NCT02562885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 13, 2017

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

September 21, 2015

Last Update Submit

January 12, 2017

Conditions

EpilepsySleep

Keywords

Benign epilepsy with centro-temporal spikesContinuous spike waves in slow wave sleepElectroencephalographySleep, slow wave

Outcome Measures

Primary Outcomes (1)

  • Spike wave index

    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.

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

Secondary Outcomes (5)

  • Spike wave amplitude

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

  • Spike wave spreading

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

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

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

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

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

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

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

Study Arms (1)

Acoustic pulses

EXPERIMENTAL

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

Interventions

Acoustic pulsesDEVICE

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.

Acoustic pulses

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Zurich, CH-8032, Switzerland

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Bernhard Schmitt, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 29, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 13, 2017

Record last verified: 2016-12

Locations

CH(1)