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Smartwatch AI could spot Parkinson's years before symptoms

NCT ID NCT07706829

Knowledge-focused Sponsor: Queen Mary University of London Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study tests whether an artificial intelligence model can estimate a person's risk of developing Parkinson's disease. Participants aged 50 and older who have certain early warning signs—like REM sleep behavior disorder, drops in blood pressure upon standing, or reduced sense of smell—wear a smartwatch and use a phone app for six months. The AI combines this digital data with clinical and genetic information to see how well it predicts brain changes linked to Parkinson's.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
smartwatch and phone app
What this could lead to
If successful, this could lead to a simple, non-invasive way to identify people at high risk for Parkinson's disease before major symptoms appear.
What could go wrong
This is an early, small proof-of-concept study. The AI model may not be accurate enough, and results may not apply to the general population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anosmia Parkinson disease primary orthostatic hypotension REM sleep behavior disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyposmia Neurogenic orthostatic hypotension Parkinson disease (PD) Rem sleep behavior disorder (IRBD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, France

  • Fundación Iniciativa para las Neurociencias. Hospital Ruber Internacional.

    Madrid, Spain

  • Queen Mary University of London

    London, United Kingdom

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