Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00885573
• Date of registration: 21/04/2009
• Prospective Registration: No
• Primary sponsor: University Hospital, Grenoble
• Public title: Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome SENSITEST
• Scientific title: Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing
• Date of first enrolment: December 2008
• Target sample size: 52
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00885573
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

France, Switzerland

Contacts

• Name: Maurice DEMATTEIS, MD, PhD
• Affiliation: University Hospital, Grenoble

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Sleep Apnea Syndrome

Intervention(s)

Device: Measurement of pharyngeal sensitivity (SENSITEST)

Primary Outcome(s)

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 Outcome(s)

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. [Time Frame: similar to primary outcome measure]

Secondary ID(s)

2008-A00451-54

0808

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital of Liege

Poitiers University Hospital

University Hospital, Geneva