EpilepsyECLASSNCT02562885
Effect of Auditory Stimulation on Spike Waves in Sleep
A study testing Acoustic pulses in people with Epilepsy and Sleep, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 12 years
- What is being tested?
- Acoustic pulses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Div. of Clinical Neurophysiology/Epilepsy, University Children's Hospital Zurich
Zurich, CH-8032
About this study
Official title: Effect of Closed-loop Auditory Stimulation on Spike Waves During Slow Wave Sleep, an Open Label Pilot Study
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.
- Being tested
- Acoustic pulses
- Keywords
- Benign epilepsy with centro-temporal spikes, Continuous spike waves in slow wave sleep, Electroencephalography, Sleep, slow wave
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Acoustic pulses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes
Secondary outcomes (5)
Spike wave amplitude
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.
Measured: Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes
Spike wave spreading
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.
Measured: 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 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 .
Measured: 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 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.
Measured: 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 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.
Measured: Change baseline (NREM 1) and NREM 2: expected average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernhard Schmitt, MD, Principal investigator, Div. of Clinical Neurophysiology/Epilepsy, University Children's Hospital, Steinwiesstrasse 75, CH-8032 Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562885
- Sponsor's protocol ID
- SW2015
- Acronym
- ECLASS
- Status last verified
- Dec 2016
- First submitted
- 21 Sep 2015
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Closed-loop Auditory Stimulation on Spike Waves During Slow Wave Sleep, an Open Label Pilot Study
- ClinicalTrials.gov ID
- NCT02562885
- Acronym / sponsor ID
- ECLASS / SW2015
- Keywords
- Benign epilepsy with centro-temporal spikes, Continuous spike waves in slow wave sleep, Electroencephalography, Sleep, slow wave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acoustic pulses | Experimental | Device: Acoustic pulsesDuring 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic pulsesAcoustic 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. | Device | Acoustic pulses |
Primary outcome
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.
5 secondary outcomes
Spike wave amplitude
Time frame: Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes
Spike wave spreading
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change baseline (NREM 1) and NREM 2: expected average of 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Schmitt, MD principal investigator
Div. of Clinical Neurophysiology/Epilepsy, University Children's Hospital, Steinwiesstrasse 75, CH-8032 Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic pulses in people with Epilepsy and Sleep, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spike wave index (time frame: Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.