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

Sleep Apnea Syndromes Clinical Trial

— SASER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200769
• Other study ID #: 2012_66
• Secondary ID: 2013-A01156-39
• Status: Completed
• Phase: N/A
• Start date: July 21, 2014
• Est. completion date: July 2021

Study information

• Verified date: September 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Epilepsies, Partial
• Epilepsy
• Sleep Apnea Syndromes
• Syndrome

Intervention

Device:
• CPAP active
CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg
• CPAP placebo
CPAP PR1 Philips Respironics with a constant pression of 4 mm Hg.

Locations

Country	Name	City	State
France	CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients from group IIa and IIb with decreased seizure frequency	Decreased > 50% after CPAP treatment	At 3 months
Secondary	Number of patients from group IIa and IIb with decreased seizure frequency	Decreased > 50% after CPAP treatment	At 6 months ; At 12 months
Secondary	Number of patients from group III with decreased seizure frequency	Decreased > 50% after CPAP treatment	At 3 months ; At 6 months ; At 12 months
Secondary	Impact of AHI on the number of night seizures	Does the AHI has an impact on the number of night seizure?	At 12 months
Secondary	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?	At 12 months
Secondary	Number of seizures based on the seizures diary	Impact of SAS treatment on the pharmacoresistance	At 12 months
Secondary	Number of patients who became drug-susceptible based on the seizures diary	Impact of SAS treatment on the pharmacoresistance	At 3 months ; At 6 months ; At 12 months
Secondary	Quality of life questionnaire (QOLIE 31)	Impact of SAS treatment on the quality of life	At 3 months ; At 6 months ; At 12 months
Secondary	Anxiety and depression questionnaire (BECK)	Impact of SAS treatment on anxiety and depression	At 3 months ; At 6 months ; At 12 months
Secondary	Somnolence questionnaire (Epworth)	Impact of SAS treatment on somnolence	At 3 months ; At 6 months ; At 12 months
Secondary	Cognitive capacity questionnaire (MOCA)	Impact of SAS treatment on cognitive capacity questionnaire	At 3 months ; At 6 months ; At 12 months