Effect of Auditory Stimulation on Spike Waves in Sleep

NCT ID: NCT02562885

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-12-31

Brief Summary

Background: Close relationship exists between sleep slow wave (SSW) and the generation of spike wave in NREM-sleep. SSW are cortically generated oscillations alternating between excitatory depolarization ("Up-phase" of the SSW) and inhibitory hyperpolarization ("Down-phase" of the SSW). It has been shown experimentally that with increasing synchrony of slow neuronal oscillations SSW turn into spike waves. Acoustic pulses applied in correspondence to the SSW "Up-phase" enhance the amplitude of the subsequent SSW. Conversely, tones delivered at the SSW "Downphase" have a disruptive effect on the following SSW.

Participants: Patients with epilepsy and spike waves in NREM-sleep.

Objective: Modification of spike wave frequency, amplitude and spreading during NREM sleep by acoustic pulses applied at the "Up-" or "Down-phase" of SSW.

Conditions

Epilepsy; Sleep

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Acoustic pulses

During NREM sleep:

1. 15 minutes without acoustic pulses

2. 15 minutes with acoustic pulses

3. 15 minutes without acoustic pulses

Two different protocols are applied:

(A) tone application at the "Down-phase" of sleep slow wave (SSW) (B) tone application at the "Up-phase" of SSW.

Participants with Rolandic epilepsy/BECTS or generalized spike waves: Protocol A and B alternatingly.

Participants with ESES/CSWS: only Protocol A.

Group Type: EXPERIMENTAL

Acoustic pulses

Intervention Type: DEVICE

Acoustic pulses applied during NREM sleep slow waves "Up-phase" or "Down-phase". The acoustic stimulus will be delivered by speakers with a volume of about 50 dB.

Interventions

Acoustic pulses

Acoustic pulses applied during NREM sleep slow waves "Up-phase" or "Down-phase". The acoustic stimulus will be delivered by speakers with a volume of about 50 dB.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Participants with Rolandic epilepsy/BECTS
• Participants with ESES/CSWS
• Participants with generalized spike waves in sleep
• EEG within 6 months before study night consistent with the diagnosis

Exclusion Criteria

• Clinically significant concomitant acute or chronic disease
• Seizure frequency >1/week, history of convulsive status epilepticus or seizures provoked by sleep deprivation
• Severe sleep problems
• Treatment with corticosteroids, immunosuppressive or vagus nerve stimulation

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernhard Schmitt, MD

Role: PRINCIPAL_INVESTIGATOR

Div. of Clinical Neurophysiology/Epilepsy, University Children's Hospital, Steinwiesstrasse 75, CH-8032 Zurich

Locations

Div. of Clinical Neurophysiology/Epilepsy, University Children's Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

SW2015

Identifier Type: -

Identifier Source: org_study_id