Clinical trial NCT00885573: Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome
Official title: Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndrome
Keywords: sleep apnea
pharyngeal sensitivity
pharyngeal dilator reflex
diagnosis algorithm
patients with suspected sleep apnea syndrome
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University of Liege
name: Poitiers University Hospital
name: University Hospital, Geneva
First posted: 2009-04-22
Enrollment: 52
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 parameter in diagnosis algorithm such as linear discriminant analysis and random forest could predict the presence of sleep apnea syndrome in almost 98% of patients. Our study aims at validating a new diagnosis method of sleep disordered breathing which will be compared with nocturnal polysomnography, the reference method to diagnose sleep disordered breathing. Pharyngeal sensitivity will be measured using the SENSITEST device which allows an automatic measurement of the pharyngeal sensation. The use of this parameter in diagnosis algorithm will be compared with polysomnographic results.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: We aim to compare the novel diagnosis method with nocturnal polysomnography which is the reference method to diagnose sleep disordered breathing.
timeFrame: Measurement performed the morning following the nocturnal polysomnography
Secondary outcomes:
measure: We will determine the severity of sleep apnea for which pharyngeal sensitivity is predictive of sleep apnea syndrome. To simplify the procedure, we will precise the role of pharyngeal anesthesia in the diagnostic predictive value of the algorithm.
timeFrame: similar to primary outcome measure
Other outcomes:
Locations:
city: Annemasse
country: France
facility: Annemasse-Bonneville Hospital
city: Grenoble
country: France
facility: University Hospital of Grenoble
city: Lille
country: France
facility: Clinic of Louvière
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
Study officials:
affiliation: University Hospital, Grenoble
name: Maurice DEMATTEIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dematteis M, Levy P, Pepin JL. A simple procedure for measuring pharyngeal sensitivity: a contribution to the diagnosis of sleep apnoea. Thorax. 2005 May;60(5):418-26. doi: 10.1136/thx.2003.015032.
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citation: Mayer P, Dematteis M, Pepin JL, Wuyam B, Veale D, Vila A, Levy P. Peripheral neuropathy in sleep apnea. A tissue marker of the severity of nocturnal desaturation. Am J Respir Crit Care Med. 1999 Jan;159(1):213-9. doi: 10.1164/ajrccm.159.1.9709051.
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citation: Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.