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The objective of this study is to test the feasibility and physiological effect of low-frequency (1 Hz) acoustic stimulation delivered during nocturnal NREM sleep in epilepsy patients. The long-term goal is to develop this protocol for daily, long-term use in a home setting, for nocturnal seizure and IED suppression
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acoustic 1Hz Stimulation | Experimental | 1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night. |
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| Sham Background Noise | Sham Comparator | Background noise applied via headphones and downloadable phone application during sleep every night. |
|
| Baseline Seizure Monitoring | No Intervention | No use of sound system; Patients record seizures in a diary. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acoustic 1Hz Stimulation | Other | 1Hz acoustic pulses delivered during sleep via headphones |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful System Training | 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. | 72 hours |
| Interictal Discharge frequency | IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG | 72 hours |
| System Adherence | 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 | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| System Use effect on Features of Sleep | 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. | 72 hours |
| Seizure Control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anli Liu | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham Background Noise | Other | Background Noise used as a control |
|
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).
| 3 months |