Epilepsy
Conditions
Brief summary
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
Detailed description
1. 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. 2. 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. 3. To determine the feasibility of applying low-frequency acoustic stimulation in a long-term home setting in adult epilepsy patients with frequent nocturnal seizures.
Interventions
OTHERAcoustic 1Hz Stimulation
1Hz acoustic pulses delivered during sleep via headphones
OTHERSham Background Noise
Background Noise used as a control
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 18-60 years old * Able to provide informed consent * MOCA ≥26 * Fluent in English * Frequent nocturnal IEDs (≥ 10% of the sleep record) * Monitored on the adult epilepsy monitoring unit (EMU, for Aim 1 only) Additional inclusion criteria for Aim 3 * Frequent nocturnal seizures (≥1 per week)
Exclusion criteria
* Hearing impairment * Diagnosis of a sleep disorder (sleep apnea, periodic limb movements of sleep, or other medical conditions with frequent arousals) * Psychoactive medication use (other than AEDs, for example SSRIs, antipsychotics, BDZ, or stimulants) * Seizures ≤ 24 hours prior to study. * Alcohol or recreational drug use in the 24 hours prior to the study * BMI ≥ 30 * MOCA \<26 * History of recent travel across time zones within the 1 month prior to study activities * Shift work for 1 month prior to study activities Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful System Training | 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 | 72 hours | IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG |
| System Adherence | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Use effect on Features of Sleep | 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 | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnli Liu
NYU Langone Health
Outcome results
None listed