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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03200769

Acronym

SASER

Enrollment

103

Registered

2017-06-27

Start date

2014-07-21

Completion date

2021-07-31

Last updated

2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsies, Partial, Sleep Apnea Syndromes

Keywords

CPAP, Sleep Apnea Syndrome, Pharmacoresistant Epilepsy, Apnea Hypopnea-Index

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.

Interventions

DEVICECPAP active

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

DEVICECPAP placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of seizures based on the seizures diary	At 12 months	Impact of SAS treatment on the pharmacoresistance
Number of patients from group III with decreased seizure frequency	At 3 months ; At 6 months ; At 12 months	Decreased \> 50% after CPAP treatment
Impact of AHI on the number of night seizures	At 12 months	Does the AHI has an impact on the number of night seizure?
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?
Number of patients from group IIa and IIb with decreased seizure frequency	At 6 months ; At 12 months	Decreased \> 50% after CPAP treatment
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
Somnolence questionnaire (Epworth)	At 3 months ; At 6 months ; At 12 months	Impact of SAS treatment on somnolence
Cognitive capacity questionnaire (MOCA)	At 3 months ; At 6 months ; At 12 months	Impact of SAS treatment on cognitive capacity questionnaire
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026