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

U

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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