Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome

Sleep Apnea Syndrome Clinical Trial

— SENSITEST  

Official title:

Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885573
• Other study ID #: 0808
• Secondary ID: 2008-A00451-54
• Status: Completed
• Phase: N/A
• First received: April 21, 2009
• Last updated: May 2, 2014
• Start date: December 2008
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes

Intervention

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.

Locations

Country	Name	City	State
France	Annemasse-Bonneville Hospital	Annemasse
France	University Hospital of Grenoble	Grenoble
France	Clinic of Louvière	Lille
France	Poitiers University Hospital	Poitiers
Switzerland	University Hospital of Geneva	Geneva

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Poitiers University Hospital, University Hospital of Liege, University Hospital, Geneva

Countries where clinical trial is conducted

France,  Switzerland, 

References & Publications (10)

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. — View Citation

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

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. — View Citation

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

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No