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

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Grenoble
Sponsor:
Collaborators:
University Hospital of Liege
Poitiers University Hospital
University Hospital, Geneva
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00885573
First received: April 21, 2009
Last updated: February 18, 2013
Last verified: February 2013

April 21, 2009
February 18, 2013
December 2008
December 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00885573 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
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Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome
Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing

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.

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Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Sleep Apnea Syndrome
Device: Measurement of pharyngeal sensitivity (SENSITEST)
Measurement of pharyngeal sensitivity using the SENSITEST the morning following the nocturnal polysomnographic recording to diagnose sleep disordered breathing.
Sleep apnea subjects
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.
Intervention: Device: Measurement of pharyngeal sensitivity (SENSITEST)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Male
30 Years to 65 Years
No
Contact: Maurice DEMATTEIS, MD, PhD 476637171 ext 33 maurice.dematteis@ujf-grenoble.fr
France,   Switzerland
 
NCT00885573
0808, 2008-A00451-54
No
University Hospital, Grenoble
University Hospital, Grenoble
  • University Hospital of Liege
  • Poitiers University Hospital
  • University Hospital, Geneva
Principal Investigator: Maurice DEMATTEIS, MD, PhD University Hospital, Grenoble
University Hospital, Grenoble
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP