NCT07090135

Brief 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. During these visits, participants will wear a high density electroencephalography (hdEEG) cap and take a nap.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Dec 2025Apr 2027

First Submitted

Initial submission to the registry

July 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

December 19, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

January 15, 2026

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

July 22, 2025

Last Update Submit

January 13, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline to 1 month

Study Arms (2)

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.

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.

Device: Transcranial electrical stimulation with Temporal Interference (TES-TI)

Interventions

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.

No stimulation followed by stimulationStimulation followed by no stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Guilio Tononi, MD, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2025

First Posted

July 29, 2025

Study Start

December 19, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

January 15, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Locations