Clinical trial NCT02562885: Effect of Auditory Stimulation on Spike Waves in Sleep
Official title: Effect of Closed-loop Auditory Stimulation on Spike Waves During Slow Wave Sleep, an Open Label Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Sleep
Keywords: Benign epilepsy with centro-temporal spikes
Continuous spike waves in slow wave sleep
Electroencephalography
Sleep, slow wave
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 6
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Spike wave index
timeFrame: Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes
Secondary outcomes:
measure: Spike wave amplitude
timeFrame: Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes
measure: Spike wave spreading
timeFrame: Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes
measure: Spike wave index in the NREM (2) period following the NREM (1) period with acoustic pulses
timeFrame: Change baseline (NREM 1) and NREM 2: expected average of 1 hour
measure: Spike wave amplitude in the NREM (2) period following the NREM (1) period with acoustic pulses
timeFrame: Change baseline (NREM 1) and NREM 2: expected average of 1 hour
measure: Spike wave spreading in the NREM (2) period following the NREM (1) period with acoustic pulses
timeFrame: Change baseline (NREM 1) and NREM 2: expected average of 1 hour
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Div. of Clinical Neurophysiology/Epilepsy, University Children's Hospital Zurich
Study officials:
affiliation: Div. of Clinical Neurophysiology/Epilepsy, University Children's Hospital, Steinwiesstrasse 75, CH-8032 Zurich
name: Bernhard Schmitt, MD
role: PRINCIPAL_INVESTIGATOR
References: