Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome

Study Overview
=================
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.

Official Title
-----------------
Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing

Conditions
-----------------
Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Device: Measurement of pharyngeal sensitivity (SENSITEST)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sleep apnea subjects<br>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. | Device: Measurement of pharyngeal sensitivity (SENSITEST)<br>* Measurement of pharyngeal sensitivity using the SENSITEST the morning following the nocturnal polysomnographic recording to diagnose sleep disordered breathing.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep apnea, pharyngeal sensitivity, pharyngeal dilator reflex, diagnosis algorithm, patients with suspected sleep apnea syndrome