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
  Purpose

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 Intervention
Sleep Apnea Syndrome
Device: Measurement of pharyngeal sensitivity (SENSITEST)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: December 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885573

Contacts
Contact: Maurice DEMATTEIS, MD, PhD 476637171 ext 33 maurice.dematteis@ujf-grenoble.fr

Locations
France
Annemasse-Bonneville Hospital Recruiting
Annemasse, France, 74107
Contact: José HABA-RUBIO, MD    450874611 ext 33    jhabarubio@chi-annemasse-bonneville.fr   
Sub-Investigator: José HABA-RUBIO, MD         
University Hospital of Grenoble Recruiting
Grenoble, France, 38043
Contact: Maurice DEMATTEIS, MD, PhD    476637171 ext 33    maurice.dematteis@ujf-grenoble.fr   
Principal Investigator: Maurice DEMATTEIS, M, PhD         
Sub-Investigator: Patrick LEVY, MD, PhD         
Sub-Investigator: Jean-Louis PEPIN, MD, PhD         
Sub-Investigator: Sandrine LAUNOIS, MD, PhD         
Clinic of Louvière Recruiting
Lille, France, 59800
Contact: Thibaut GENTINA, MD    320160530 ext 33    t.gentina@wanadoo.fr   
Sub-Investigator: Thibaut GENTINA, MD         
Poitiers University Hospital Recruiting
Poitiers, France, 86021
Contact: Joel PAQUEREAU, MD, PhD    549444387 ext 33    joel.paquereau@chu-poitiers.fr   
Sub-Investigator: Joel PAQUEREAU, MD, PhD         
Switzerland
University Hospital of Geneva Not yet recruiting
Geneva, Switzerland, 1225
Contact: Stephen PERRIG, MD    223055329 ext 41    Stephen.Perrig@hcuge.ch   
Sub-Investigator: Stephen PERRIG, MD         
Sponsors and Collaborators
University Hospital, Grenoble
University Hospital of Liege
Poitiers University Hospital
University Hospital, Geneva
Investigators
Principal Investigator: Maurice DEMATTEIS, MD, PhD University Hospital, Grenoble
  More Information

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00885573     History of Changes
Other Study ID Numbers: 0808, 2008-A00451-54
Study First Received: April 21, 2009
Last Updated: February 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014