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| Name | Class |
|---|---|
| University Hospital, Grenoble | OTHER |
| ICUREsearch | INDUSTRY |
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Continuous Positive Airway Pressure (CPAP) is the reference treatment of patients suffering from Obstructive Sleep Apnea Syndrome (OSAS).This device functions as a pneumatic stent that stabilizes the upper airway, prevents periodic collapses during sleep.The correction of abnormal respiratory events during sleep allows improvement of symptoms related to OSAS and restores quality of life.The purpose of this study is to validate the efficacy of a new CPAP brand developed by Sleepinnov©.
Obstructive sleep apnea syndrome (OSAS) is characterized by the repetitive occurrence of partial or complete pharyngeal obstructions during sleep.Continuous Positive Airway Pressure (CPAP) is the first line treatment of OSAS.
The aim of the prospective monocentric two steps pilot study SPIRI+ is to validate the efficacy of a new CPAP brand developed by Sleepinnov©.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiri+ | Experimental | new CPAP device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiri+ | Device | CPAP Spiri+ will be weared during one night for each included patient.The validation of the CPAP Spiri+ algorithm will be in the first 10 patients and appreciation of overall clinical efficacy on the 10 last OSAS. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Validation of algorithm detection of respiratory events | Comparison of the total number of events detected by the CPAP Sleepinnov© with data arising from a concurrent polysomnography. | baseline |
| Part 2: Validation of overall clinical efficacy | Percentage of OSAS with an index of residual events below 10 and 5 per hour | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: | Compare the different types of events detected by the Spiri + CPAP algorithm to the concomitant respective indices scored during concurrent | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud Tamisier, PhD | University Hospital, Grenoble | Principal Investigator |
| Jean-Louis Pépin, PhD | University Hospital, Grenoble | Principal Investigator |
| Marie Destors, MD | University Hospital, Grenoble | Principal Investigator |
| Sébastien Baillieul, MD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble | La Tronche | 38700 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27568340 | Background | Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18. | |
| 27188535 | Background | Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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It's a prospective, open, monocentric study.
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |