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Closed Loop Auditory Stimulus in Sleep and epilepsY

Closed Loop Auditory Stimulus in Sleep and epilepsY

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05159609
Acronym
CLASSY
Enrollment
17
Registered
2021-12-16
Start date
2020-10-01
Completion date
2021-08-31
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporal Lobe Epilepsy

Keywords

Closed loop auditory stimulus, sleep, memory

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.

Interventions

DEVICEClosed loop auditory stimulus

50ms of low volume pink noise delivered during slow wave sleep

Sponsors

Cardiff and Vale University Health Board
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

auditory stimulus was played at 0 or 50 decibels during sleep

Intervention model description

Within subject comparison of stimulus and sham sessions

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in EEG waveform amplitude5 seconds after stimulusDoes the acoustic sound delivery alter EEG waveform amplitude of slow wave sleep
Change in Serial Reaction Time Task memory testBaseline and following dayDoes the delivery of acoustic sounds alter post-sleep preformance on the above task
Change in Paired Associates Learning memory testBaseline and following dayDoes the delivery of acoustic sounds alter post-sleep preformance on the above task

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026