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Active, Not Recruiting

NCT Number: NCT03198494

Acoustic Stimulation 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acoustic 1Hz Stimulation

Other

1Hz acoustic pulses delivered during sleep via headphones

Sham Background Noise

Other

Background Noise used as a control

Primary outcomes

  1. 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.

  2. Interictal Discharge frequency

    Time frame: 72 hours

    IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG

  3. 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

Secondary outcomes

  1. System Use effect on Features of Sleep

    Time frame: 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.

  2. Seizure Control

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2017
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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