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NCT07190287 · ClinicalTrials.gov registry record · NA
Wearable Neural Interfacing System for REM Sleep Restoration and Enhancement
A NA study of Sleep Disturbance and Stress, Psychological, sponsored by University of Texas at Austin.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT07190287 is a NA study of Sleep Disturbance and Stress, Psychological that has completed, run by University of Texas at Austin. The registered enrollment target is 52 participants, below the 177-participant average among 56 other Sleep Disturbance trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07190287, a NA study of Sleep Disturbance and Stress, Psychological, has completed, sponsored by University of Texas at Austin.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE BrainSonix Pulsar 1002
- DEVICE NEUSleeP system (FUS-EEG wearable device)
Study Locations (1)
Texas
- UT Austin, Biomedical Engineering Department - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2025-07-15 |
| Est. Completion | 2025-10-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07190287
The ClinicalTrials.gov registry entry for NCT07190287 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 177-participant average among 56 other Sleep Disturbance trials with a reported enrollment target (71% lower). The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Sleep Disturbance appearing as the primary indexed condition, and to 2 interventions - of which BrainSonix Pulsar 1002 is the first listed.
NCT07190287 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT07190287 about?
NCT07190287 is a clinical study titled "Wearable Neural Interfacing System for REM Sleep Restoration and Enhancement". 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 sl...
What is the current status of trial NCT07190287?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2025-07-15. Estimated completion is 2025-10-03.
What conditions does trial NCT07190287 study?
This clinical trial studies the following conditions: Sleep Disturbance, Stress, Psychological, REM Sleep Measurement.
What interventions are being tested in trial NCT07190287?
The interventions under investigation include: BrainSonix Pulsar 1002 (DEVICE), NEUSleeP system (FUS-EEG wearable device) (DEVICE).
Who is sponsoring clinical trial NCT07190287?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07190287 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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