Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
36 participants
INTERVENTIONAL
2017-08-17
2028-11-21
Brief Summary
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Detailed Description
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2. 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.
3. 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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Acoustic 1Hz Stimulation
1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.
Acoustic 1Hz Stimulation
1Hz acoustic pulses delivered during sleep via headphones
Sham Background Noise
Background noise applied via headphones and downloadable phone application during sleep every night.
Sham Background Noise
Background Noise used as a control
Baseline Seizure Monitoring
No use of sound system; Patients record seizures in a diary.
No interventions assigned to this group
Interventions
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Acoustic 1Hz Stimulation
1Hz acoustic pulses delivered during sleep via headphones
Sham Background Noise
Background Noise used as a control
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* MOCA ≥26
* Fluent in English
* Frequent nocturnal IEDs (≥ 10% of the sleep record)
* Frequent nocturnal seizures (≥1 per week)
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Anli Liu
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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17-00698
Identifier Type: -
Identifier Source: org_study_id
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