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Study initiation package (dBM-DEV study)

14 Aug 2025

Study initiation package sets the stage for validating digital biomarkers in Parkinson’s disease

The Digital biomarkers development, validation and verification study (dBM-DEV study) – AI-PROGNOSIS first clinical study – is now underway, focusing on identifying digital biomarkers for REM Sleep Behaviour Disorder (RBD) and daytime somnolence through home-based assessment.


With ethics approvals secured, materials finalised, and clinical registration in place, participant enrolment is in progress across multiple study sites.


The study initiation package outlines the protocol, consent materials, regulatory status, and core procedures.


Read the full report on Zenodo: https://zenodo.org/records/15542563

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