Closed Loop Auditory Stimulus in Sleep and epilepsY (CLASSY)

Cardiff and Vale University Health Board

Status: Completed

Conditions: Temporal Lobe Epilepsy

Treatments: Device: Closed loop auditory stimulus

Study type: Interventional

Funder types: Other

Identifiers

NCT05159609

7796

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Stim First

Active Comparator group

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.

Treatment:

Device: Closed loop auditory stimulus

Sham First

Sham Comparator group

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.

Treatment:

Device: Closed loop auditory stimulus