Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome - Full Text View

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:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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:

Dematteis M, Lévy P, Pépin JL. A simple procedure for measuring pharyngeal sensitivity: a contribution to the diagnosis of sleep apnoea. Thorax. 2005 May;60(5):418-26.

Larsson H, Carlsson-Nordlander B, Lindblad LE, Norbeck O, Svanborg E. Temperature thresholds in the oropharynx of patients with obstructive sleep apnea syndrome. Am Rev Respir Dis. 1992 Nov;146(5 Pt 1):1246-9.

Kimoff RJ, Sforza E, Champagne V, Ofiara L, Gendron D. Upper airway sensation in snoring and obstructive sleep apnea. Am J Respir Crit Care Med. 2001 Jul 15;164(2):250-5.

Guilleminault C, Li K, Chen NH, Poyares D. Two-point palatal discrimination in patients with upper airway resistance syndrome, obstructive sleep apnea syndrome, and normal control subjects. Chest. 2002 Sep;122(3):866-70.

Woodson BT, Garancis JC, Toohill RJ. Histopathologic changes in snoring and obstructive sleep apnea syndrome. Laryngoscope. 1991 Dec;101(12 Pt 1):1318-22.

Friberg D. Heavy snorer's disease: a progressive local neuropathy. Acta Otolaryngol. 1999;119(8):925-33.

Boyd JH, Petrof BJ, Hamid Q, Fraser R, Kimoff RJ. Upper airway muscle inflammation and denervation changes in obstructive sleep apnea. Am J Respir Crit Care Med. 2004 Sep 1;170(5):541-6. Epub 2004 May 19.

Mayer P, Dematteis M, Pépin JL, Wuyam B, Veale D, Vila A, Lévy P. Peripheral neuropathy in sleep apnea. A tissue marker of the severity of nocturnal desaturation. Am J Respir Crit Care Med. 1999 Jan;159(1):213-9.

Deegan PC, McNicholas WT. Pathophysiology of obstructive sleep apnoea. Eur Respir J. 1995 Jul;8(7):1161-78. Review.

Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5.

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 May 16, 2013

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