Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome (SENSITEST)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Sleep Apnea Syndrome

Treatments: Device: Measurement of pharyngeal sensitivity (SENSITEST)

Study type: Interventional

Funder types: Other

Identifiers

NCT00885573

2008-A00451-54 (Registry Identifier)

0808

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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52 participants in 1 patient group

Sleep apnea subjects

Other group

Description:

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.

Treatment:

Device: Measurement of pharyngeal sensitivity (SENSITEST)