Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome

Not Applicable

Completed

• Conditions: Sleep Apnea Syndrome
• Interventions: Device: Measurement of pharyngeal sensitivity (SENSITEST)

• Registration Number: NCT00885573
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-02
• Last Update Posted: 2014-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sleep apnea subjects	Measurement of pharyngeal sensitivity (SENSITEST)	Patients with suspected sleep apnea syndrome will have nocturnal polysomnography. According to the number of respiratory events per hour of sleep, patients will be classified as "sleep apnea" or "controls". All the patients will be blindly assessed for pharyngeal sensitivity the morning following the nocturnal recording.

Primary Outcome Measures

Name	Time	Method
We aim to compare the novel diagnosis method with nocturnal polysomnography which is the reference method to diagnose sleep disordered breathing.	Measurement performed the morning following the nocturnal polysomnography

Secondary Outcome Measures

Name	Time	Method
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.	similar to primary outcome measure

Trial Locations

Locations (5)

Annemasse-Bonneville Hospital; 🇫🇷 Annemasse, France

University Hospital of Geneva; 🇨🇭 Geneva, Switzerland

University Hospital of Grenoble; 🇫🇷 Grenoble, France

Clinic of Louvière; 🇫🇷 Lille, France

Poitiers University Hospital; 🇫🇷 Poitiers, France