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

University Hospital, Lille

Status: Completed

Conditions: Sleep Apnea Syndromes; Epilepsies, Partial

Treatments: Device: CPAP active; Device: CPAP placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03200769

2013-A01156-39 (Other Identifier)

2012_66

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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103 participants in 4 patient groups

Group I

No Intervention group

Description:

AHI/h < 15

Group IIa

Experimental group

Description:

15 < AHI/h < 30. Randomization group. Intervention : CPAP active

Treatment:

Device: CPAP active

Group IIb

Experimental group

Description:

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.

Treatment:

Device: CPAP placebo

Group III

Active Comparator group

Description:

AHI/h > 30. Intervention : CPAP active

Treatment:

Device: CPAP active