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Sleep disorder may hold key to predicting Parkinson's before symptoms start

NCT ID NCT07729748

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This study investigates whether a combination of brain MRI scans, sleep recordings, and cognitive tests can track early brain changes in people with idiopathic REM sleep behavior disorder (iRBD), a condition that often precedes Parkinson's disease. Researchers will follow 50 people with iRBD and 50 healthy volunteers for three years, collecting data annually. The goal is to build a model that predicts which individuals are most likely to develop Parkinson's, potentially enabling earlier diagnosis and future preventive treatments.

What this could mean

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

What this could lead to
If successful, this could lead to a way to identify people at high risk of developing Parkinson's disease years before motor symptoms appear, enabling earlier intervention.
What could go wrong
This is an observational study, not a treatment trial. It may not produce a reliable prediction model, and findings may not apply to all populations.

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 100 people

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

Started

Dec 2020

Expected to finish

Aug 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

Patients with PSG-confirmed longstanding iRBD (duration since diagnosis greater than or equal to 5 years) recruited from outpatient patients of the Department of Neurology, San Raffaele Hospital, Turro, Milan, Italy. Healthy controls recruited among non-consanguineous relatives, institute personnel and by word of mouth.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 (both patients and healthy controls): 1. Right-handed participants. 2. Monolingual native Italian speakers. 3. Age between 50 and 75 years old. 4. Normal or corrected-to-normal visual acuity. 5. Mini Mental State Examination (MMSE) score greater than 24. 6. Oral and written informed consent to study participation. Additional inclusion criteria for iRBD patients: 7. Diagnosis of iRBD based on International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria: presence of REM sleep without atonia; presence of sleep-related injurious-disruptive behaviors by history or abnormal sleep behaviors documented during PSG monitoring; absence of EEG epileptiform activity during REM sleep; presence of sleep disturbance not better explained by another sleep disorder, medical or neurologic disorder, mental disorder, medication use, or substance use disorder. 8. PSG-confirmed iRBD duration since diagnosis equal or greater than 5 years. 9. Absence of clinically defined Parkinson's disease. Exclusion Criteria for iRBD patients: 1. Secondary forms of RBD on the basis of historical data, neurologic examination, and cerebral MRI findings. 2. History of other systemic, neurologic, or psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at MRI scan. 3. Alcohol and/or psychotropic drugs abuse. 4. Contraindications to MRI scan (cardiac pace-maker or other types of cardiac catheters, splinters or metallic shards, metallic prosthesis not compatible with the magnetic field generated by MRI, claustrophobia). Exclusion Criteria for Healthy Controls: 1. Sleep disorders on the basis of clinical evaluation. 2. History of systemic, neurologic, or psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at MRI scan. 3. Alcohol and/or psychotropic drugs abuse. 4. Contraindications to MRI scan (cardiac pace-maker or other types of cardiac catheters, splinters or metallic shards, metallic prosthesis not compatible with the magnetic field generated by MRI, claustrophobia). 5. Hypnotic or benzodiazepine medication.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • San Raffaele Hospital - Sleep Disorders Center, Department of Neurology, Turro

    Milan, Milano, 20127, Italy

  • San Raffaele Neurology Unit - Neuroimaging Research Unit

    Milan, Milano, 20132, Italy

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