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Completed

NCT Number: NCT02562885

Effect of Auditory Stimulation on Spike Waves in Sleep

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Sleep

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Zurich, CH-8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acoustic pulses

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.

Primary outcomes

  1. Spike wave index

    Time frame: Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes

    Change of spike wave index during acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Spike wave index given in percent and calculated by number of seconds within 10 second windows with spike waves over the whole 15 minutes of the block design part.

Secondary outcomes

  1. Spike wave amplitude

    Time frame: Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes

    Change of spike wave amplitude (in microvolts) during acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Amplitudes of maximum spike will be analyzed in 10 seconds periods of the first and the last 100 seconds of every part of the block design. EEG source derivation will be used for the analysis. The mean of the 3 highest amplitudes of each 10 seconds period will be determined and the mean of the 10 periods will presented in mean and SD.

  2. Spike wave spreading

    Time frame: Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes

    Change of spike wave spreading during acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Spreading will be analyzed in 10 seconds periods of the first and the last 100 seconds of every part of the block design. EEG source derivation will be used for the analysis. Maximum spike wave spreading (number of electrodes involved) visible in 3 spike waves of each 10 second period will be determined and the mean of the 10 periods will presented in mean and SD.

  3. Spike wave index in the NREM (2) period following the NREM (1) period with acoustic pulses

    Time frame: Change baseline (NREM 1) and NREM 2: expected average of 1 hour

    Change of spike wave index in the NREM period following the NREM period with acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Over the first 15 minutes of the following NREM period: Spike wave index given in percent and calculated by number of seconds within 10 second windows with spike waves .

  4. Spike wave amplitude in the NREM (2) period following the NREM (1) period with acoustic pulses

    Time frame: Change baseline (NREM 1) and NREM 2: expected average of 1 hour

    Change of spike wave amplitude (in microvolts) in the NREM period following the NREM period with acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Amplitudes of maximum spike will be analyzed in 10 seconds periods of the first and the last 100 seconds of the following NREM period. EEG source derivation will be used for the analysis. The mean of the 3 highest amplitudes of each 10 seconds period will be determined and the mean of the 10 periods will presented in mean and SD.

  5. Spike wave spreading in the NREM (2) period following the NREM (1) period with acoustic pulses

    Time frame: Change baseline (NREM 1) and NREM 2: expected average of 1 hour

    Change of spike wave spreading in the NREM period following the NREM period with acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Spreading will be analyzed in 10 seconds periods of the first and the last 100 seconds of the following NREM period. EEG source derivation will be used for the analysis. Maximum spike wave spreading (number of electrodes involved) visible in 3 spike waves of each 10 second period will be determined and the mean of the 10 periods will presented in mean and SD.

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

Effect of Closed-loop Auditory Stimulation on Spike Waves During Slow Wave Sleep, an Open Label Pilot Study

Acronym: ECLASS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2015
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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