Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Sleep Disturbance and Stress, Psychological, sponsored by University of Texas at Austin.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT07190287 record still lists
NCT07190287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 177-participant average among 56 other Sleep Disturbance trials with a reported enrollment target (71% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Sleep Disturbance
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07190287's enrollment target sits among peer trials
52 40th of 56 higher than 17 of 56 other Sleep Disturbance trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Disturbance trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Adjunctive Bright Light Therapy for Opioid Use Disorder
RECRUITING · NA
-
The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies
RECRUITING · NA
-
Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia
RECRUITING · NA
-
Sleep Promotion Program Primary Care
RECRUITING · NA
-
VR-PMR for Post-Burn Symptoms
RECRUITING · NA
-
SPARK Healthy Sleep
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02630121 · 52 participants · Phase 4
Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea
- NCT03629171 · 52 participants · Phase 2
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
- NCT04128748 · 52 participants · Phase 1
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
- NCT04150497 · 52 participants · Phase 1
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI