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Behavioural Intervention
Acoustic Stimulation for Epilepsy
N/A
Waitlist Available
Led By Anli Liu
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Additional inclusion criteria for Aim 3: Frequent nocturnal seizures (≥1 per week)
Age 18-60 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trialtests if sound waves can reduce seizures and abnormal brain activity during sleep for epilepsy patients. Goal is to use in home for long-term.
Who is the study for?
This trial is for adults aged 18-60 with epilepsy, who experience frequent nocturnal seizures or disturbances in their sleep due to seizure activity. Participants should be fluent in English, have a good cognitive function (MOCA score ≥26), and not be overweight (BMI <30). They shouldn't have hearing issues, sleep disorders, recent travel across time zones, shift work history before the study, or use certain psychoactive medications.Check my eligibility
What is being tested?
The study tests low-frequency acoustic stimulation versus sham noise during night-time sleep to see if it can reduce nighttime seizures and related brain activity. The ultimate goal is to create a home-use protocol for people with epilepsy to suppress seizures during sleep.See study design
What are the potential side effects?
Since this trial involves acoustic stimulation which is non-invasive, side effects are expected to be minimal. However, participants may potentially experience discomfort from the sound or disturbance of their normal sleep patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience seizures at night, at least once a week.
Select...
I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interictal Discharge frequency
Successful System Training
System Adherence
Secondary outcome measures
Seizure Control
System Use effect on Features of Sleep
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Acoustic 1Hz StimulationExperimental Treatment1 Intervention
1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.
Group II: Baseline Seizure MonitoringActive Control1 Intervention
No use of sound system; Patients record seizures in a diary.
Group III: Sham Background NoisePlacebo Group1 Intervention
Background noise applied via headphones and downloadable phone application during sleep every night.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,685 Total Patients Enrolled
25 Trials studying Epilepsy
3,007 Patients Enrolled for Epilepsy
Anli LiuPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience seizures at night, at least once a week.You have a body mass index (BMI) of 30 or higher.My MOCA score is below 26.You have traveled to a different time zone within the past month.I have been diagnosed with a sleep disorder.I am taking medication for mental health that isn't for epilepsy.I am between 18 and 60 years old.I am being monitored in an adult epilepsy unit.You have used alcohol or recreational drugs within 24 hours before the study.You have trouble hearing.You have seizures happening often at night (more than 10% of the time you are asleep).You have worked night shifts in the month before the study starts.You have a MOCA score of 26 or higher.I have not had a seizure in the last 24 hours.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Background Noise
- Group 2: Baseline Seizure Monitoring
- Group 3: Acoustic 1Hz Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I gain admittance to this clinical experiment?
"To be eligible for this trial, potential participants must demonstrate the presence of aura symptoms and fall between 18-60 years old. 36 patients will ultimately partake in the experiment."
Answered by AI
Are individuals below the age of forty acceptable candidates for this research?
"This medical trial has an age range of 18 to 60 years old that must be met in order for a patient to qualify. There are 121 studies related to minors and 191 trials dedicated specifically towards elderly patients aged over 65."
Answered by AI
Is recruitment still open for this research endeavor?
"According to the clinicaltrials.gov database, recruitment for this medical trial has been discontinued since its last edit on October 12th 2022. Nevertheless, there are currently 287 other trials actively searching for participants."
Answered by AI
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