Wearable Neural Interfacing System for REM Sleep Restoration and Enhancement

NCT07190287 | Completed DMC FDA Device

• 2 other identifiers: STUDY00005703HR00112490328
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transcranial Focused Ultrasound (tFUS); Wearable EEG; Sleep Modulation; REM Sleep; Subthalamic Nucleus; Closed-Loop Neuromodulation; Non-invasive Brain Stimulation; Stress Adaptation; Neural Interface

Outcome Measures

Primary Outcomes (3)

• Change in Total REM Sleep Time

  This measure evaluates the difference in total time (minutes) spent in rapid eye movement (REM) sleep between the baseline and stimulation nights, as recorded via EEG during overnight polysomnography. The goal is to assess whether STN-targeted tFUS delivered by NEUSLeeP enhances REM sleep duration.

  Night 1 (Baseline) and Night 2 (FUS); consecutive nights.

• Change in REM Sleep Percentage of Total Sleep Time

  Percentage of total sleep time spent in REM sleep will be compared between the baseline and stimulation nights to determine whether NEUSLeeP tFUS enhances REM architecture.

  Night 1 (Baseline) and Night 2 (FUS); consecutive nights.

• Change in STN BOLD Signal Following Ultrasound Stimulation

  This outcome measures the change in blood-oxygen-level-dependent (BOLD) signal in the subthalamic nucleus (STN) before and after transcranial focused ultrasound (tFUS) stimulation using NEUSleeP and BrainSonix devices. Functional MRI will be used to assess activation in the STN and related regions (e.g., amygdala, insula). The goal is to evaluate device efficacy in modulating STN activity.

  pre-FUS (≤15 minutes before) and post-FUS (≤15 minutes after).

Secondary Outcomes (4)

• Change in Number of REM Sleep Cycles

  Night 1 (Baseline) and Night 2 (FUS); consecutive nights.

• Change in REM Sleep Latency

  Night 1 (Baseline) and Night 2 (FUS); consecutive nights.

• Change in Subjective Stress Levels (PSQ Score)

  Night 2 (FUS): pre (≤24 hours before) and post (≤24 hours after).

• Change in Stress-Related Brain Connectivity and Activation (fMRI)

  Day 2 morning (pre-FUS night) and Day 3 morning (post-FUS night).

Study Arms (2)

Healthy Volunteers - NEUSleeP Validation and Modulation

EXPERIMENTAL

Participants will undergo three phases: (1) NEUSleeP device validation through biweekly EEG and impedance testing over 4 weeks (subset of participants); (2) STN targeting validation using BrainSonix and NEUSleeP with structural MRI and fMRI to assess BOLD response in the STN; and (3) overnight REM sleep modulation with NEUSleeP including EEG/EMG/EOG recordings and pre/post fMRI scans to assess stress-related brain activity and REM sleep outcomes.

Device: NEUSleeP system (FUS-EEG wearable device); Device: BrainSonix Pulsar 1002

Subclinical Sleep Disturbance Group - NEUSleeP REM Modulation

EXPERIMENTAL

Participants with non-clinical sleep and stress disturbances (PSQI 5-10, PSS 16-21) will undergo baseline overnight EEG/EMG/EOG recording followed by a second night of NEUSleeP-guided FUS stimulation targeting the STN. Pre- and post-intervention fMRI scans and stress questionnaires will assess neural and behavioral effects.

Device: NEUSleeP system (FUS-EEG wearable device)

Interventions

NEUSleeP system (FUS-EEG wearable device) 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.

Healthy Volunteers - NEUSleeP Validation and Modulation; Subclinical Sleep Disturbance Group - NEUSleeP REM Modulation

BrainSonix Pulsar 1002 DEVICE

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.

Healthy Volunteers - NEUSleeP Validation and Modulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Adults aged 18-50, willing and able to undergo MRI, EEG, and FUS experiments.
• Adults aged 18-50, willing and able to undergo EEG and FUS experiments.
• Pittsburgh Sleep Quality Index (PSQI) score between 5 and 10.
• Perceived Stress Scale (PSS) score between 16 and 21.

You may not qualify if:

• Current or past history of psychopathology, epilepsy, or other seizure disorders.
• Inability to provide informed consent to undergo EEG recording, FUS stimulation, and MRI.
• Diagnosed sleep disorders (e.g., insomnia, obstructive sleep apnea).
• Contraindications to FUS or MRI, including but not limited to: history of stroke, brain tumors, brain hemorrhages, internal wires, electrodes, pacemakers, implants, irremovable ferromagnetic objects in the head that are unsafe for MRI and/or cause large imaging artifacts, brain surgery, moderate-to-severe head injury, any penetrating head injury, or uncontrolled thyroid disorder.
• Pregnant individuals or those attempting to become pregnant (due to unknown MRI-related risks to fetuses).
• Serious medical illnesses likely to interfere with study participation.
• Current active suicidal or homicidal ideation (or suicide attempt within the past 3 months).
• Current substance use disorder.
• Current or recent (within the past 3 months) psychotic symptoms.
• Currently meeting diagnostic criteria for a manic episode.
• Currently engaged in evidence-based or experimental treatments (e.g., weekly cognitive behavioral therapy, transcranial magnetic stimulation, ketamine/esketamine treatment) other than psychiatric medications that have been on a stable dosage and regimen for at least 3 months (including antidepressants, mood stabilizers, atypical antipsychotics, and sedatives/hypnotics), in order to avoid confounding therapeutic effects.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

UT Austin, Biomedical Engineering Department

Austin, Texas, 78712, United States

Location

Related Publications (3)

• Summers J, Nowicki M. Managing organizational improvement in a resource-challenged environment. Healthc Financ Manage. 2002 Jul;56(7):60-2. No abstract available.

  PMID: 12119832 BACKGROUND

• Cicolin A, Lopiano L, Zibetti M, Torre E, Tavella A, Guastamacchia G, Terreni A, Makrydakis G, Fattori E, Lanotte MM, Bergamasco B, Mutani R. Effects of deep brain stimulation of the subthalamic nucleus on sleep architecture in parkinsonian patients. Sleep Med. 2004 Mar;5(2):207-10. doi: 10.1016/j.sleep.2003.10.010.

  PMID: 15033145 BACKGROUND

• Legon W, Sato TF, Opitz A, Mueller J, Barbour A, Williams A, Tyler WJ. Transcranial focused ultrasound modulates the activity of primary somatosensory cortex in humans. Nat Neurosci. 2014 Feb;17(2):322-9. doi: 10.1038/nn.3620. Epub 2014 Jan 12.

  PMID: 24413698 BACKGROUND

MeSH Terms

Conditions

Parasomnias; Stress, Psychological

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Huiliang (Evan) Wang, Ph.D.

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two cohorts in parallel: (1) Healthy adults and (2) adults with subclinical sleep/stress disturbance. Each participant completes two consecutive overnight visits-Night 1 baseline (no stimulation) and Night 2 tFUS with EEG-guided REM-timed delivery-enabling within-subject comparisons (baseline vs stimulation) in each cohort. An imaging-validation subset of healthy volunteers completes a same-day MRI-FUS session with pre/post fMRI to verify targeting and neural engagement. Operational "phases" (device checks, imaging validation, healthy sleep study, subclinical sleep study) are procedural and do not imply staged allocation.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: September 24, 2025
• Study Start: July 15, 2025
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)