CLASSY: Closed Loop Auditory Stimulus in Sleep and epilepsY

Sponsor

Cardiff and Vale University Health Board (Other)

Overall Status

Completed

CT.gov ID

NCT05159609

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Temporal Lobe Epilepsy	Device: Closed loop auditory stimulus	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Within subject comparison of stimulus and sham sessionsWithin subject comparison of stimulus and sham sessions

Masking:

Single (Participant)

Masking Description:

auditory stimulus was played at 0 or 50 decibels during sleep

Primary Purpose:

Basic Science

Official Title:

Closed Loop Auditory Stimulus in Sleep and epilepsY

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiff and Vale UHW, Neurology department, ward C4, video-EEG monitoring unit	Cardiff		United Kingdom	CF14 4XW

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cardiff and Vale University Health Board

ClinicalTrials.gov Identifier:

NCT05159609

Other Study ID Numbers:

7796

First Posted:

Dec 16, 2021

Last Update Posted:

Dec 16, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cardiff and Vale University Health Board

Closed loop auditory stimulus

sleep

memory

Additional relevant MeSH terms:

Epilepsy

Epilepsy, Temporal Lobe

Study Results

No Results Posted as of Dec 16, 2021