Closed Loop Auditory Stimulus in Sleep and epilepsY

Not Applicable

Completed

• Conditions: Temporal Lobe Epilepsy
• Interventions: Device: Closed loop auditory stimulus

• Registration Number: NCT05159609
• Lead Sponsor: Cardiff and Vale University Health Board

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.

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Study First Submitted: 2021-11-25
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-10
• Last Update Submitted: 2021-12-10
• Study First Posted: 2021-12-16
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Stim First	Closed loop auditory stimulus	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.
Sham First	Closed loop auditory stimulus	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.

Primary Outcome Measures

Name	Time	Method
Change in Serial Reaction Time Task memory test	Baseline and following day	Does the delivery of acoustic sounds alter post-sleep preformance on the above task
Change in EEG waveform amplitude	5 seconds after stimulus	Does the acoustic sound delivery alter EEG waveform amplitude of slow wave sleep
Change in Paired Associates Learning memory test	Baseline and following day	Does the delivery of acoustic sounds alter post-sleep preformance on the above task

Trial Locations

Locations (1)

Cardiff and Vale UHW, Neurology department, ward C4, video-EEG monitoring unit; 🇬🇧 Cardiff, United Kingdom