Acoustic Stimulation for Seizure Suppression

NCT03198494 | Active Not Recruiting

• 1 other identifier: 17-00698
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• 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.

  72 hours

• Interictal Discharge frequency

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

  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

  2 months

Secondary Outcomes (2)

• System Use effect on Features of Sleep

  72 hours

• Seizure Control

  3 months

Study Arms (3)

Acoustic 1Hz Stimulation

EXPERIMENTAL

1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.

Other: Acoustic 1Hz Stimulation

Sham Background Noise

SHAM COMPARATOR

Background noise applied via headphones and downloadable phone application during sleep every night.

Other: Sham Background Noise

Baseline Seizure Monitoring

NO INTERVENTION

No use of sound system; Patients record seizures in a diary.

Interventions

Acoustic 1Hz Stimulation OTHER

1Hz acoustic pulses delivered during sleep via headphones

Acoustic 1Hz Stimulation

Sham Background Noise OTHER

Background Noise used as a control

Sham Background Noise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Able to provide informed consent
• MOCA ≥26
• Fluent in English
• Frequent nocturnal IEDs (≥ 10% of the sleep record)
• Frequent nocturnal seizures (≥1 per week)

You may not qualify if:

• 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
• No medication changes at least 1 month before study, and during 3 months of study activities

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anli Liu

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 26, 2017
• Study Start: August 17, 2017
• Primary Completion (Estimated): November 21, 2028
• Study Completion (Estimated): November 21, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)