Status:
COMPLETED
Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
University of Liege
Poitiers University Hospital
Conditions:
Sleep Apnea Syndrome
Eligibility:
MALE
30-65 years
Phase:
NA
Brief Summary
Pharyngeal sensitivity is a determinant parameter of pharyngeal functioning, particularly regarding protective dilator reflexes of upper airway. Preliminary results have suggested that the use of this...
Eligibility Criteria
Inclusion
- consecutively included patients with suspicion of sleep apnea syndrome
- patients who have signed the informed consent form
- patients with body mass index less than or equal 30 kg/m2
Exclusion
- body mass index more than 30 kg/m2
- pharyngeal infection or allergic rhinitis less than 2 weeks before recordings
- craniofacial anomalies and/or limited mouth opening and/or teeth position compromising mouthpiece installation and stability during measurement
- instable dentures
- exaggerated gag reflex preventing pharynx examination
- no visibility of the soft palate
- systemic or topical anti-inflammatory treatments
- treatments that may increase the occurence of nocturnal respiratory events and/or leading to daytime sleepiness and cognitive impairment
- cardiac failure, or symptoms suggesting cardiac failure
- history of stroke
- contraindication for using xylocaine spray
- no affiliation to national insurance
- patient participating in another research study involving drugs that may interfere with sleep recordings and/or measurement of pharyngeal sensation
- patient subjected to exclusion period following participation in another research study
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00885573
Start Date
December 1 2008
End Date
December 1 2012
Last Update
May 5 2014
Active Locations (5)
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1
Annemasse-Bonneville Hospital
Annemasse, France, 74107
2
University Hospital of Grenoble
Grenoble, France, 38043
3
Clinic of Louvière
Lille, France, 59800
4
Poitiers University Hospital
Poitiers, France, 86021