannot join
- 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
Show all 12Show fewer
- Allergic rhinitis
- Upper airway or bronchopulmonary infection during the previous month
- Chronic cough
- Chronic respiratory disease
- Pharyngolaryngeal disease
- Neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Obstructive Sleep Apnea Syndrome Associated With Obesity on Cough Reflex Threshold to Citric Acid
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).
Read the detailed 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.
- Conditions
- Sleep Apnea Syndrome
- Being tested
- Cough reflex test
- Keywords
- Cough Reflex, Citric acid, Obesity, Sleep apnea syndrome
- Medical subject headings
- Sleep Apnea Syndromes, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough reflex testProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startNov 2001
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Bichat Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jean Guglielminotti, Principal investigator, Anesthesiology Department, Bichat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317083
- Sponsor's protocol ID
- JG-2006-BCH
- Status last verified
- Jan 2004
- First submitted
- 17 Apr 2006
- Last updated
- 24 Apr 2006
- Results posted
- No
Publications
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.
PubMed 16171271