Effect of Auditory Stimulation on Spike Waves in Sleep (ECLASS)

University of Zurich (UZH)

Status: Completed

Conditions: Epilepsy; Sleep

Treatments: Device: Acoustic pulses

Study type: Interventional

Funder types: Other

Identifiers

NCT02562885

SW2015

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Acoustic pulses

Experimental group

Description:

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.

Treatment:

Device: Acoustic pulses