Back to resultsAcoustic Stimulation for Seizure Suppression
Primary Purpose
Epilepsy
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acoustic 1Hz Stimulation
Sham Background Noise
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
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 Exclusion Criteria for Aim 3
- No medication changes at least 1 month before study, and during 3 months of study activities
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Acoustic 1Hz Stimulation
Sham Background Noise
Baseline Seizure Monitoring
Arm Description
1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.
Background noise applied via headphones and downloadable phone application during sleep every night.
No use of sound system; Patients record seizures in a diary.
Outcomes
Primary Outcome Measures
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.
Interictal Discharge frequency
IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG
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
Secondary Outcome Measures
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.
Seizure 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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03198494
Brief Title
Acoustic Stimulation for Seizure Suppression
Official Title
Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 17, 2017 (Actual)
Primary Completion Date
December 17, 2024 (Anticipated)
Study Completion Date
December 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acoustic 1Hz Stimulation
Arm Type
Experimental
Arm Description
1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.
Arm Title
Sham Background Noise
Arm Type
Sham Comparator
Arm Description
Background noise applied via headphones and downloadable phone application during sleep every night.
Arm Title
Baseline Seizure Monitoring
Arm Type
No Intervention
Arm Description
No use of sound system; Patients record seizures in a diary.
Intervention Type
Other
Intervention Name(s)
Acoustic 1Hz Stimulation
Intervention Description
1Hz acoustic pulses delivered during sleep via headphones
Intervention Type
Other
Intervention Name(s)
Sham Background Noise
Intervention Description
Background Noise used as a control
Primary Outcome Measure Information:
Title
Successful System Training
Description
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.
Time Frame
72 hours
Title
Interictal Discharge frequency
Description
IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG
Time Frame
72 hours
Title
System Adherence
Description
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
Time Frame
2 months
Secondary Outcome Measure Information:
Title
System Use effect on Features of Sleep
Description
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.
Time Frame
72 hours
Title
Seizure Control
Description
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).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria for Aim 3
No medication changes at least 1 month before study, and during 3 months of study activities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anli Liu
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Acoustic Stimulation for Seizure Suppression
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