Status:
COMPLETED
Wearable Neural Interfacing System for REM Sleep Restoration and Enhancement
Lead Sponsor:
University of Texas at Austin
Conditions:
Sleep Disturbance
Stress, Psychological
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 (...
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 (...
Eligibility Criteria
Inclusion
- 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 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.
Exclusion
Key Trial Info
Start Date :
July 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT07190287
Start Date
July 15 2025
End Date
October 3 2025
Last Update
October 7 2025
Active Locations (1)
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1
UT Austin, Biomedical Engineering Department
Austin, Texas, United States, 78712