The study aims to provide initial proof-of-concept validation data of an artificial intelligence-based model to estimate individual Parkinson's disease risk using demographic, clinical, genetic information and digital biomarker data collected via a smartwatch and a mobile application.
Age ≥ 50 years.
REM sleep behaviour disorder (RBD) confirmed with polysomnography.
Neurogenic orthostatic hypotension (nOH) defined as a drop in systolic / diastolic blood pressure ≥ 20/10mmHg within 3 minutes of active standing or tilt-table test, and with a blunted heart rate response (ΔHeart rate/ΔSBP ratio < 0.5 bpm/mmHg).
Objective hyposmia defined as University of Pennsylvania Smell Identification Test (UPSIT) score ≤ 15th percentile for age and sex.
Clinical diagnosis of Parkinson's disease (PD) according to MDS clinical diagnostic criteria.
Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of investigator).
Dementia defined as deterioration of cognitive function severe enough to impair functioning on daily activities.
Active treatment with neuroleptics, reserpine or metoclopramide (these drugs should be discontinued for at least 6 months before screening visit) due to their interference with dopamine transporter SPECT imaging acquisition and interpretation.
People at risk of PD due to the presence of clinical markers associated with prodromal PD including one of the following: 1. REM sleep behaviour disorder (RBD) confirmed with polysomnography. 2. Neurogenic orthostatic hypotension (nOH) defined as a drop in systolic / diastolic blood pressure ≥ 20/10mmHg within 3 minutes of active standing or tilt-table test, and with a blunted heart rate response (ΔHeart rate/ΔSBP ratio \< 0.5 bpm/mmHg). 3. Objective hyposmia defined as University of Pennsylvania Smell Identification Test (UPSIT) score ≤ 15th percentile for age and sex.
Cohort
Prospective
Smartwatch and phone app
DeviceWearing a smartwatch and using a mobile phone application for 6 months in order to provide digital biomarker data and additional self reported clinical information.
Classification performance of the PD risk artificial intelligence-based model
Classification performance of the model in predicting dopaminergic degeneration defined as a binary outcome: a participant will be considered to have dopaminergic degeneration if putamen specific binding ratio (SBR) on the most affected side is below 2 standard deviations of age-matched normative data or shows abnormal visual inspection by a qualified nuclear medicine specialist on dopamine transporter SPECT imaging.
Usability of study digital environment (mAI-Health phone app)
System Usability Scale (SUS) scores. The SUS includes 10 statement items regarding the usability of the study phone application that will be rated on a scale of 1 - 5 (strongly disagree - strongly agree). Range 10-50 with higher scores meaning a better outcome.
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Queen Mary University of London
Lead sponsor
Hospital Ruber Internacional
Collaborator
University Hospital, Toulouse
Collaborator
Aristotle University Of Thessaloniki
Collaborator
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