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Completed

NCT Number: NCT03200769

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

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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Key information

Conditions

Sleep Apnea Syndromes Apnea Brain Diseases Central Nervous System Diseases Dyssomnias Epilepsies, Partial Epilepsy Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP active

Device

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

CPAP placebo

Device

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

Primary outcomes

  1. Number of patients from group IIa and IIb with decreased seizure frequency

    Time frame: At 3 months

    Decreased > 50% after CPAP treatment

Secondary outcomes

  1. Number of patients from group IIa and IIb with decreased seizure frequency

    Time frame: At 6 months ; At 12 months

    Decreased > 50% after CPAP treatment

  2. Number of patients from group III with decreased seizure frequency

    Time frame: At 3 months ; At 6 months ; At 12 months

    Decreased > 50% after CPAP treatment

  3. Impact of AHI on the number of night seizures

    Time frame: At 12 months

    Does the AHI has an impact on the number of night seizure?

  4. Impact of the localisation and the type of epilepsy based on patient medical history exam (video-electroencephalogram) on the SAS risk

    Time frame: At 12 months

    Does the AHI is impacted by the localisation and the type of epilepsy?

  5. Number of seizures based on the seizures diary

    Time frame: At 12 months

    Impact of SAS treatment on the pharmacoresistance

  6. Number of patients who became drug-susceptible based on the seizures diary

    Time frame: At 3 months ; At 6 months ; At 12 months

    Impact of SAS treatment on the pharmacoresistance

  7. Quality of life questionnaire (QOLIE 31)

    Time frame: At 3 months ; At 6 months ; At 12 months

    Impact of SAS treatment on the quality of life

  8. Anxiety and depression questionnaire (BECK)

    Time frame: At 3 months ; At 6 months ; At 12 months

    Impact of SAS treatment on anxiety and depression

  9. Somnolence questionnaire (Epworth)

    Time frame: At 3 months ; At 6 months ; At 12 months

    Impact of SAS treatment on somnolence

  10. Cognitive capacity questionnaire (MOCA)

    Time frame: At 3 months ; At 6 months ; At 12 months

    Impact of SAS treatment on cognitive capacity questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: SASER

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jun 27, 2017
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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