NCT03200769CompletedNot Applicable
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy
University Hospital, Lille2 sites in 1 country103 target enrollmentStarted: July 21, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 103
- Locations
- 2
- Primary Endpoint
- Number of patients from group IIa and IIb with decreased seizure frequency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female age ≥
- •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 ≥
- •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.
Outcomes
Primary Outcomes
Number of patients from group IIa and IIb with decreased seizure frequency
Time Frame: At 3 months
Decreased \> 50% after CPAP treatment
Secondary Outcomes
- Cognitive capacity questionnaire (MOCA)(At 3 months ; At 6 months ; At 12 months)
- Impact of the localisation and the type of epilepsy based on patient medical history exam (video-electroencephalogram) on the SAS risk(At 12 months)
- Anxiety and depression questionnaire (BECK)(At 3 months ; At 6 months ; At 12 months)
- Impact of AHI on the number of night seizures(At 12 months)
- Number of seizures based on the seizures diary(At 12 months)
- Somnolence questionnaire (Epworth)(At 3 months ; At 6 months ; At 12 months)
- Number of patients who became drug-susceptible based on the seizures diary(At 3 months ; At 6 months ; At 12 months)
- Quality of life questionnaire (QOLIE 31)(At 3 months ; At 6 months ; At 12 months)
- Number of patients from group IIa and IIb with decreased seizure frequency(At 6 months ; At 12 months)
- Number of patients from group III with decreased seizure frequency(At 3 months ; At 6 months ; At 12 months)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Effect of Continuous Positive Airway Pressure (CPAP) Treatment in the Control of Refractory HypertensionSleep ApneaHypertensionNCT00616265Sociedad Española de Neumología y Cirugía Torácica210
Completed
Not Applicable
The CPAP Effect in Severe Obstructive- Sleep- Apnea Patients Without Daytime Sleepiness: A Control Randomized TrialSleep Apnea, ObstructiveNCT00491088National Taiwan University Hospital96
Terminated
Not Applicable
Juno Perth Clinical TrialRespiratory InsufficiencyObesity Hypoventilation SyndromeChronic Obstructive Pulmonary Disease (COPD)Neuromuscular DiseaseUpper Airway ObstructionNCT02317042ResMed25
Completed
Not Applicable
Effect of CPAP (Continuous Positive Airway Pressure) on Lung Function in Asthmatics With Sleep ApneaSleep ApneaAsthmaNCT00238069National Jewish Health20
Completed
Not Applicable
Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation AblationObstructive Sleep ApneaCardiac ArrhythmiasAtrial FibrillationNCT02332096Beth Israel Deaconess Medical Center130