Effect of Auditory Stimulation on Spike Waves in Sleep
- Conditions
- EpilepsySleep
- Interventions
- Device: Acoustic pulses
- Registration Number
- NCT02562885
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Acoustic pulses 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.
- Primary Outcome Measures
Name Time Method Spike wave index 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
Name Time Method Spike wave spreading 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.
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 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.
Spike wave amplitude 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.
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 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 .
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 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.
Trial Locations
- Locations (1)
Div. of Clinical Neurophysiology/Epilepsy, University Children's Hospital Zurich
🇨ðŸ‡Zurich, Switzerland