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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Obstructive Sleep Apnea Syndrome Associated With Obesity on Cough Reflex Threshold to Citric Acid
- ClinicalTrials.gov ID
- NCT00317083
- Acronym / sponsor ID
- JG-2006-BCH
- Conditions
- Sleep Apnea Syndrome
- Keywords
- Cough Reflex, Citric acid, Obesity, Sleep apnea syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Bichat HospitalUniversity, hospital or other
- Study start
- Nov 2001
- Study completion
- Feb 2003
- First posted
- 24 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese patient scheduled to undergo bariatric surgery
Key exclusion criteria (12 listed)
- Age less than 18
- Active smoking
- Psychotropic medication
- Angiotensin-converting enzyme inhibitor or angiotensin II receptor antagonist medication
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cough reflex test | Procedure or surgery | – |
Primary outcome
To compare cough reflex threshold to citric acid between obese OSAS patients and obese non-OSAS patients
1 secondary outcome
To correlate OSAS severity assessed by apnea-hypopnea index and cough reflex threshold to citric acid
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2006.
- Background: PubMed 16171271Nguyen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Guglielminotti principal investigator
Anesthesiology Department, Bichat Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cough reflex test in people with Sleep Apnea Syndrome, run by Bichat Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare cough reflex threshold to citric acid between obese OSAS patients and obese non-OSAS patients. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00317083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2006.