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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562885
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich

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.


Condition or disease Intervention/treatment Phase
Epilepsy Sleep Device: Acoustic pulses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Closed-loop Auditory Stimulation on Spike Waves During Slow Wave Sleep, an Open Label Pilot Study
Study Start Date : October 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: 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.

Device: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562885


Locations
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Switzerland
Div. of Clinical Neurophysiology/Epilepsy, University Children's Hospital Zurich
Zurich, Switzerland, CH-8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
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Principal Investigator: Bernhard Schmitt, MD Div. of Clinical Neurophysiology/Epilepsy, University Children's Hospital, Steinwiesstrasse 75, CH-8032 Zurich
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Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT02562885    
Other Study ID Numbers: SW2015
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: December 2016
Keywords provided by University Children's Hospital, Zurich:
Benign epilepsy with centro-temporal spikes
Continuous spike waves in slow wave sleep
Electroencephalography
Sleep, slow wave
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases