Sleep DisturbanceNCT03751982
Closed Loop TES for Enhancing Slow Wave Sleep
A study testing Transcranial Electrical Neuromodulation (TES) in people with Sleep Disturbance and Insomnia, run by Brain Electrophysiology Laboratory Company at 1 site in United States.
Trial summary
Compare closed-loop with open-loop application of TES to enhance slow waves of sleep. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Insomnia
- What is being tested?
- Transcranial Electrical Neuromodulation (TES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 14 Jan 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults
Who cannot join
- persons with epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brain Electrophysiology Laboratory Company
Eugene, Oregon, 97405
Don M Tucker, PhD
About this study
Official title: Improving Spatiotemporal Precision in Noninvasive Electrical Neuromodulation
Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.
Read the detailed description
Note: FDA has determined that TES with the stimulus parameters as specified for this trial presents no significant risk, so that FDA clearance is not required.
Several findings suggest that Transcranial Electrical Stimulation (TES) may be particularly effective if it is aligned with ongoing brain activity. One condition of the present research is an open-loop design, in which TES pulses (0.75 Hz pulses; 2.0 mA) are presented during slow wave sleep. The other condition is a closed-loop design, using identical pulses, but these will be phase aligned with the slow waves of sleep, measured by the electroencephalogram (EEG). The hypothesis is that closed-loop TES will be more effective in enhancing the amplitude and duration of slow wave sleep than open-loop TES.
- Conditions
- Sleep Disturbance, Insomnia
- Being tested
- Transcranial Electrical Neuromodulation (TES)
- Keywords
- transcranial electrical stimulation
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Electrical Neuromodulation (TES)Device
TES phase-aligned with slow waves or not
| Study group | Role | What they receive |
|---|---|---|
| Open-Loop | Active comparator | In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is not synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz. Receives: Device: Transcranial Electrical Neuromodulation (TES) |
| Closed-Loop | Experimental | In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz. Receives: Device: Transcranial Electrical Neuromodulation (TES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slow wave amplitude
Amplitude of slow waves of sleep
Measured: Slow Wave Amplitude will be assessed during the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be slow wave amplitude expressed per minute of stage N3 sleep for the study night.
Slow wave duration
Duration of slow wave period in sleep
Measured: Slow Wave Duration will be assessed in minutes for the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be the duration (in minutes) of slow wave stage N3 sleep for the study night.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start14 Jan 2020 (estimated)
- Primary completion14 Jan 2021 (estimated)
- Study completion14 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies 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
- Single group
- Model description
- Within subjects comparison of two effective treatments. Order of treatment is randomized and counterbalanced.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brain Electrophysiology Laboratory Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Don M. Tucker, Brain Electrophysiology Laboratory Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751982
- Sponsor's protocol ID
- 1R44MH115955
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Spatiotemporal Precision in Noninvasive Electrical Neuromodulation
- ClinicalTrials.gov ID
- NCT03751982
- Acronym / sponsor ID
- 1R44MH115955
- Conditions
- Sleep Disturbance, Insomnia
- Keywords
- transcranial electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brain Electrophysiology Laboratory CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (estimated)
- Primary completion
- 14 Jan 2021 (estimated)
- Study completion
- 14 Jan 2022 (estimated)
- First posted
- 23 Nov 2018 (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.
Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.
Detailed description
Note: FDA has determined that TES with the stimulus parameters as specified for this trial presents no significant risk, so that FDA clearance is not required.
Several findings suggest that Transcranial Electrical Stimulation (TES) may be particularly effective if it is aligned with ongoing brain activity. One condition of the present research is an open-loop design, in which TES pulses (0.75 Hz pulses; 2.0 mA) are presented during slow wave sleep. The other condition is a closed-loop design, using identical pulses, but these will be phase aligned with the slow waves of sleep, measured by the electroencephalogram (EEG). The hypothesis is that closed-loop TES will be more effective in enhancing the amplitude and duration of slow wave sleep than open-loop TES.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Within subjects comparison of two effective treatments. Order of treatment is randomized and counterbalanced.
| Arm | Type | Receives |
|---|---|---|
| Open-Loop | Active comparator | Device: Transcranial Electrical Neuromodulation (TES)In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is not synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz. |
| Closed-Loop | Experimental | Device: Transcranial Electrical Neuromodulation (TES)In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults
Key exclusion criteria (1 listed)
- persons with epilepsy
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 |
|---|---|---|
| Transcranial Electrical Neuromodulation (TES)TES phase-aligned with slow waves or not | Device | Closed-Loop, Open-Loop |
Primary outcome
Slow wave amplitude
Time frame: Slow Wave Amplitude will be assessed during the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be slow wave amplitude expressed per minute of stage N3 sleep for the study night.
Amplitude of slow waves of sleep
Slow wave duration
Time frame: Slow Wave Duration will be assessed in minutes for the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be the duration (in minutes) of slow wave stage N3 sleep for the study night.
Duration of slow wave period in sleep
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Electrical Neuromodulation (TES) in people with Sleep Disturbance and Insomnia, run by Brain Electrophysiology Laboratory Company at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Nov 2018. 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 States. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Don M Tucker, PhD (541-653-8266, don.tucker@belco.tech), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slow wave amplitude (time frame: Slow Wave Amplitude will be assessed during the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be slow wave amplitude expressed per minute of stage N3 sleep for the study night.). The study lists 2 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 23 Nov 2018.