Closed Loop Auditory Stimulus in Sleep and epilepsY

Temporal Lobe Epilepsy Clinical Trial

— CLASSY  

Official title:

Closed Loop Auditory Stimulus in Sleep and epilepsY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05159609
• Other study ID #: 7796
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: December 2021
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe
• Temporal Lobe Epilepsy

Intervention

Device:
• Closed loop auditory stimulus
50ms of low volume pink noise delivered during slow wave sleep

Locations

Country	Name	City	State
United Kingdom	Cardiff and Vale UHW, Neurology department, ward C4, video-EEG monitoring unit	Cardiff

Sponsors (1)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in EEG waveform amplitude	Does the acoustic sound delivery alter EEG waveform amplitude of slow wave sleep	5 seconds after stimulus
Primary	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
Primary	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