Closed Loop Auditory Stimulus in Sleep and epilepsY (CLASSY)
Primary Purpose
Temporal Lobe Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Closed loop auditory stimulus
Sponsored by
About this trial
This is an interventional basic science trial for Temporal Lobe Epilepsy focused on measuring Closed loop auditory stimulus, sleep, memory
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.
Sites / Locations
- Cardiff and Vale UHW, Neurology department, ward C4, video-EEG monitoring unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Stim First
Sham First
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in EEG waveform amplitude
Does the acoustic sound delivery alter EEG waveform amplitude of slow wave sleep
Change in Serial Reaction Time Task memory test
Does the delivery of acoustic sounds alter post-sleep preformance on the above task
Change in Paired Associates Learning memory test
Does the delivery of acoustic sounds alter post-sleep preformance on the above task
Secondary Outcome Measures
Full Information
NCT ID
NCT05159609
First Posted
November 25, 2021
Last Updated
December 10, 2021
Sponsor
Cardiff and Vale University Health Board
1. Study Identification
Unique Protocol Identification Number
NCT05159609
Brief Title
Closed Loop Auditory Stimulus in Sleep and epilepsY
Acronym
CLASSY
Official Title
Closed Loop Auditory Stimulus in Sleep and epilepsY
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiff and Vale University Health Board
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporal Lobe Epilepsy
Keywords
Closed loop auditory stimulus, sleep, memory
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Within subject comparison of stimulus and sham sessions
Masking
Participant
Masking Description
auditory stimulus was played at 0 or 50 decibels during sleep
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stim First
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham First
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Closed loop auditory stimulus
Intervention Description
50ms of low volume pink noise delivered during slow wave sleep
Primary Outcome Measure Information:
Title
Change in EEG waveform amplitude
Description
Does the acoustic sound delivery alter EEG waveform amplitude of slow wave sleep
Time Frame
5 seconds after stimulus
Title
Change in Serial Reaction Time Task memory test
Description
Does the delivery of acoustic sounds alter post-sleep preformance on the above task
Time Frame
Baseline and following day
Title
Change in Paired Associates Learning memory test
Description
Does the delivery of acoustic sounds alter post-sleep preformance on the above task
Time Frame
Baseline and following day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Hamandi, MRCP/Phd
Organizational Affiliation
University Hospital of Wales/Cardiff University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Roebber, PhD
Organizational Affiliation
University Hospital of Wales/Cardiff University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiff and Vale UHW, Neurology department, ward C4, video-EEG monitoring unit
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Closed Loop Auditory Stimulus in Sleep and epilepsY
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