CompletedNot Applicable

Wearable Neural Interfacing System for REM Sleep Restoration and Enhancement

United States52 participantsStarted 2025-07-15

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for Healthy Volunteers: \- 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. Exclusion Criteria for Both Groups: * 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 mani…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Total REM Sleep Time

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

Change in REM Sleep Percentage of Total Sleep Time

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

Change in STN BOLD Signal Following Ultrasound Stimulation

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

Trial details

NCT IDNCT07190287

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-03

View on ClinicalTrials.gov More Sleep Disturbance trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Total REM Sleep Time

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

Change in REM Sleep Percentage of Total Sleep Time

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

Change in STN BOLD Signal Following Ultrasound Stimulation

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