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| ID | Type | Description | Link |
|---|---|---|---|
| HR00112490326 | Other Grant/Funding Number | Department of Defense | |
| A538900 | Other Identifier | UW Madison | |
| SMPH/PSYCHIATRY/PSYCHIATRY | Other Identifier | UW Madison | |
| Protocol Version 6/12/2025 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giulio Tononi, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53719 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 7, 2025 | Feb 17, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| 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 |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |