Not_yet_recruitingNCT07706829

Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study

Sponsor: Queen Mary University of London

Trial Details

ConditionParkinson Disease (PD), REM Sleep Behavior Disorder (iRBD), Neurogenic Orthostatic Hypotension, Hyposmia
InterventionSmartwatch and phone app
StatusNot_yet_recruiting
Participants60
Est. Completion30 Sept 2027
Last Updated20 July 2026

Primary Outcome

Classification performance of the PD risk artificial intelligence-based model

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1. Age ≥ 50 years. 2. At least one of the following clinical markers for PD risk: 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. 3. Able and willing to give informed written consent. 4. Use of compatible smartphone (mobile operating system Android version 11 or newer). A smartwatch will be provided to each participant for the duration of the study. Exclusion Criteria: 1. Clinical diagnosis of Parkinson's disease (PD) according to MDS clinical diagnostic criteria. 2. 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). 3. Dementia defined as deterioration of cognitive function severe enough to impair functioning on daily activities. 4. 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. 5. Pregnant women. 6. Concomitant participation in interventional studies. 7. Unwilling or unable to give informed written consent. 8. Vulnerable individuals as defined by the HRA. 9. Inability to use the smartwatch and/or the mAI-Health app for the purpose of the study as judged by the investigator.

Trial Sites

Countries

FranceSpainUnited Kingdom
View Registry Entry

This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service