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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01156-39 | Other Identifier | ID-RCB number, ANSM |
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Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep apnea syndrome treatment by CPAP on the epilepsy seizures frequency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | No Intervention | AHI/h < 15 | |
| Group IIa | Experimental | 15 < AHI/h < 30. Randomization group. Intervention : CPAP active |
|
| Group IIb | Experimental | 15 < AHI/h < 30. Randomization group. Intervention : CPAP placebo during the first 3 months. After this period, the patient will have the possibility to continue with an active CPAP. |
|
| Group III | Active Comparator | AHI/h > 30. Intervention : CPAP active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP active | Device | CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients from group IIa and IIb with decreased seizure frequency | Decreased > 50% after CPAP treatment | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients from group IIa and IIb with decreased seizure frequency | Decreased > 50% after CPAP treatment | At 6 months ; At 12 months |
| Number of patients from group III with decreased seizure frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe DERAMBURE, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| CPAP placebo | Device | CPAP PR1 Philips Respironics with a constant pression of 4 mm Hg. |
|
Decreased > 50% after CPAP treatment
| At 3 months ; At 6 months ; At 12 months |
| Impact of AHI on the number of night seizures | Does the AHI has an impact on the number of night seizure? | At 12 months |
| Impact of the localisation and the type of epilepsy based on patient medical history exam (video-electroencephalogram) on the SAS risk | Does the AHI is impacted by the localisation and the type of epilepsy? | At 12 months |
| Number of seizures based on the seizures diary | Impact of SAS treatment on the pharmacoresistance | At 12 months |
| Number of patients who became drug-susceptible based on the seizures diary | Impact of SAS treatment on the pharmacoresistance | At 3 months ; At 6 months ; At 12 months |
| Quality of life questionnaire (QOLIE 31) | Impact of SAS treatment on the quality of life | At 3 months ; At 6 months ; At 12 months |
| Anxiety and depression questionnaire (BECK) | Impact of SAS treatment on anxiety and depression | At 3 months ; At 6 months ; At 12 months |
| Somnolence questionnaire (Epworth) | Impact of SAS treatment on somnolence | At 3 months ; At 6 months ; At 12 months |
| Cognitive capacity questionnaire (MOCA) | Impact of SAS treatment on cognitive capacity questionnaire | At 3 months ; At 6 months ; At 12 months |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |