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ESTAMPS is a randomized clinical trial with a crossover design:
Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design) on upper airway volume
secondary objectives: To evaluate the maximal mandibular propulsion according to the type of MRD To evaluate benefits on quality of life, sleepiness and OSA symptoms To evaluate impact of MRD design on therapy efficacy and tolerance To evaluate impact of MRD design on mandibular positioning
Hypothesis ORCADES results suggest that Narval O.R.M CC could be more efficient than Narval MRD trad to reduce AHI whatever the initial OSA severity 79% of CC MRD patients have at least an AHI reduction of 50% (vs. 61% with a trad Narval MRD, p=0.0031) 66% of CC MRD patients get a complete answer with an AHI reduction <10 (vs. 49% with a trad Narval MRD, p=0.0017) The investigators think that differences seen in the ORCADES study between the 2 MRD is due to a different impact on upper airway volume
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narval O.R.M CCâ„¢ | Active Comparator | First mandibular retention device : Narval O.R.M CCâ„¢ |
|
| Narval O.R.Mâ„¢ trad | Active Comparator | Second mandibular retention device : Narval O.R.M TRADâ„¢ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular Retention Device | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| upper airway volume | investigators will measure upper airway volume (cm3) changes produced by 2 different Mandibular Retention Devices in Obstructive sleep apnea syndrome (OSA) patients | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| maximal mandibular propulsion | investigators will measure the maximal mandibular propulsion (in millimeter) at the end of MRD titration | 1 month |
| quality of sleep | investigators will use specific quality of sleep questionnaire: Pittsburgh sleep quality index (PSQI), |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Baptiste Kerbrat, MD | CHU Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Rouen | Rouen | France |
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| 1 month |
| sleepiness | investigators will use a specific sleepiness questionnaire: Epworth sleepiness scale (ESS) | 1 month |
| MRD therapy efficacy | investigators will measure the residual Apnea and Hypopnea Index (AHI) via polygraphy | 1 month |
| mandibular positioning | investigators will measure the mandibular positioning under MRD therapy (in millimeter) | 1 month |
| Occlusal vertical dimension | investigators will measure the occlusal vertical dimension changes (in millimeter) between the 2 type of MRD | 1 month |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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