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

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes; Epilepsies, Partial
• Interventions: Device: CPAP active; Device: CPAP placebo

• Registration Number: NCT03200769
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-21
• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-27
• Primary Completion: 2021-07
• Study Completion: 2021-07
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group IIa	CPAP active	15 \< AHI/h \< 30. Randomization group. Intervention : CPAP active
Group IIb	CPAP placebo	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	CPAP active	AHI/h \> 30. Intervention : CPAP active

Primary Outcome Measures

Name	Time	Method
Number of patients from group IIa and IIb with decreased seizure frequency	At 3 months	Decreased \> 50% after CPAP treatment

Secondary Outcome Measures

Name	Time	Method
Cognitive capacity questionnaire (MOCA)	At 3 months ; At 6 months ; At 12 months	Impact of SAS treatment on cognitive capacity questionnaire
Impact of the localisation and the type of epilepsy based on patient medical history exam (video-electroencephalogram) on the SAS risk	At 12 months	Does the AHI is impacted by the localisation and the type of epilepsy?
Impact of AHI on the number of night seizures	At 12 months	Does the AHI has an impact on the number of night seizure?
Number of seizures based on the seizures diary	At 12 months	Impact of SAS treatment on the pharmacoresistance
Somnolence questionnaire (Epworth)	At 3 months ; At 6 months ; At 12 months	Impact of SAS treatment on somnolence
Number of patients who became drug-susceptible based on the seizures diary	At 3 months ; At 6 months ; At 12 months	Impact of SAS treatment on the pharmacoresistance
Quality of life questionnaire (QOLIE 31)	At 3 months ; At 6 months ; At 12 months	Impact of SAS treatment on the quality of life
Anxiety and depression questionnaire (BECK)	At 3 months ; At 6 months ; At 12 months	Impact of SAS treatment on anxiety and depression
Number of patients from group IIa and IIb with decreased seizure frequency	At 6 months ; At 12 months	Decreased \> 50% after CPAP treatment
Number of patients from group III with decreased seizure frequency	At 3 months ; At 6 months ; At 12 months	Decreased \> 50% after CPAP treatment

Trial Locations

Locations (1)

CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique; 🇫🇷 Lille, France