Wearable Neural Interfacing System for REM Sleep Restoration and Enhancement

Summary

This study evaluates a wearable system (NEUSleeP) that combines overnight EEG recording with transcranial focused ultrasound (tFUS) targeted to deep brain structures involved in REM sleep regulation (e.g., subthalamic nucleus). The primary objective is to assess safety and estimate effects on REM sleep quantity and architecture; secondary objectives include changes in stress-related measures.

Healthy adults aged 18-50, with or without subclinical sleep or stress complaints, will complete two consecutive overnight recordings: Night 1 (baseline, no stimulation) and Night 2 (tFUS, EEG-guided and timed to REM). Participants will complete stress questionnaires. fMRI is conducted using two paradigms: in an imaging-validation subset, pre- and post-stimulation scans are acquired in the same MRI-FUS session; in the two-night cohorts, scans are acquired the morning before and the morning after the FUS night to assess BOLD responses.

Outcomes include REM time, REM percentage, number of REM periods, REM latency, safety/tolerability, and exploratory neuroimaging and self-reported stress measures. Findings will inform the feasibility of a wearable EEG-tFUS approach to modulate REM sleep and stress adaptation.

Conditions

• Sleep Disturbance
• Stress, Psychological
• REM Sleep Measurement

Interventions

DEVICE

NEUSleeP system (FUS-EEG wearable device)

The NEUSleeP system is a wearable FUS-EEG device integrating hydrogel-based EEG and focused ultrasound neuromodulation. The intervention includes: 1. Device testing in 4 healthy volunteers to assess EEG signal and impedance over 4 weeks vs. wet electrodes; 2. STN targeting validation in up to 20 participants using MRI-guided tFUS with NEUSleeP and BrainSonix Pulsar 1002, with fMRI analysis of BOLD activation in stress-related areas (amygdala, insula); 3. REM sleep modulation in 16 healthy participants across two nights, evaluating REM sleep architecture and stress-related fMRI changes following STN stimulation during REM; 4. A similar protocol in 12 individuals with self-reported poor sleep and moderate stress, assessing subjective stress (PSS), sleep dynamics, and connectivity changes post-tFUS.

DEVICE

BrainSonix Pulsar 1002

The BrainSonix Pulsar 1002 is a research-grade focused ultrasound device used to evaluate STN targeting in up to 20 healthy participants. COMSOL 2D acoustic simulations and structural MRI are used to localize the STN. The BrainSonix system is tuned and installed for STN stimulation during fMRI scanning. Pre- and post-stimulation fMRI is conducted to verify BOLD signal changes in the STN and related regions. These responses are compared with those from NEUSleeP stimulation, using identical imaging protocols. Ultrasound parameters are iteratively adjusted to optimize targeting while adhering to FDA diagnostic ultrasound safety limits. A linear mixed model is used to assess stimulation-induced changes.

Sponsors & Collaborators

• University of Texas at Austin

  lead OTHER

Principal Investigators

• Huiliang (Evan) Wang, Ph.D. · The University of Texas at Austin

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-15

Primary Completion

2025-10-03

Completion

2025-10-03

FDA Device

Yes

Countries

• United States

Study Locations