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

NCT03200769 | Completed DMC

• 2 other identifiers: 2012_662013-A01156-39
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndromes; Epilepsies, Partial

Keywords

CPAP; Sleep Apnea Syndrome; Pharmacoresistant Epilepsy; Apnea Hypopnea-Index

Outcome Measures

Primary Outcomes (1)

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

  Decreased \> 50% after CPAP treatment

  At 3 months

Secondary Outcomes (10)

• 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

• Impact of AHI on the number of night seizures

  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

• Number of seizures based on the seizures diary

  At 12 months

Study Arms (4)

Group I

NO INTERVENTION

AHI/h \< 15

Group IIa

EXPERIMENTAL

15 \< AHI/h \< 30. Randomization group. Intervention : CPAP active

Device: CPAP active

Group IIb

EXPERIMENTAL

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

Group III

ACTIVE COMPARATOR

AHI/h \> 30. Intervention : CPAP active

Device: CPAP active

Interventions

CPAP active DEVICE

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

Group III; Group IIa

CPAP placebo DEVICE

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

Group IIb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

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

Lille, 59037, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Epilepsies, Partial

Condition Hierarchy (Ancestors)

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

Study Officials

• Philippe DERAMBURE, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 27, 2017
• Study Start: July 21, 2014
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

FR (1)