Closed Loop Auditory Stimulus in Sleep and epilepsY (CLASSY)

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

Study Overview

• Status: Completed
• Conditions: Temporal Lobe Epilepsy
• Intervention / Treatment: Device: Closed loop auditory stimulus

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • Cardiff and Vale UHW, Neurology department, ward C4, video-EEG monitoring unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Closed loop auditory stimulus; 50ms of low volume pink noise delivered during slow wave sleep
Sham Comparator: 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.	Device: Closed loop auditory stimulus; 50ms of low volume pink noise delivered during slow wave sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board
• Investigators: Principal Investigator: Khalid Hamandi, MRCP/Phd, University Hospital of Wales/Cardiff University; Principal Investigator: Jennifer Roebber, PhD, University Hospital of Wales/Cardiff University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: memory; sleep; Closed loop auditory stimulus
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsies, Partial; Epilepsy; Epilepsy, Temporal Lobe
• Other Study ID Numbers: 7796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymous sleeping-EEG and behavior scores can be shared with researchers.
• IPD Sharing Time Frame: Behavior tasks are available on Gitlab as a repository and can be shared on request
• IPD Sharing Supporting Information Type: Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No