Sleep DisturbanceNEUSleePNCT07190287
Wearable Neural Interfacing System for REM Sleep Restoration and Enhancement
A study testing NEUSleeP system (FUS-EEG wearable device) and BrainSonix Pulsar 1002 in people with Sleep Disturbance and Stress, Psychological, run by University of Texas at Austin at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Stress, Psychological, REM Sleep Measurement
- What is being tested?
- NEUSleeP system (FUS-EEG wearable device) and BrainSonix Pulsar 1002
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 3 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-50, willing and able to undergo MRI, EEG, and FUS experiments.
- Inclusion Criteria for Healthy Volunteers with Non-Clinical Sleep Disturbances:
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Austin, Biomedical Engineering Department
Austin, Texas, 78712
About this study
Official title: Evaluation of a Wearable EEG-tFUS System for REM Sleep Modulation in Healthy Adults and Individuals With Subclinical Sleep Disturbances
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.
Read the detailed description
This study evaluates the safety, feasibility, and preliminary signals of effect of NEUSleeP, a wearable neural interface for closed-loop modulation of REM sleep using transcranial focused ultrasound (tFUS) targeted to the subthalamic nucleus (STN). The system integrates a flexible ultrasound transducer with bioadhesive hydrogel EEG electrodes in a patch designed for repeated overnight use. REM sleep is implicated in emotional regulation, memory processes, and stress adaptation. Existing noninvasive approaches have focused largely on NREM modulation; this study examines a REM-focused, target-directed approach to determine whether tFUS delivered during sleep can alter REM architecture and related outcomes.
The study comprises four phases:
Phase 1 (device functionality) enrolls four healthy volunteers for repeated bench and on-body checks (EEG signal quality, contact impedance stability, usability) over four weeks, with comparisons to standard clinical electrodes.
Phase 2 (STN stimulation and imaging validation) uses structural MRI and acoustic modeling to configure STN targeting for both a reference research system (BrainSonix Pulsar 1002) and NEUSleeP. In up to 20 healthy volunteers, functional MRI is acquired immediately before and immediately after the same MRI-FUS session to characterize BOLD responses in STN and stress-related networks (e.g., amygdala, insula), using identical imaging protocols across platforms.
Phase 3 (REM modulation in healthy volunteers) enrolls 16 adults for two consecutive overnight recordings: Night 1 baseline (no stimulation) and Night 2 tFUS (closed-loop stimulation time-locked to REM using EEG). Primary sleep outcomes include REM time, REM percentage, number of REM periods, and REM latency; safety and tolerability are recorded throughout.
Phase 4 (REM modulation in participants with non-clinical sleep disturbance) enrolls 12 adults with elevated sleep complaints and perceived stress for the same two-night protocol; exploratory outcomes include self-reported stress measures collected around the FUS night.
Two fMRI paradigms are used across phases. In Phase 2, a same-session MRI-FUS visit includes pre-stimulation and post-stimulation fMRI acquisitions in the same session (healthy imaging-validation subset). In Phases 3 and 4, participants complete morning-before (pre-FUS night) and morning-after (post-FUS night) fMRI sessions to assess changes around the overnight REM-timed stimulation.
Safety procedures include MRI screening where applicable, continuous adverse event capture, stop rules for stimulation, and post-visit follow-up. Ultrasound exposure is controlled within established diagnostic ultrasound limits (e.g., MI <= 1.9 and derated time-averaged intensity within applicable FDA limits), with device-level acoustic verification prior to use. Data monitoring is performed by the study team with predefined criteria for pausing or discontinuation. Findings will inform the feasibility of a wearable EEG-tFUS approach for REM-related modulation and guide parameters for future controlled trials.
- Being tested
- NEUSleeP system (FUS-EEG wearable device), BrainSonix Pulsar 1002
- Keywords
- Transcranial Focused Ultrasound (tFUS), Wearable EEG, Sleep Modulation, REM Sleep, Subthalamic Nucleus, Closed-Loop Neuromodulation, Non-invasive Brain Stimulation, Stress Adaptation, Neural Interface
- Medical subject headings
- Parasomnias, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- Device testing in 4 healthy volunteers to assess EEG signal and impedance over 4 weeks vs. wet electrodes;
- 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);
- REM sleep modulation in 16 healthy participants across two nights, evaluating REM sleep architecture and stress-related fMRI changes following STN stimulation during REM;
- 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.
BrainSonix Pulsar 1002Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: NEUSleeP system (FUS-EEG wearable device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: pre-FUS (≤15 minutes before) and post-FUS (≤15 minutes after).
Secondary outcomes (4)
Change in Number of REM Sleep Cycles
The number of distinct REM sleep cycles will be recorded on both baseline and stimulation nights to evaluate the effect of STN-targeted tFUS on REM cycling.
Measured: Night 1 (Baseline) and Night 2 (FUS); consecutive nights.
Change in REM Sleep Latency
Time (in minutes) from sleep onset to the first REM episode will be measured and compared between the baseline and stimulation nights to assess whether tFUS shortens REM latency.
Measured: Night 1 (Baseline) and Night 2 (FUS); consecutive nights.
Change in Subjective Stress Levels (PSQ Score)
Participants will complete the Perceived Stress Questionnaire (PSQ) before and after the stimulation night. Changes in PSQ scores will assess the effect of STN-targeted tFUS on perceived stress.
Measured: Night 2 (FUS): pre (≤24 hours before) and post (≤24 hours after).
Change in Stress-Related Brain Connectivity and Activation (fMRI)
Resting-state BOLD fMRI will assess changes in amygdala and insula connectivity before and after the stimulation night. In addition, an fMRI facial emotion recognition task will evaluate activation changes in stress-related neural circuits.
Measured: Day 2 morning (pre-FUS night) and Day 3 morning (post-FUS night).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start15 Jul 2025
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan (Huiliang) Wang, University of Texas at Austin
- Investigators
- Huiliang (Evan) Wang, Ph.D., Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190287
- Sponsor's protocol ID
- STUDY00005703
- Other IDs
- HR00112490328
- Acronym
- NEUSleeP
- Status last verified
- Oct 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tang KWK, Jeong J, Hsieh JC, Yao M, Ding H, Wang W, Liu X, Pyatnitskiy I, He W, Moscoso-Barrera WD, Lozano AR, Artman B, Huh H, Wilson PS, Wang H. Bioadhesive hydrogel-coupled and miniaturized ultrasound transducer system for long-term, wearable neuromodulation. Nat Commun. 2025 May 28;16(1):4940. doi: 10.1038/s41467-025-60181-x.
PubMed 40436843Cicolin 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.
PubMed 15033145Legon 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.
PubMed 24413698Tang KWK, Baird B, Moscoso-Barrera WD, Yu M, Yao M, Jeong J, Pyatnitskiy I, Romero Lozano A, Wang J, Hsieh JC, Chae TS, Song D, Garcia J, Mittapalli R, Bush A, Legon W, Mysliwiec V, Fonzo GA, Wang H. Skin-attached bioadhesive patch enabling ultrasound deep brain stimulation and real-time electrophysiological monitoring for REM sleep enhancement. Nat Commun. 2026 Jun 4;17(1):5570. doi: 10.1038/s41467-026-73787-6.
PubMed 42243115
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Wearable EEG-tFUS System for REM Sleep Modulation in Healthy Adults and Individuals With Subclinical Sleep Disturbances
- ClinicalTrials.gov ID
- NCT07190287
- Acronym / sponsor ID
- NEUSleeP / STUDY00005703
- Keywords
- Transcranial Focused Ultrasound (tFUS), Wearable EEG, Sleep Modulation, REM Sleep, Subthalamic Nucleus, Closed-Loop Neuromodulation, Non-invasive Brain Stimulation, Stress Adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study evaluates the safety, feasibility, and preliminary signals of effect of NEUSleeP, a wearable neural interface for closed-loop modulation of REM sleep using transcranial focused ultrasound (tFUS) targeted to the subthalamic nucleus (STN). The system integrates a flexible ultrasound transducer with bioadhesive hydrogel EEG electrodes in a patch designed for repeated overnight use. REM sleep is implicated in emotional regulation, memory processes, and stress adaptation. Existing noninvasive approaches have focused largely on NREM modulation; this study examines a REM-focused, target-directed approach to determine whether tFUS delivered during sleep can alter REM architecture and related outcomes.
The study comprises four phases:
Phase 1 (device functionality) enrolls four healthy volunteers for repeated bench and on-body checks (EEG signal quality, contact impedance stability, usability) over four weeks, with comparisons to standard clinical electrodes.
Phase 2 (STN stimulation and imaging validation) uses structural MRI and acoustic modeling to configure STN targeting for both a reference research system (BrainSonix Pulsar 1002) and NEUSleeP. In up to 20 healthy volunteers, functional MRI is acquired immediately before and immediately after the same MRI-FUS session to characterize BOLD responses in STN and stress-related networks (e.g., amygdala, insula), using identical imaging protocols across platforms.
Phase 3 (REM modulation in healthy volunteers) enrolls 16 adults for two consecutive overnight recordings: Night 1 baseline (no stimulation) and Night 2 tFUS (closed-loop stimulation time-locked to REM using EEG). Primary sleep outcomes include REM time, REM percentage, number of REM periods, and REM latency; safety and tolerability are recorded throughout.
Phase 4 (REM modulation in participants with non-clinical sleep disturbance) enrolls 12 adults with elevated sleep complaints and perceived stress for the same two-night protocol; exploratory outcomes include self-reported stress measures collected around the FUS night.
Two fMRI paradigms are used across phases. In Phase 2, a same-session MRI-FUS visit includes pre-stimulation and post-stimulation fMRI acquisitions in the same session (healthy imaging-validation subset). In Phases 3 and 4, participants complete morning-before (pre-FUS night) and morning-after (post-FUS night) fMRI sessions to assess changes around the overnight REM-timed stimulation.
Safety procedures include MRI screening where applicable, continuous adverse event capture, stop rules for stimulation, and post-visit follow-up. Ultrasound exposure is controlled within established diagnostic ultrasound limits (e.g., MI <= 1.9 and derated time-averaged intensity within applicable FDA limits), with device-level acoustic verification prior to use. Data monitoring is performed by the study team with predefined criteria for pausing or discontinuation. Findings will inform the feasibility of a wearable EEG-tFUS approach for REM-related modulation and guide parameters for future controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers - NEUSleeP Validation and Modulation | Experimental | Device: NEUSleeP system (FUS-EEG wearable device), Device: BrainSonix Pulsar 1002Participants 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. |
| Subclinical Sleep Disturbance Group - NEUSleeP REM Modulation | Experimental | Device: NEUSleeP system (FUS-EEG wearable device)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Healthy Volunteers - NEUSleeP Validation and Modulation, Subclinical Sleep Disturbance Group - NEUSleeP REM Modulation |
| BrainSonix Pulsar 1002The 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. | Device | Healthy Volunteers - NEUSleeP Validation and Modulation |
Primary outcome
Change in Total REM Sleep Time
Time frame: Night 1 (Baseline) and Night 2 (FUS); consecutive nights.
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.
Change in REM Sleep Percentage of Total Sleep Time
Time frame: Night 1 (Baseline) and Night 2 (FUS); consecutive nights.
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.
Change in STN BOLD Signal Following Ultrasound Stimulation
Time frame: pre-FUS (≤15 minutes before) and post-FUS (≤15 minutes after).
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.
4 secondary outcomes
Change in Number of REM Sleep Cycles
Time frame: Night 1 (Baseline) and Night 2 (FUS); consecutive nights.
Change in REM Sleep Latency
Time frame: Night 1 (Baseline) and Night 2 (FUS); consecutive nights.
Change in Subjective Stress Levels (PSQ Score)
Time frame: Night 2 (FUS): pre (≤24 hours before) and post (≤24 hours after).
Change in Stress-Related Brain Connectivity and Activation (fMRI)
Time frame: Day 2 morning (pre-FUS night) and Day 3 morning (post-FUS night).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Background: PubMed 40436843Tang KWK, Jeong J, Hsieh JC, Yao M, Ding H, Wang W, Liu X, Pyatnitskiy I, He W, Moscoso-Barrera WD, Lozano AR, Artman B, Huh H, Wilson PS, Wang H. Bioadhesive hydrogel-coupled and miniaturized ultrasound transducer system for long-term, wearable neuromodulation. Nat Commun. 2025 May 28;16(1):4940. doi: 10.1038/s41467-025-60181-x.
- Background: PubMed 15033145Cicolin 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.
- Background: PubMed 24413698Legon 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.
- Derived from this study: PubMed 42243115Tang KWK, Baird B, Moscoso-Barrera WD, Yu M, Yao M, Jeong J, Pyatnitskiy I, Romero Lozano A, Wang J, Hsieh JC, Chae TS, Song D, Garcia J, Mittapalli R, Bush A, Legon W, Mysliwiec V, Fonzo GA, Wang H. Skin-attached bioadhesive patch enabling ultrasound deep brain stimulation and real-time electrophysiological monitoring for REM sleep enhancement. Nat Commun. 2026 Jun 4;17(1):5570. doi: 10.1038/s41467-026-73787-6.
- Individual participant dataSharing planned: No
Related trials for Sleep Disturbance
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiliang (Evan) Wang, Ph.D. principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEUSleeP system (FUS-EEG wearable device) and BrainSonix Pulsar 1002 in people with Sleep Disturbance and Stress, Psychological, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total REM Sleep Time (time frame: Night 1 (Baseline) and Night 2 (FUS); consecutive nights.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07190287, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.