Closed Loop Auditory Stimulus in Sleep and epilepsY

NCT05159609 | Completed DMC

• 1 other identifier: 7796
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Temporal Lobe Epilepsy

Keywords

Closed loop auditory stimulus; sleep; memory

Outcome Measures

Primary Outcomes (3)

• Change in EEG waveform amplitude

  Does the acoustic sound delivery alter EEG waveform amplitude of slow wave sleep

  5 seconds after stimulus

• Change in Serial Reaction Time Task memory test

  Does the delivery of acoustic sounds alter post-sleep preformance on the above task

  Baseline and following day

• Change in Paired Associates Learning memory test

  Does the delivery of acoustic sounds alter post-sleep preformance on the above task

  Baseline and following day

Study Arms (2)

Stim First

ACTIVE COMPARATOR

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.

Device: Closed loop auditory stimulus

Sham First

SHAM COMPARATOR

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.

Device: Closed loop auditory stimulus

Interventions

Closed loop auditory stimulus DEVICE

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

Sham First; Stim First

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

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

Cardiff, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Officials

• Khalid Hamandi, MRCP/Phd

  University Hospital of Wales/Cardiff University

  PRINCIPAL INVESTIGATOR

• Jennifer Roebber, PhD

  University Hospital of Wales/Cardiff University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: auditory stimulus was played at 0 or 50 decibels during sleep
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Within subject comparison of stimulus and sham sessions

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 16, 2021
• Study Start: October 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Behavior tasks are available on Gitlab as a repository and can be shared on request

Locations

GB (1)