EpilepsyNCT03198494
Acoustic Stimulation for Seizure Suppression
A study testing Acoustic 1Hz Stimulation in people with Epilepsy, run by NYU Langone Health at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Acoustic 1Hz Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2017to 21 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression
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
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Acoustic 1Hz Stimulation, Sham Background Noise
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic 1Hz StimulationOther
1Hz acoustic pulses delivered during sleep via headphones
Sham Background NoiseOther
Background Noise used as a control
| Study group | Role | What they receive |
|---|---|---|
| Acoustic 1Hz Stimulation | Experimental | 1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night. Receives: Other: Acoustic 1Hz Stimulation |
| Sham Background Noise | Sham comparator | Background noise applied via headphones and downloadable phone application during sleep every night. Receives: Other: Sham Background Noise |
| Baseline Seizure Monitoring | No intervention | No use of sound system; Patients record seizures in a diary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Interictal Discharge frequency
IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG
Measured: 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
Measured: 2 months
Secondary outcomes (2)
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.
Measured: 72 hours
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start17 Aug 2017
- Primary completion21 Nov 2028 (estimated)
- Study completion21 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anli Liu, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198494
- Sponsor's protocol ID
- 17-00698
- Status last verified
- Feb 2026
- First submitted
- 16 Jun 2017
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression
- ClinicalTrials.gov ID
- NCT03198494
- Acronym / sponsor ID
- 17-00698
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 21 Nov 2028 (estimated)
- Study completion
- 21 Nov 2028 (estimated)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acoustic 1Hz Stimulation | Experimental | Other: Acoustic 1Hz Stimulation1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night. |
| Sham Background Noise | Sham comparator | Other: Sham Background NoiseBackground 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-60 years old
- Able to provide informed consent
- MOCA ≥26
- Fluent in English
- Frequent nocturnal IEDs (≥ 10% of the sleep record)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic 1Hz Stimulation1Hz acoustic pulses delivered during sleep via headphones | Other | Acoustic 1Hz Stimulation |
| Sham Background NoiseBackground Noise used as a control | Other | Sham Background Noise |
Primary outcome
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
2 secondary outcomes
System Use effect on Features of Sleep
Time frame: 72 hours
Seizure Control
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anli Liu principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic 1Hz Stimulation in people with Epilepsy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful System Training (time frame: 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.