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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00885573
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : May 5, 2014
University of Liege
Poitiers University Hospital
University Hospital, Geneva
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndrome Device: Measurement of pharyngeal sensitivity (SENSITEST) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing
Study Start Date : December 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Sleep Apnea

Arm Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00885573

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Annemasse-Bonneville Hospital
Annemasse, France, 74107
University Hospital of Grenoble
Grenoble, France, 38043
Clinic of Louvière
Lille, France, 59800
Poitiers University Hospital
Poitiers, France, 86021
University Hospital of Geneva
Geneva, Switzerland, 1225
Sponsors and Collaborators
University Hospital, Grenoble
University of Liege
Poitiers University Hospital
University Hospital, Geneva
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Principal Investigator: Maurice DEMATTEIS, MD, PhD University Hospital, Grenoble

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Responsible Party: University Hospital, Grenoble Identifier: NCT00885573    
Other Study ID Numbers: 0808
2008-A00451-54 ( Registry Identifier: ID RCB )
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: May 5, 2014
Last Verified: May 2014
Keywords provided by University Hospital, Grenoble:
sleep apnea
pharyngeal sensitivity
pharyngeal dilator reflex
diagnosis algorithm
patients with suspected sleep apnea syndrome
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Immune System Diseases