Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy (SASER)
Primary Purpose
Sleep Apnea Syndromes, Epilepsies, Partial
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CPAP active
CPAP placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring CPAP, Sleep Apnea Syndrome, Pharmacoresistant Epilepsy, Apnea Hypopnea-Index
Eligibility Criteria
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.
Sites / Locations
- CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Active Comparator
Arm Label
Group I
Group IIa
Group IIb
Group III
Arm Description
AHI/h < 15
15 < AHI/h < 30. Randomization group. Intervention : CPAP active
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.
AHI/h > 30. Intervention : CPAP active
Outcomes
Primary Outcome Measures
Number of patients from group IIa and IIb with decreased seizure frequency
Decreased > 50% after CPAP treatment
Secondary Outcome Measures
Number of patients from group IIa and IIb with decreased seizure frequency
Decreased > 50% after CPAP treatment
Number of patients from group III with decreased seizure frequency
Decreased > 50% after CPAP treatment
Impact of AHI on the number of night seizures
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
Does the AHI is impacted by the localisation and the type of epilepsy?
Number of seizures based on the seizures diary
Impact of SAS treatment on the pharmacoresistance
Number of patients who became drug-susceptible based on the seizures diary
Impact of SAS treatment on the pharmacoresistance
Quality of life questionnaire (QOLIE 31)
Impact of SAS treatment on the quality of life
Anxiety and depression questionnaire (BECK)
Impact of SAS treatment on anxiety and depression
Somnolence questionnaire (Epworth)
Impact of SAS treatment on somnolence
Cognitive capacity questionnaire (MOCA)
Impact of SAS treatment on cognitive capacity questionnaire
Full Information
NCT ID
NCT03200769
First Posted
June 12, 2017
Last Updated
September 29, 2022
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT03200769
Brief Title
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy
Acronym
SASER
Official Title
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 21, 2014 (Actual)
Primary Completion Date
July 2021 (Actual)
Study Completion Date
July 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Epilepsies, Partial
Keywords
CPAP, Sleep Apnea Syndrome, Pharmacoresistant Epilepsy, Apnea Hypopnea-Index
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
No Intervention
Arm Description
AHI/h < 15
Arm Title
Group IIa
Arm Type
Experimental
Arm Description
15 < AHI/h < 30. Randomization group. Intervention : CPAP active
Arm Title
Group IIb
Arm Type
Experimental
Arm 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.
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
AHI/h > 30. Intervention : CPAP active
Intervention Type
Device
Intervention Name(s)
CPAP active
Intervention Description
CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg
Intervention Type
Device
Intervention Name(s)
CPAP placebo
Intervention Description
CPAP PR1 Philips Respironics with a constant pression of 4 mm Hg.
Primary Outcome Measure Information:
Title
Number of patients from group IIa and IIb with decreased seizure frequency
Description
Decreased > 50% after CPAP treatment
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Number of patients from group IIa and IIb with decreased seizure frequency
Description
Decreased > 50% after CPAP treatment
Time Frame
At 6 months ; At 12 months
Title
Number of patients from group III with decreased seizure frequency
Description
Decreased > 50% after CPAP treatment
Time Frame
At 3 months ; At 6 months ; At 12 months
Title
Impact of AHI on the number of night seizures
Description
Does the AHI has an impact on the number of night seizure?
Time Frame
At 12 months
Title
Impact of the localisation and the type of epilepsy based on patient medical history exam (video-electroencephalogram) on the SAS risk
Description
Does the AHI is impacted by the localisation and the type of epilepsy?
Time Frame
At 12 months
Title
Number of seizures based on the seizures diary
Description
Impact of SAS treatment on the pharmacoresistance
Time Frame
At 12 months
Title
Number of patients who became drug-susceptible based on the seizures diary
Description
Impact of SAS treatment on the pharmacoresistance
Time Frame
At 3 months ; At 6 months ; At 12 months
Title
Quality of life questionnaire (QOLIE 31)
Description
Impact of SAS treatment on the quality of life
Time Frame
At 3 months ; At 6 months ; At 12 months
Title
Anxiety and depression questionnaire (BECK)
Description
Impact of SAS treatment on anxiety and depression
Time Frame
At 3 months ; At 6 months ; At 12 months
Title
Somnolence questionnaire (Epworth)
Description
Impact of SAS treatment on somnolence
Time Frame
At 3 months ; At 6 months ; At 12 months
Title
Cognitive capacity questionnaire (MOCA)
Description
Impact of SAS treatment on cognitive capacity questionnaire
Time Frame
At 3 months ; At 6 months ; At 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe DERAMBURE, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique
City
Lille
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy
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