Skip to content

Effect of Auditory Stimulation on Spike Waves in Sleep

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02562885
Acronym
ECLASS
Enrollment
6
Registered
2015-09-29
Start date
2015-10-31
Completion date
2016-12-31
Last updated
2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Sleep

Keywords

Benign epilepsy with centro-temporal spikes, Continuous spike waves in slow wave sleep, Electroencephalography, Sleep, slow wave

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.

Interventions

DEVICEAcoustic 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.

Sponsors

University Children's Hospital, Zurich
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Spike wave indexChange baseline (without) and with acoustic pulses in the same NREM period: 45 minutesChange 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

MeasureTime frameDescription
Spike wave amplitudeChange baseline (without) and with acoustic pulses in the same NREM period: 45 minutesChange 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.
Spike wave spreadingChange baseline (without) and with acoustic pulses in the same NREM period: 45 minutesChange 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.
Spike wave index in the NREM (2) period following the NREM (1) period with acoustic pulsesChange baseline (NREM 1) and NREM 2: expected average of 1 hourChange 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 .
Spike wave amplitude in the NREM (2) period following the NREM (1) period with acoustic pulsesChange baseline (NREM 1) and NREM 2: expected average of 1 hourChange 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.
Spike wave spreading in the NREM (2) period following the NREM (1) period with acoustic pulsesChange baseline (NREM 1) and NREM 2: expected average of 1 hourChange 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026