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Clinical Trials/NCT05159609
NCT05159609
Completed
N/A

Closed Loop Auditory Stimulus in Sleep and epilepsY

Cardiff and Vale University Health Board1 site in 1 country17 target enrollmentOctober 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Temporal Lobe Epilepsy
Sponsor
Cardiff and Vale University Health Board
Enrollment
17
Locations
1
Primary Endpoint
Change in Serial Reaction Time Task memory test
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
August 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Change in EEG waveform amplitude

Time Frame: 5 seconds after stimulus

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

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

Study Sites (1)

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