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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-21

Study Completion Date

2021-07-31

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.

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Detailed Description

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Conditions

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Sleep Apnea Syndromes Epilepsies, Partial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group I

AHI/h \< 15

Group Type NO_INTERVENTION

No interventions assigned to this group

Group IIa

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

Group Type EXPERIMENTAL

CPAP active

Intervention Type DEVICE

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

Group IIb

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 Type EXPERIMENTAL

CPAP placebo

Intervention Type DEVICE

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

Group III

AHI/h \> 30. Intervention : CPAP active

Group Type ACTIVE_COMPARATOR

CPAP active

Intervention Type DEVICE

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

Interventions

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CPAP active

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

Intervention Type DEVICE

CPAP placebo

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

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No