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

May 2, 2014 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annemasse, France, 74107
        • Annemasse-Bonneville Hospital
      • Grenoble, France, 38043
        • University hospital of Grenoble
      • Lille, France, 59800
        • Clinic of Louvière
      • Poitiers, France, 86021
        • Poitiers university hospital
  • Switzerland
      • Geneva, Switzerland, 1225
        • University Hospital of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

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.
Time Frame: Measurement performed the morning following the nocturnal polysomnography
Measurement performed the morning following the nocturnal polysomnography

Secondary Outcome Measures

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.
Time Frame: similar to primary outcome measure
similar to primary outcome measure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

University Hospital, Geneva
University of Liege
Poitiers University Hospital

Investigators

  • Principal Investigator: Maurice DEMATTEIS, MD, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (ESTIMATE)

April 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 5, 2014

Last Update Submitted That Met QC Criteria

May 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0808
  • 2008-A00451-54 (REGISTRY: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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