Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome (SENSITEST)
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| First Received Date ICMJE | April 21, 2009 | ||||
| Last Updated Date | February 18, 2013 | ||||
| Start Date ICMJE | December 2008 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00885573 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome | ||||
| Official Title ICMJE | Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | Sleep Apnea Syndrome | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | 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.
Intervention: Device: Measurement of pharyngeal sensitivity (SENSITEST) |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 30 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France, Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00885573 | ||||
| Other Study ID Numbers ICMJE | 0808, 2008-A00451-54 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University Hospital, Grenoble | ||||
| Study Sponsor ICMJE | University Hospital, Grenoble | ||||
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| Information Provided By | University Hospital, Grenoble | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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