Healthy VolunteersREM-RESTNCT06547086
Rapid Eye Movement Restoration and Enhancement for Sleep-deprived Trauma-adaptation
A study testing Transcranial electrical stimulation with Temporal Interference (TES-TI) in people with Healthy Volunteers, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this clinical trial is to find out whether stimulating the brain with electrical current during naps can increase certain kinds of brain activity that happen during sleep and lead to improvements in emotional health and stress resilience. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Transcranial electrical stimulation with Temporal Interference (TES-TI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2024to 6 Feb 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-50 years
- Medically healthy
- English-speaking (able to provide consent and complete questionnaires)
- Citizen or holding permanent resident status
- Regular napper (1 or more naps per week)
Who cannot join
- Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
- History or head trauma resulting in prolonged loss of consciousness; or a history of >3 grade 1 concussions
- Current history of poorly controlled headaches including intractable or poorly controlled migraines
- Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc)
- History of seizures, diagnosis of epilepsy, histoy of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
- Possible pregnancy or plan to become pregnant in the next 6 months
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- Any metal in the body
- Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
- Dental implants containing metal
- Any medication that may alter seizure threshold: ADHD stimulants (Adderall, amphetamine); tricyclic/stypical antidepressants (amitriptyline, doxepine, imipramine, maprotiline, nortriptyline, buproprion); antipsychotics (chlorpromazine, clozapine); bronchodilators (theophylline, aminophylline); antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antivirals (valacyclovir, ritonavir); OTC antihistamines (diphenhydramine, Benadryl)
- Claustrophobia (a fear of small or closed places)
- Back problems that would prevent lying flat for up to two hours
- Regular night-shift work (second or third shift)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to find out whether stimulating the brain with electrical current during naps can increase certain kinds of brain activity that happen during sleep and lead to improvements in emotional health and stress resilience.
Participants will attend up to 3 study visits, each of which may last up to 4-5 hours. During these visits, participants will wear a high density electroencephalography (hdEEG) cap and take a nap.
Read the detailed description
This is a single-blind, two-phase study. In the first phase, each participant will be assigned a nap length, a trigger region, a stimulation type (difference frequency, multipolar transcranial electrical stimulation with temporal interference (TES-TI), or phase modulation), and a stimulation start time relative to the appearance of spindles and sawtooth waves in their EEG. These parameters will be varied across and within participants who may undergo multiple naps in order to identify optimal parameters for enhancing REM sleep.
Phase II is a single-blind study comprised of 40 participants. Each participant will undergo two 90-minute naps with possible sham or non-sham stimulation conditions. The naps will be on 2 separate visits to the lab with at least 1 week between visits. Conditions on each visit are randomized and counterbalanced. During each visit, participants will complete both the REST-Q and SSS questionnaires. Full HDEEG will be applied as well as 4-16 stimulation electrodes. Participants will then undergo an emotion regulation task (face task) wherein they are presented with positive, negative, or neutral emotional stimuli. This is followed by a resting EEG recording, then a nap up to 90 minutes in duration. Either sham or non-sham stimuli will be applied at times during the nap period. Upon waking, the same questionnaires and emotion regulation tasks will be completed.
- Conditions
- Healthy Volunteers
- Being tested
- Transcranial electrical stimulation with Temporal Interference (TES-TI)
- Keywords
- Regular nap taker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial electrical stimulation with Temporal Interference (TES-TI)Device
TES-TI uses specific electrode arrangement patterns to selectively stimulate the brain. Participants will wear an hdEEG (high density electroencephalography) cap which will allow intermittent periods of stimulation from TES-TI.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation followed by no stimulation | Experimental | Phase 2 participants will receive stimulation during their nap at the first visit, and no stimulation during their nap at the second visit. Receives: Device: Transcranial electrical stimulation with Temporal Interference (TES-TI) |
| No stimulation followed by stimulation | Experimental | Phase 2 participants will not receive stimulation during their nap at the first visit, and receive stimulation during their nap at the second visit. Receives: Device: Transcranial electrical stimulation with Temporal Interference (TES-TI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify effective TES-TI parameters to trigger spindles
Researchers will do a power analysis on high density EEG data for spindle frequency (11-15Hz) and see if there is increase in this frequency range during/post stimulation.
Measured: Post nap (up to 90 minutes)
Identify effective TES-TI parameters to trigger spindles
Researchers will do a power analysis on high density EEG data for sawtooth wave frequency (3-5Hz) and see if there is increase in this frequency range during/post stimulation.
Measured: Post nap (up to 90 minutes)
Identify effective duration of the nap to maximize TES-TI effect on REM sleep
Researchers will compare the durations of nap (sleep duration on the EEG) within subjects across their multiple visits, as well as across subjects; correlating this with the stimulation parameters
Measured: Post nap (up to 90 minutes)
Change in spindles after effective TES-TI intervention
Changes in sleep spindle density during sleep as measured by portable EEG device.
Measured: Post nap (up to 90 minutes)
Change in sawtooth waves after effective TES-TI intervention
Researchers will do a power analysis on high density EEG data for sawtooth wave frequency (3-5Hz) and see if there is increase in this frequency range during/post stimulation.
Measured: Post nap (up to 90 minutes)
Change in score for vigilance task
The vigilance task is a computerized reaction time task where participants are presented with a fixation point on a computer screen. At random, the fixation point will change appearance at which point the participant is to click a provided button as quickly as possible. The latency response is recorded automatically. Faster responses are indicative of higher vigilance.
Measured: Baseline to post-nap (up to 90 minutes)
Change in sleep quality and mood
Sleep quality and mood will be assessed using the Restorative Sleep Questionnaire (REST-Q), a 9-item questionnaire assessing aspects of restorative sleep. Each item is scored on a 5-point Likert scale, scores range from 9-45. A higher score indicates a more restorative sleep
Measured: Baseline to post-nap (up to 90 minutes)
Change in sleepiness
Sleepiness will be measured using the Stanford Sleepiness Scale (SSS). SSS is a measure of subjective alertness on a 7-point scale. A lower score on the scale indicated higher alertness.
Measured: Baseline to post-nap (up to 90 minutes)
Change in emotion response
Emotional response is measured using an emotional processing task. This task involves viewing a series of emotionally charged images (60 positive, 60 negative, 60 neutral). Participants see a randomized set of these images and are asked to evaluate how pleasant and emotionally arousing each image is on respective 9-point Likert scales
Measured: Baseline to post-nap (up to 90 minutes)
Change in Spectral Power in Sawtooth Wave Frequency (3-5Hz)
Measured: Baseline to 4 weeks
Change in minutes scored as REM sleep
EEG data will be recorded during sleep. The sleep EEG data is separated into stages (REM-NREM). This way, it is known how many minutes they spend in each stage.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start10 Jul 2024
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Giulio Tononi, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547086
- Sponsor's protocol ID
- 2024-0352
- Other IDs
- HR00112490326, A538900, SMPH/PSYCHIATRY/PSYCHIATRY, Protocol Version 6/12/2025
- Acronym
- REM-REST
- Status last verified
- Feb 2026
- First submitted
- 1 Aug 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Eye Movement Restoration and Enhancement for Sleep-deprived Trauma-adaptation
- ClinicalTrials.gov ID
- NCT06547086
- Acronym / sponsor ID
- REM-REST / 2024-0352
- Conditions
- Healthy Volunteers
- Keywords
- Regular nap taker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 9 Aug 2024 (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.
The goal of this clinical trial is to find out whether stimulating the brain with electrical current during naps can increase certain kinds of brain activity that happen during sleep and lead to improvements in emotional health and stress resilience.
Participants will attend up to 3 study visits, each of which may last up to 4-5 hours. During these visits, participants will wear a high density electroencephalography (hdEEG) cap and take a nap.
Detailed description
This is a single-blind, two-phase study. In the first phase, each participant will be assigned a nap length, a trigger region, a stimulation type (difference frequency, multipolar transcranial electrical stimulation with temporal interference (TES-TI), or phase modulation), and a stimulation start time relative to the appearance of spindles and sawtooth waves in their EEG. These parameters will be varied across and within participants who may undergo multiple naps in order to identify optimal parameters for enhancing REM sleep.
Phase II is a single-blind study comprised of 40 participants. Each participant will undergo two 90-minute naps with possible sham or non-sham stimulation conditions. The naps will be on 2 separate visits to the lab with at least 1 week between visits. Conditions on each visit are randomized and counterbalanced. During each visit, participants will complete both the REST-Q and SSS questionnaires. Full HDEEG will be applied as well as 4-16 stimulation electrodes. Participants will then undergo an emotion regulation task (face task) wherein they are presented with positive, negative, or neutral emotional stimuli. This is followed by a resting EEG recording, then a nap up to 90 minutes in duration. Either sham or non-sham stimuli will be applied at times during the nap period. Upon waking, the same questionnaires and emotion regulation tasks will be completed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation followed by no stimulation | Experimental | Device: Transcranial electrical stimulation with Temporal Interference (TES-TI)Phase 2 participants will receive stimulation during their nap at the first visit, and no stimulation during their nap at the second visit. |
| No stimulation followed by stimulation | Experimental | Device: Transcranial electrical stimulation with Temporal Interference (TES-TI)Phase 2 participants will not receive stimulation during their nap at the first visit, and receive stimulation during their nap at the second visit. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18-50 years
- Medically healthy
- English-speaking (able to provide consent and complete questionnaires)
- Citizen or holding permanent resident status
- Regular napper (1 or more naps per week)
Key exclusion criteria (13 listed)
- Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
- History or head trauma resulting in prolonged loss of consciousness; or a history of >3 grade 1 concussions
- Current history of poorly controlled headaches including intractable or poorly controlled migraines
- Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc)
- History of seizures, diagnosis of epilepsy, histoy of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
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 stimulation with Temporal Interference (TES-TI)TES-TI uses specific electrode arrangement patterns to selectively stimulate the brain. Participants will wear an hdEEG (high density electroencephalography) cap which will allow intermittent periods of stimulation from TES-TI. | Device | No stimulation followed by stimulation, Stimulation followed by no stimulation |
Primary outcome
Identify effective TES-TI parameters to trigger spindles
Time frame: Post nap (up to 90 minutes)
Researchers will do a power analysis on high density EEG data for spindle frequency (11-15Hz) and see if there is increase in this frequency range during/post stimulation.
Identify effective TES-TI parameters to trigger spindles
Time frame: Post nap (up to 90 minutes)
Researchers will do a power analysis on high density EEG data for sawtooth wave frequency (3-5Hz) and see if there is increase in this frequency range during/post stimulation.
Identify effective duration of the nap to maximize TES-TI effect on REM sleep
Time frame: Post nap (up to 90 minutes)
Researchers will compare the durations of nap (sleep duration on the EEG) within subjects across their multiple visits, as well as across subjects; correlating this with the stimulation parameters
Change in spindles after effective TES-TI intervention
Time frame: Post nap (up to 90 minutes)
Changes in sleep spindle density during sleep as measured by portable EEG device.
Change in sawtooth waves after effective TES-TI intervention
Time frame: Post nap (up to 90 minutes)
Researchers will do a power analysis on high density EEG data for sawtooth wave frequency (3-5Hz) and see if there is increase in this frequency range during/post stimulation.
Change in score for vigilance task
Time frame: Baseline to post-nap (up to 90 minutes)
The vigilance task is a computerized reaction time task where participants are presented with a fixation point on a computer screen. At random, the fixation point will change appearance at which point the participant is to click a provided button as quickly as possible. The latency response is recorded automatically. Faster responses are indicative of higher vigilance.
Change in sleep quality and mood
Time frame: Baseline to post-nap (up to 90 minutes)
Sleep quality and mood will be assessed using the Restorative Sleep Questionnaire (REST-Q), a 9-item questionnaire assessing aspects of restorative sleep. Each item is scored on a 5-point Likert scale, scores range from 9-45. A higher score indicates a more restorative sleep
Change in sleepiness
Time frame: Baseline to post-nap (up to 90 minutes)
Sleepiness will be measured using the Stanford Sleepiness Scale (SSS). SSS is a measure of subjective alertness on a 7-point scale. A lower score on the scale indicated higher alertness.
Change in emotion response
Time frame: Baseline to post-nap (up to 90 minutes)
Emotional response is measured using an emotional processing task. This task involves viewing a series of emotionally charged images (60 positive, 60 negative, 60 neutral). Participants see a randomized set of these images and are asked to evaluate how pleasant and emotionally arousing each image is on respective 9-point Likert scales
Change in Spectral Power in Sawtooth Wave Frequency (3-5Hz)
Time frame: Baseline to 4 weeks
Change in minutes scored as REM sleep
Time frame: Baseline to 4 weeks
EEG data will be recorded during sleep. The sleep EEG data is separated into stages (REM-NREM). This way, it is known how many minutes they spend in each stage.
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 19 Feb 2026.
- 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.
Giulio Tononi, PhD principal investigator
University of Wisconsin, Madison
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 stimulation with Temporal Interference (TES-TI) in people with Healthy Volunteers, run by University of Wisconsin, Madison 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 5 inclusion and 13 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 19 Feb 2026. 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?
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?
Identify effective TES-TI parameters to trigger spindles (time frame: Post nap (up to 90 minutes)). The study lists 11 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 19 Feb 2026.