Closed Loop Auditory Stimulus in Sleep and epilepsY

NCT ID: NCT05159609

Last Updated: 2021-12-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-08-31

Brief Summary

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This is a single-centre pilot study of a non-invasive auditory stimulation during sleep in participants with temporal lobe epilepsy.

Detailed Description

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The primary objectives will be to pilot the use of home-based auditory stimulation during sleep in 10-20 participants with temporal lobe epilepsy using wireless devices.

Conditions

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Temporal Lobe Epilepsy

Keywords

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Closed loop auditory stimulus sleep memory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Within subject comparison of stimulus and sham sessions
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
auditory stimulus was played at 0 or 50 decibels during sleep

Study Groups

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Stim First

Participants slept for one night while auditory sounds were played at specific points during slow wave sleep. At least one week later, an identical procedure occured with no acoustic sounds.

Group Type ACTIVE_COMPARATOR

Closed loop auditory stimulus

Intervention Type DEVICE

50ms of low volume pink noise delivered during slow wave sleep

Sham First

Participants slept for one night while no acoustic sounds were played. At least one week later, an identical procedure occured while acoustic sounds were played at specific points during slow wave sleep.

Group Type SHAM_COMPARATOR

Closed loop auditory stimulus

Intervention Type DEVICE

50ms of low volume pink noise delivered during slow wave sleep

Interventions

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Closed loop auditory stimulus

50ms of low volume pink noise delivered during slow wave sleep

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Participant is willing and able to give informed consent
2. Participant diagnosed with temporal lobe epilepsy
3. Will have had fewer than three generalized tonic clonic seizures per month in the last three months
4. Will be taking 3 or fewer anti-seizure medications.
5. Will have access to a computer or cellphone with an internet connection

Exclusion Criteria

1. Abnormal hearing that cannot be corrected to normal overnight.
2. Abnormal vision that cannot be corrected to normal during the day.
3. Unwilling to abstain from caffeine, alcohol, daytime naps and extreme physical exercise in the 12 hours prior to the study.
4. Cannot read English
5. Engaged in night work in the previous 2 months
6. Any history of seizures triggered by music or sounds
7. Travelled across more than 2 time zones in the last 2 months
8. Prescribed/taking sleeping tablets other than clobazam
9. Cannabis use \>4 joints/day.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiff and Vale University Health Board

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khalid Hamandi, MRCP/Phd

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Wales/Cardiff University

Jennifer Roebber, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Wales/Cardiff University

Locations

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Cardiff and Vale UHW, Neurology department, ward C4, video-EEG monitoring unit

Cardiff, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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7796

Identifier Type: -

Identifier Source: org_study_id