Temporal Lobe EpilepsyCLASSYNCT05159609
Closed Loop Auditory Stimulus in Sleep and epilepsY
A study testing Closed loop auditory stimulus in people with Temporal Lobe Epilepsy, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
This is a single-centre pilot study of a non-invasive auditory stimulation during sleep in participants with temporal lobe epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Temporal Lobe Epilepsy
- What is being tested?
- Closed loop auditory stimulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Travelled across more than 2 time zones in the last 2 months
- Prescribed/taking sleeping tablets other than clobazam
- Cannabis use >4 joints/day.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiff and Vale UHW, Neurology department, ward C4, video-EEG monitoring unit
Cardiff, CF14 4XW
About this study
This is a single-centre pilot study of a non-invasive auditory stimulation during sleep in participants with temporal lobe epilepsy.
Read the 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.
- Conditions
- Temporal Lobe Epilepsy
- Being tested
- Closed loop auditory stimulus
- Keywords
- Closed loop auditory stimulus, sleep, memory
- Medical subject headings
- Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed loop auditory stimulusDevice
50ms of low volume pink noise delivered during slow wave sleep
| Study group | Role | What they receive |
|---|---|---|
| Stim First | Active comparator | 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. Receives: Device: Closed loop auditory stimulus |
| Sham First | Sham comparator | 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. Receives: Device: Closed loop auditory stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EEG waveform amplitude
Does the acoustic sound delivery alter EEG waveform amplitude of slow wave sleep
Measured: 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
Measured: 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
Measured: Baseline and following day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Oct 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporal Lobe EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within subject comparison of stimulus and sham sessions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Khalid Hamandi, MRCP/Phd, Principal investigator, University Hospital of Wales/Cardiff UniversityJennifer Roebber, PhD, Principal investigator, University Hospital of Wales/Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159609
- Sponsor's protocol ID
- 7796
- Acronym
- CLASSY
- Status last verified
- Dec 2021
- First submitted
- 25 Nov 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous sleeping-EEG and behavior scores can be shared with researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Loop Auditory Stimulus in Sleep and epilepsY
- ClinicalTrials.gov ID
- NCT05159609
- Acronym / sponsor ID
- CLASSY / 7796
- Conditions
- Temporal Lobe Epilepsy
- Keywords
- Closed loop auditory stimulus, sleep, memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Within subject comparison of stimulus and sham sessions
| Arm | Type | Receives |
|---|---|---|
| Stim First | Active comparator | Device: Closed loop auditory stimulusParticipants 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. |
| Sham First | Sham comparator | Device: Closed loop auditory stimulusParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed loop auditory stimulus50ms of low volume pink noise delivered during slow wave sleep | Device | Sham First, Stim First |
Primary outcome
Change in EEG waveform amplitude
Time frame: 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
Time frame: 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
Time frame: Baseline and following day
Does the delivery of acoustic sounds alter post-sleep preformance on the above task
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: Yes. Anonymous sleeping-EEG and behavior scores can be shared with researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khalid Hamandi, MRCP/Phd principal investigator
University Hospital of Wales/Cardiff University
Jennifer Roebber, PhD principal investigator
University Hospital of Wales/Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed loop auditory stimulus in people with Temporal Lobe Epilepsy, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EEG waveform amplitude (time frame: 5 seconds after stimulus). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.