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First received: July 31, 2025

Clinical Trial: Wearable Neural Interfacing System for REM Sleep Restoration and Enhancement

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Sleep Disturbance

Study Type: INTERVENTIONAL


Official Title: Evaluation of a Wearable EEG-tFUS System for REM Sleep Modulation in Healthy Adults and Individuals With Subclinical Sleep Disturbances

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 (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…

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