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

Primary Purpose

Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Measurement of pharyngeal sensitivity (SENSITEST)
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea Syndrome focused on measuring sleep apnea, pharyngeal sensitivity, pharyngeal dilator reflex, diagnosis algorithm, patients with suspected sleep apnea syndrome

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Annemasse-Bonneville Hospital
  • University Hospital of Grenoble
  • Clinic of Louvière
  • Poitiers University Hospital
  • University Hospital of Geneva

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sleep apnea subjects

Arm Description

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.

Outcomes

Primary Outcome Measures

We aim to compare the novel diagnosis method with nocturnal polysomnography which is the reference method to diagnose sleep disordered breathing.

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.

Full Information

First Posted
April 21, 2009
Last Updated
May 2, 2014
Sponsor
University Hospital, Grenoble
Collaborators
University of Liege, Poitiers University Hospital, University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT00885573
Brief Title
Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome
Acronym
SENSITEST
Official Title
Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
University of Liege, Poitiers University Hospital, University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome
Keywords
sleep apnea, pharyngeal sensitivity, pharyngeal dilator reflex, diagnosis algorithm, patients with suspected sleep apnea syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep apnea subjects
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Measurement of pharyngeal sensitivity (SENSITEST)
Intervention Description
Measurement of pharyngeal sensitivity using the SENSITEST the morning following the nocturnal polysomnographic recording to diagnose sleep disordered breathing.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice DEMATTEIS, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Annemasse-Bonneville Hospital
City
Annemasse
ZIP/Postal Code
74107
Country
France
Facility Name
University Hospital of Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Clinic of Louvière
City
Lille
ZIP/Postal Code
59800
Country
France
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
University Hospital of Geneva
City
Geneva
ZIP/Postal Code
1225
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
15860719
Citation
Dematteis M, Levy P, Pepin JL. A simple procedure for measuring pharyngeal sensitivity: a contribution to the diagnosis of sleep apnoea. Thorax. 2005 May;60(5):418-26. doi: 10.1136/thx.2003.015032.
Results Reference
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PubMed Identifier
1443879
Citation
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. doi: 10.1164/ajrccm/146.5_Pt_1.1246.
Results Reference
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PubMed Identifier
11463596
Citation
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. doi: 10.1164/ajrccm.164.2.2010012.
Results Reference
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PubMed Identifier
12226025
Citation
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. doi: 10.1378/chest.122.3.866.
Results Reference
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PubMed Identifier
1766303
Citation
Woodson BT, Garancis JC, Toohill RJ. Histopathologic changes in snoring and obstructive sleep apnea syndrome. Laryngoscope. 1991 Dec;101(12 Pt 1):1318-22. doi: 10.1002/lary.5541011211.
Results Reference
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PubMed Identifier
10728936
Citation
Friberg D. Heavy snorer's disease: a progressive local neuropathy. Acta Otolaryngol. 1999;119(8):925-33. doi: 10.1080/00016489950180306.
Results Reference
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PubMed Identifier
15151922
Citation
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. doi: 10.1164/rccm.200308-1100OC. Epub 2004 May 19.
Results Reference
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PubMed Identifier
9872841
Citation
Mayer P, Dematteis M, Pepin JL, Wuyam B, Veale D, Vila A, Levy 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. doi: 10.1164/ajrccm.159.1.9709051.
Results Reference
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PubMed Identifier
7589402
Citation
Deegan PC, McNicholas WT. Pathophysiology of obstructive sleep apnoea. Eur Respir J. 1995 Jul;8(7):1161-78. doi: 10.1183/09031936.95.08071161.
Results Reference
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PubMed Identifier
8464434
Citation
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. doi: 10.1056/NEJM199304293281704.
Results Reference
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Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome

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