Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome

NCT00885573 | Completed

• 2 other identifiers: 08082008-A00451-54
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 5

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.

Conditions

Sleep Apnea Syndrome

Keywords

sleep apnea; pharyngeal sensitivity; pharyngeal dilator reflex; diagnosis algorithm; patients with suspected sleep apnea syndrome

Outcome Measures

Primary Outcomes (1)

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

  Measurement performed the morning following the nocturnal polysomnography

Secondary Outcomes (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.

  similar to primary outcome measure

Study Arms (1)

Sleep apnea subjects

OTHER

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)

Interventions

Measurement of pharyngeal sensitivity (SENSITEST) DEVICE

Measurement of pharyngeal sensitivity using the SENSITEST the morning following the nocturnal polysomnographic recording to diagnose sleep disordered breathing.

Sleep apnea subjects

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University of Liege: collaborator
• Poitiers University Hospital: collaborator
• University Hospital, Geneva: collaborator

Study Sites (5)

Annemasse-Bonneville Hospital

Annemasse, 74107, France

Location

University Hospital of Grenoble

Grenoble, 38043, France

Location

Clinic of Louvière

Lille, 59800, France

Location

Poitiers University Hospital

Poitiers, 86021, France

Location

University Hospital of Geneva

Geneva, 1225, Switzerland

Location

Related Publications (10)

• 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.

  PMID: 15860719 BACKGROUND

• 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.

  PMID: 1443879 BACKGROUND

• 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.

  PMID: 11463596 BACKGROUND

• 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.

  PMID: 12226025 BACKGROUND

• 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.

  PMID: 1766303 BACKGROUND

• Friberg D. Heavy snorer's disease: a progressive local neuropathy. Acta Otolaryngol. 1999;119(8):925-33. doi: 10.1080/00016489950180306.

  PMID: 10728936 BACKGROUND

• 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.

  PMID: 15151922 BACKGROUND

• 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.

  PMID: 9872841 BACKGROUND

• Deegan PC, McNicholas WT. Pathophysiology of obstructive sleep apnoea. Eur Respir J. 1995 Jul;8(7):1161-78. doi: 10.1183/09031936.95.08071161.

  PMID: 7589402 BACKGROUND

• 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.

  PMID: 8464434 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Maurice DEMATTEIS, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 22, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 5, 2014

Record last verified: 2014-05

Locations

CH (1); FR (4)