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Completed

NCT Number: NCT05159609

Closed Loop Auditory Stimulus in Sleep and epilepsY

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

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Key information

Conditions

Temporal Lobe Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Epilepsy, Temporal Lobe Epileptic Syndromes Nervous System Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cardiff, CF14 4XW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Closed loop auditory stimulus

Device

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

Primary outcomes

  1. Change in EEG waveform amplitude

    Time frame: 5 seconds after stimulus

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

  2. Change in Serial Reaction Time Task memory test

    Time frame: Baseline and following day

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

  3. Change in Paired Associates Learning memory test

    Time frame: Baseline and following day

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

Sponsors and collaborators

Lead sponsor

Cardiff and Vale University Health Board

Other Gov

Registry information

Acronym: CLASSY

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2021
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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