Sleep disorder may hold key to predicting Parkinson's before symptoms start
NCT ID NCT07729748
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Idiopathic rem sleep behavior disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a massive data registry crack the code of Parkinson's and related brain diseases?
- Reading the Brain's signals to predict who benefits from deep brain stimulation
- Giving Parkinson's patients a say may boost their Brain's ability to learn movement
- Brain scans probe why some Parkinson's patients freeze Mid-Step
- Can tango rewire the brain? dance program tested for Parkinson's and dementia
- Can a workout after walking practice help Parkinson's patients learn better?