Acoustic Stimulation for Seizure Suppression
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|ClinicalTrials.gov Identifier: NCT03198494|
Recruitment Status : Enrolling by invitation
First Posted : June 26, 2017
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Other: Acoustic 1Hz Stimulation Other: Sham Background Noise||Not Applicable|
- To test the feasibility of wearing an earphone system delivering acoustic stimulation during a night of sleep in adult epilepsy patients monitored in an inpatient unit.
- To determine the acute physiological effects of low-frequency acoustic stimulation on interictal epileptiform discharge (IED) frequency during NREM sleep in adult patients with epilepsy in an ambulatory setting.
- To determine the feasibility of applying low-frequency acoustic stimulation in a long-term home setting in adult epilepsy patients with frequent nocturnal seizures.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression|
|Actual Study Start Date :||August 17, 2017|
|Estimated Primary Completion Date :||August 17, 2021|
|Estimated Study Completion Date :||August 17, 2021|
Experimental: Acoustic 1Hz Stimulation
1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.
Other: Acoustic 1Hz Stimulation
1Hz acoustic pulses delivered during sleep via headphones
Sham Comparator: Sham Background Noise
Background noise applied via headphones and downloadable phone application during sleep every night.
Other: Sham Background Noise
Background Noise used as a control
No Intervention: Baseline Seizure Monitoring
No use of sound system; Patients record seizures in a diary.
- Successful System Training [ Time Frame: 72 hours ]Assessment of how well participants learn to use stimulation smart-phone application and headphones, defined as the percentage of subjects with correctly maintained earphones during the first four hours of nocturnal sleep in the first days of use.
- Interictal Discharge frequency [ Time Frame: 72 hours ]IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG
- System Adherence [ Time Frame: 2 months ]Percentage of nights during which patients were compliant with the acoustic stimulation device during two months of home use (1 month control acoustic condition, 1 month 1Hz stimulation) determined weekly by patient self-report
- System Use effect on Features of Sleep [ Time Frame: 72 hours ]Effect of system use on sleep features, including time spent in each stage of sleep, delta and spindle power and spatial distribution gather from EEG.
- Seizure Control [ Time Frame: 3 months ]Seizure frequency during control and treatment months gathered from seizure diary and IED frequency gathered from EEG (1 month baseline, 1 month sham stimulation, 1 month 1Hz stimulation).
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): NCT03198494
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Anli Liu||NYU Langone Health|