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Enrolling by invitationNCT04788628Updated Nov 17, 2025

Auditory Stimulation Effects on Sleep and Memory in Patients With Epilepsy

An interventional study of Baseline and Motor procedural memory task in Epilepsy, sponsored by Massachusetts General Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
12 Years to 65 Years
Sex
All
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Study summary

This study will investigate the role of coordinated brain rhythms during sleep in memory consolidation and determine whether playing precisely timed brief bursts of noise can enhance these rhythms and improve memory in epilepsy inpatients with implanted hippocampal electrodes.

Read the detailed description

The investigators will test the hypotheses that coordinated brain rhythms during nonrapid eye movement sleep are associated with memory consolidation and can be enhanced with auditory stimulation (playing precisely timed brief bursts of quiet noise) to improve memory. The investigators will measure differences in sleep and memory performance in epilepsy inpatients with implanted hippocampal electrodes and continuous full scalp EEG monitoring under three overnight sleep conditions: a baseline night; a memory night during which sleep-dependent memory consolidation is assessed with the finger tapping motor sequence task (MST) with training prior to sleep and testing the next morning; and a stimulation night during which participants train on the MST, have precisely timed auditory stimulation during the sleep that follows, and are tested on the MST in the morning.

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Conditions studied

  • Epilepsy

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Keywords

  • Sleep
  • Memory
  • Auditory stimulation
  • Spindles
  • Intracranial monitoring
  • Hippocampal ripples
  • Slow oscillations
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In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 24 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Inpatients with epilepsy
  • Aged 12-65
  • Undergoing clinically indicated continuous scalp and intracranial EEG monitoring with implanted hippocampal electrodes
  • Fluent in English
  • Able to give informed consent/assent (for minors aged 12-17 or adults with an appointed guardian)

Exclusion criteria

Exclusion Criteria:

  • Intellectual disability impairing ability to perform task
  • Motor problems that preclude finger tapping task
  • Previous surgery anticipated to disrupt coordination of sleep oscillations in the circuitry of interest
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Epilepsy inpatients

    Epilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring

    Other: Baseline · Other: Motor procedural memory task · Other: Motor procedural memory task plus auditory stimulation

Interventions

  • OtherBaseline

    Hippocampal and scalp EEG monitoring during overnight sleep

  • OtherMotor procedural memory task

    Training on the finger tapping MST prior to monitored overnight sleep with MST testing the following morning

  • OtherMotor procedural memory task plus auditory stimulation

    Training on the finger tapping MST prior to monitored overnight sleep that includes auditory stimulation, with MST testing the following morning

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What researchers measure

Primary outcomes

  1. Changes in slow oscillation-spindle-hippocampal ripple coupling

    Changes in the coupling of slow oscillations with spindles and hippocampal ripples during non-Rapid Eye Movement (NREM) sleep as measured by scalp and intracranial EEG between baseline, memory, and auditory stimulation nights.

    Time frame: Three nights of sleep within three weeks

Secondary outcomes

  1. Changes in sleep-dependent consolidation of motor procedural memory

    Changes in sleep-dependent improvement of motor procedural memory performance on the finger tapping motor sequence task (MST) between baseline, memory, and auditory stimulation nights. Different sequences are employed for the memory and auditory stimulation nights in a counter-balanced order.

    Time frame: Three nights of sleep within three weeks

  2. Changes in slow oscillations

    Changes in slow oscillations during non-rapid eye movement (NREM) sleep as measured by EEG between the baseline, memory, and auditory stimulation nights

    Time frame: Three nights of sleep within three weeks

  3. Changes in sleep spindles

    Changes in sleep spindles during non-rapid eye movement (NREM) sleep as measured by EEG between baseline, memory, and auditory stimulation nights

    Time frame: Three nights of sleep within three weeks

  4. Changes in hippocampal ripples

    Changes in hippocampal ripples during non-rapid eye movement (NREM) sleep as measured by intracranial EEG between baseline, memory, and auditory stimulation nights

    Time frame: Three nights of sleep within three weeks

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Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
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References and documents

Individual participant data

Plan to share: Yes — The PI will disseminate results through presentations at public lectures, scientific institutions and meetings, and/or publications in major journals. The institution and the PI will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources. Prevailing standards and guidelines in documenting and depositing data sets will be followed. Specifically, quality-controlled data used in publications will be deidentified and made available to requesting scientists, starting one year following the completion of the project. Workflows will be documented and will allow any external groups to reproduce results from the raw data. The PI will be responsible for overseeing the sharing the data. Raw and summary data will be submitted to the appropriate NIMH Data Archive annually, including The National Database for Clinical Trials Related to Mental Illness (NDCT).

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04788628
Lead sponsor
Massachusetts General Hospital
Responsible party
Dara S. Manoach, PhD (Professor, Massachusetts General Hospital) — Principal investigator
First posted
Mar 9, 2021
Start date
Jan 21, 2021
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Nov 17, 2025

Study contacts

Dara Manoach, PhD
principal investigator · Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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