NCT06547086

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-07-10
• Primary completion: 2026-02-06
• Completion: 2026-02-06
• First posted: 2024-08-09
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study