NEUSleeP System for REM Sleep Enhancement

(NEUSleeP Trial)

Overseen By Kevin Tang

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must not be taking: Ketamine, Esketamine

Disqualifiers: Psychopathology, Epilepsy, Sleep disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wearable device, the NEUSleeP system, designed to improve REM sleep by using focused ultrasound to target specific brain areas. The main goal is to assess the device's safety and its effects on REM sleep and stress levels. Healthy adults, including those with mild sleep or stress issues, are ideal candidates for this trial. Participants will spend two nights in the study, with the device used on the second night. The results will help determine if this approach can enhance sleep and manage stress. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on sleep improvement and stress management.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current psychiatric medications, as long as they have been on a stable dosage and regimen for at least 3 months. Other treatments like therapy or experimental treatments should not be ongoing during the trial.

What prior data suggests that the NEUSleeP system is safe for enhancing REM sleep?

Studies have shown that the NEUSleeP system, which uses a wearable device to improve REM sleep through focused ultrasound, is generally safe and well-tolerated. Research indicates that this system is lightweight and easy to use, making it suitable for everyday use.

The NEUSleeP system has been tested for its effects on REM sleep patterns and stress levels. Initial findings suggest it may be effective without causing significant side effects. So far, studies involving this technology have reported no major negative effects, which is a positive sign for its safety in humans.

The study is labeled as "Not Applicable" for clinical trial phases, indicating that the safety information likely comes from early research rather than large-scale trials. However, the absence of major safety concerns so far is promising for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NEUSleeP system because it offers a novel way to enhance REM sleep, which is crucial for stress relief and overall mental health. Unlike traditional sleep aids that often involve medication, NEUSleeP employs non-invasive brain stimulation technology to precisely target the subthalamic nucleus (STN), potentially improving sleep quality and reducing stress without pharmaceutical intervention. This method could not only provide a drug-free alternative but also offer quicker, more targeted results by directly modulating brain activity during REM sleep.

What evidence suggests that the NEUSleeP system is effective for enhancing REM sleep?

Research has shown that the NEUSleeP system may improve REM sleep. In this trial, participants will divide into different groups to evaluate the system's effectiveness. The NEUSleeP system, a wearable device, uses gentle sound waves to target brain areas involved in REM sleep, potentially increasing both the time spent in this stage and the overall percentage of REM sleep. It may also help users enter REM sleep more quickly. The system is designed to be safe and comfortable, offering a non-invasive way to enhance sleep quality and manage stress. ^{2 3 5 6 7}

Who Is on the Research Team?

Huiliang (Evan) Wang, Ph.D.

Principal Investigator

The University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-50 who may or may not have minor sleep or stress issues. Participants will undergo two overnight sessions, with the second night involving a wearable device that aims to influence REM sleep. They must be willing to complete questionnaires and some will have fMRI scans before and after the stimulation.

Inclusion Criteria

\- 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Functionality

NEUSleeP device validation through biweekly EEG and impedance testing over 4 weeks

4 weeks

Biweekly visits

STN Stimulation and Imaging Validation

STN targeting validation using structural MRI and fMRI to assess BOLD response in the STN

1 session

1 visit (in-person)

REM Modulation in Healthy Volunteers

Two consecutive overnight recordings: Night 1 baseline (no stimulation) and Night 2 tFUS

2 nights

2 overnight visits

REM Modulation in Participants with Non-clinical Sleep Disturbance

Two-night protocol with baseline overnight EEG/EMG/EOG recording followed by NEUSleeP-guided FUS stimulation

2 nights

2 overnight visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NEUSleeP system

Trial Overview The NEUSleeP system, which records brain activity during sleep and uses ultrasound waves aimed at specific brain areas to potentially enhance REM sleep, is being tested. The study looks at how safe it is and its effect on REM sleep patterns as well as stress levels.

How Is the Trial Designed?

Group I: Subclinical Sleep Disturbance Group - NEUSleeP REM Modulation Experimental Treatment 1 Intervention

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.

Group II: Healthy Volunteers - NEUSleeP Validation and Modulation Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07190287

Wearable Neural Interfacing System for REM Sleep ... This study evaluates the safety, feasibility, and preliminary signals of effect of NEUSleeP, a wearable neural interface for closed-loop modulation of REM sleep ...

2. withpower.com withpower.com/trial/phase-parasomnias-6-2025-3e3d4

NEUSleeP System for REM Sleep Enhancement Outcomes include REM time, REM percentage, number of REM periods, REM latency, safety/tolerability, and exploratory neuroimaging and self-reported stress ...

3. biorxiv.org biorxiv.org/content/10.1101/2025.10.19.683337v1.full-text

Wearable Focused Ultrasound Neuromodulation and ... In conclusion, NEUSLeeP demonstrates that wearable ultrasound neuromodulation during natural sleep is feasible and can enhance REM-related ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12089259/

The Latest Advances in Non-Invasive Neurostimulation for ... After 20 treatments, the sleep latency and rapid eye movement (REM) latency gradually shortened, and the total sleep time and sleep efficiency ...

5. biorxiv.org biorxiv.org/content/10.1101/2025.10.19.683337v2.full.pdf

Wearable Focused Ultrasound Neuromodulation and ... sleep is feasible and can enhance REM-related outcomes while eliciting spatially selective neural. 481 effects consistent with localized ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07190287

Wearable Neural Interfacing System for REM Sleep ... This study evaluates the safety, feasibility, and preliminary signals of effect of NEUSleeP, a wearable neural interface for closed-loop modulation of REM sleep ...

7. meddatax.com meddatax.com/clinical-trials/NCT07190287

Wearable Neural Interfacing System for REM Sleep Restoration and ... This study evaluates a wearable system (NEUSleeP) that combines overnight EEG recording with transcranial focused ultrasound (tFUS) targeted to deep brain ...