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

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 Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Epilepsies, Partial
• Intervention / Treatment: Device: CPAP active; Device: CPAP placebo

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group I; AHI/h < 15
Experimental: Group IIa; 15 < AHI/h < 30. Randomization group. Intervention : CPAP active	Device: CPAP active; CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg
Experimental: Group IIb; 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.	Device: CPAP placebo; CPAP PR1 Philips Respironics with a constant pression of 4 mm Hg.
Active Comparator: Group III; AHI/h > 30. Intervention : CPAP active	Device: CPAP active; CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2014
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: CPAP; Sleep Apnea Syndrome; Pharmacoresistant Epilepsy; Apnea Hypopnea-Index
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Epilepsy; Sleep Apnea Syndromes; Syndrome; Apnea; Epilepsies, Partial
• Other Study ID Numbers: 2012_66; 2013-A01156-39 (Other Identifier: ID-RCB number, ANSM)