Non-restorative SleepNCT07090135
Power Nap With TES-TI
A study testing Transcranial electrical stimulation with Temporal Interference (TES-TI) in people with Non-restorative Sleep and Healthy Volunteer, 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 mental fatigue. Participants will attend 2 study visits, each of which may last up to 4-5 hours. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-restorative Sleep, Healthy Volunteer
- 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
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2025to 28 Sep 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 of any gender identity
- Self-reported non-restorative sleep, as measured by a REST-Q score
- English-speaking (able to provide consent and complete questionnaires)
- Capable of taking daytime naps
- US Citizen
Who cannot join
- Any current or history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
- History of inpatient psychiatric hospitalization
- History of head trauma resulting in prolonged loss of consciousness; or a history of >3 grade I 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, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy except for a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
Show all 17Show fewer
- Possible pregnancy or plan to become pregnant in the next 6 months
- Any metal in the head
- Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator)
- Dental implants
- Permanent retainers
- Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the study sessions
- Any head coverings or headdress that participant feels uncomfortable removing for the purposes of study sessions
- Any medication that may alter seizure threshold taken during the study i.e., ADHD stimulants (Adderall, amphetamine); Tricyclic/atypical antidepressants (amitriptyline, doxepine, imipramine, maprotiline, nortriptyline, bupropion); 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.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53705
About this study
Official title: Enhance the Restorative Power of Sleep Through TES-TI Power Naps
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 mental fatigue.
Participants will attend 2 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 project aims to use transcranial electrical stimulation with temporal interference (TES-TI) to enhance the production of sleep slow waves, boosting the restorative power of sleep and mitigating cognitive impairment (mental fatigue) and its underlying cause (brain fatigue).
- Conditions
- Non-restorative Sleep, Healthy Volunteer
- Being tested
- Transcranial electrical stimulation with Temporal Interference (TES-TI)
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 | 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 | 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.
Change in slow waves
Researchers will do a power analysis on high density EEG data for slow wave frequency (3-5Hz) and see if there is increase in this frequency range during/post stimulation.
Measured: Baseline to 1 month
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 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start19 Dec 2025
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-restorative SleepStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Corundum Convergence Institute
- Responsible party
- Sponsor
- Investigators
- Guilio Tononi, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090135
- Sponsor's protocol ID
- 2025-0481
- Other IDs
- A538900, SMPH/PSYCHIATRY/PSYCHIATRY, Protocol Version 6/5/26
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhance the Restorative Power of Sleep Through TES-TI Power Naps
- ClinicalTrials.gov ID
- NCT07090135
- Acronym / sponsor ID
- 2025-0481
- Conditions
- Non-restorative Sleep, Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Corundum Convergence Institute
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 29 Jul 2025 (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 mental fatigue.
Participants will attend 2 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 project aims to use transcranial electrical stimulation with temporal interference (TES-TI) to enhance the production of sleep slow waves, boosting the restorative power of sleep and mitigating cognitive impairment (mental fatigue) and its underlying cause (brain fatigue).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)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)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 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-75 of any gender identity
- Self-reported non-restorative sleep, as measured by a REST-Q score
- English-speaking (able to provide consent and complete questionnaires)
- Capable of taking daytime naps
- US Citizen
Key exclusion criteria (17 listed)
- Any current or history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
- History of inpatient psychiatric hospitalization
- History of head trauma resulting in prolonged loss of consciousness; or a history of >3 grade I concussions
- Current history of poorly controlled headaches including intractable or poorly controlled migraines
- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy except for 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
Change in slow waves
Time frame: Baseline to 1 month
Researchers will do a power analysis on high density EEG data for slow wave frequency (3-5Hz) and see if there is increase in this frequency range during/post stimulation.
Change in sleep quality and mood
Time frame: Baseline to 1 month
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.
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 5 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Non-restorative Sleep
Recruiting
Sleep Promoting Properties of a Botanical Extract in a Population Complaining From Non-Restorative Sleep (NRS)
Non Restorative Sleep, Sleep Disorder (Disorder)
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.
Guilio Tononi, MD, 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 Non-restorative Sleep and Healthy Volunteer, 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 17 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 5 Oct 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?
Change in slow waves (time frame: Baseline to 1 month). 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 5 Oct 2026.