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

Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome

Sponsors

Lead sponsor: University Hospital, Grenoble

Collaborator: University of Liege
Poitiers University Hospital
University Hospital, Geneva

Source 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.

Overall Status Completed
Start Date December 2008
Completion Date December 2012
Primary Completion Date December 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure 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
Measure 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
Enrollment 52
Condition
Intervention

Intervention type: Device

Intervention name: Measurement of pharyngeal sensitivity (SENSITEST)

Description: Measurement of pharyngeal sensitivity using the SENSITEST the morning following the nocturnal polysomnographic recording to diagnose sleep disordered breathing.

Arm group label: Sleep apnea subjects

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

Gender: Male

Minimum age: 30 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Maurice DEMATTEIS, MD, PhD Principal Investigator University Hospital, Grenoble
Location
facility
Annemasse-Bonneville Hospital | Annemasse, 74107, France
University Hospital of Grenoble | Grenoble, 38043, France
Clinic of Louvière | Lille, 59800, France
Poitiers University Hospital | Poitiers, 86021, France
University Hospital of Geneva | Geneva, 1225, Switzerland
Location Countries

France

Switzerland

Verification Date

May 2014

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Sleep apnea subjects

Arm group type: Other

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.

Acronym SENSITEST
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov