Acoustic Stimulation for Seizure Suppression

Sponsor

NYU Langone Health (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03198494

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Other: Acoustic 1Hz Stimulation Other: Sham Background Noise	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression

Actual Study Start Date :

Aug 17, 2017

Anticipated Primary Completion Date :

Aug 17, 2022

Anticipated Study Completion Date :

Aug 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acoustic 1Hz Stimulation 1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.	Other: Acoustic 1Hz Stimulation 1Hz acoustic pulses delivered during sleep via headphones
Sham Comparator: Sham Background Noise Background noise applied via headphones and downloadable phone application during sleep every night.	Other: Sham Background Noise Background Noise used as a control
No Intervention: Baseline Seizure Monitoring No use of sound system; Patients record seizures in a diary.

Arm

Intervention/Treatment

Experimental: Acoustic 1Hz Stimulation

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

Other: Acoustic 1Hz Stimulation

1Hz acoustic pulses delivered during sleep via headphones

Sham Comparator: Sham Background Noise

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

Other: Sham Background Noise

Background Noise used as a control

No Intervention: Baseline Seizure Monitoring

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

Outcome Measures

Primary Outcome Measures

Successful System Training [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 [72 hours]
IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG
System Adherence [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 Outcome Measures

System Use effect on Features of Sleep [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.
Seizure Control [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Anli Liu, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03198494

Other Study ID Numbers:

17-00698

First Posted:

Jun 26, 2017

Last Update Posted:

Feb 9, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Seizures

Study Results

No Results Posted as of Feb 9, 2022