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Completed

NCT Number: NCT06547086

Rapid Eye Movement Restoration and Enhancement for Sleep-deprived Trauma-adaptation

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53719, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. Change in Spectral Power in Sawtooth Wave Frequency (3-5Hz)

    Time frame: Baseline to 4 weeks

  11. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • United States Department of Defense

Registry information

Acronym: REM-REST

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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