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OpenTrials
Completed

NCT Number: NCT00885573

Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome

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.

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Key information

Conditions

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

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Annemasse-Bonneville Hospital, Annemasse, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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 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.

    Time frame: similar to primary outcome measure

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Poitiers University Hospital
  • University Hospital, Geneva
  • University of Liege

Registry information

Official study title

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

Acronym: SENSITEST

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 22, 2009
Registry last updated
May 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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