Rapid Eye Movement Restoration and Enhancement for Sleep-deprived Trauma-adaptation
REM-REST
5 other identifiers
interventional
72
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy-volunteers
Started Jul 2024
Typical duration for not_applicable healthy-volunteers
1 active site
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 Start
First participant enrolled
July 10, 2024
CompletedFirst Submitted
Initial submission to the registry
August 1, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2026
CompletedFebruary 19, 2026
February 1, 2026
1.6 years
August 1, 2024
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
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.
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.
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
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.
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.
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.
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
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.
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
Baseline to post-nap (up to 90 minutes)
Change in Spectral Power in Sawtooth Wave Frequency (3-5Hz)
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.
Baseline to 4 weeks
Study Arms (2)
Stimulation followed by no stimulation
EXPERIMENTALPhase 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
EXPERIMENTALPhase 2 participants will not receive stimulation during their nap at the first visit, and receive stimulation during their nap at the second visit.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53719, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giulio Tononi, PhD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2024
First Posted
August 9, 2024
Study Start
July 10, 2024
Primary Completion
February 6, 2026
Study Completion
February 6, 2026
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share