Closed Loop Auditory Stimulus in Sleep and epilepsY

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

Detailed Description
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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.

Official Title
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Closed Loop Auditory Stimulus in Sleep and epilepsY

Conditions
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Temporal Lobe Epilepsy

Intervention / Treatment
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* Device: Closed loop auditory stimulus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Within subject comparison of stimulus and sham sessions
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stim First<br>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<br>* 50ms of low volume pink noise delivered during slow wave sleep<br>|
| Sham Comparator: Sham First<br>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<br>* 50ms of low volume pink noise delivered during slow wave sleep<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closed loop auditory stimulus, sleep, memory