Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Apnea Syndrome
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 52
- Locations
- 5
- Primary Endpoint
- We aim to compare the novel diagnosis method with nocturnal polysomnography which is the reference method to diagnose sleep disordered breathing.
- Status
- Completed
- Last Updated
- 12 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
We aim to compare the novel diagnosis method with nocturnal polysomnography which is the reference method to diagnose sleep disordered breathing.
Time Frame: Measurement performed the morning following the nocturnal polysomnography
Secondary Outcomes
- 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)