Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy

Conditions
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Sleep Apnea Syndromes, Epilepsies, Partial

Intervention / Treatment
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* Device: CPAP active
* Device: CPAP placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age ≥ 18. Patient suffering of pharmacoresistant epilepsy. Frequency of epilepsy crisis : minimum 4 per month. Antiepileptic drug on a stable dose for at least 2 months. SA-SDQ score ≥ 25. Written informed consent obtained. Patient affiliated with a social security regimen. Exclusion Criteria: Pregnant females (female subjects who are lactating are not excluded). Anterior CPAP treatment. Central apnea >20% during the initial polysomnography. Mental retardation or severe cognitive impairment. Presence of pseudo-crisis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group I<br>AHI/h < 15 | |
| Experimental: Group IIa<br>15 < AHI/h < 30. Randomization group. Intervention : CPAP active | Device: CPAP active<br>* CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg<br>|
| Experimental: Group IIb<br>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. | Device: CPAP placebo<br>* CPAP PR1 Philips Respironics with a constant pression of 4 mm Hg.<br>|
| Active Comparator: Group III<br>AHI/h > 30. Intervention : CPAP active | Device: CPAP active<br>* CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients from group IIa and IIb with decreased seizure frequency | Decreased > 50% after CPAP treatment | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, Sleep Apnea Syndrome, Pharmacoresistant Epilepsy, Apnea Hypopnea-Index