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

N/ACompletedNCT03200769

University Hospital, Lille103 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

103

Conditions

Sleep Apnea Syndromes Epilepsies, Partial

Interventions

CPAP activeDEVICE

CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg

CPAP placeboDEVICE

CPAP PR1 Philips Respironics with a constant pression of 4 mm Hg.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique

Lille, France

Outcomes

Primary Outcomes

Number of patients from group IIa and IIb with decreased seizure frequency

Decreased \> 50% after CPAP treatment

Time frame: At 3 months

Secondary Outcomes

Number of patients from group IIa and IIb with decreased seizure frequency

Decreased \> 50% after CPAP treatment

Time frame: At 6 months ; At 12 months

Number of patients from group III with decreased seizure frequency

Decreased \> 50% after CPAP treatment

Time frame: 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?

Time frame: 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?

Time frame: At 12 months

Number of seizures based on the seizures diary

Impact of SAS treatment on the pharmacoresistance

Time frame: At 12 months

Number of patients who became drug-susceptible based on the seizures diary

Impact of SAS treatment on the pharmacoresistance

Time frame: At 3 months ; At 6 months ; At 12 months

Quality of life questionnaire (QOLIE 31)

Data from ClinicalTrials.gov

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