Sleep study could unlock secrets of Parkinson's progression
NCT ID NCT07533799
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 650 people with early Parkinson's disease or a sleep condition called idiopathic REM sleep behavior disorder (iRBD). Researchers use brain scans, heart tests, and fluid samples to track changes over time. The goal is to better understand how these conditions develop and find markers that predict progression.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 650 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Jun 2033
An estimate. End dates often move.
- Lead sponsor
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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
Individuals with iRBD: Community-based, not restricted to geographical location. But fluency in Swedish and availability to attend repeated visits over the course of 72 months at the site in Malmö, Sweden, is required. Early Parkinson's disease: Patient from the Neurologic clinic at Skåne University Hospital, Sweden. Also patients from other neurological clinics in the county of Skåne, Sweden. Healthy controls: Community-based in the surroundings of Skåne University Hospital, Sweden.
- Ages
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50 to 100 years
- Sex
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Anyone
- Healthy volunteers
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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: Idiopathic RBD: * Polysomnography verified RBD according to AASM criteria. * Does not fulfill diagnostic criteria for idiopathic Parkinson´s disease. * Age range 50-100. Women who are \<55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal. * Ability to give informed consent. * Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests. Early Parkinson´s disease: * Fulfills the diagnostic criteria for idiopathic Parkinson´s disease. * The PD patients will be de novo (yet without any PD treatment) or with treatment for a maximum of 3 years. * Age range 50-100. Women who are \<55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal. * Ability to give informed consent. * Speaks Swedish fluently as stated above. Healthy Controls * Age range 50-100. Women who are \<55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal. * No diagnosis of PD or another significant neurological disorder. * No diagnosis of RBD. * Ability to give informed consent. * Speaks Swedish fluently as stated above. Exclusion Criteria: For all groups: * Past history of severe or repeated concussive head injury or stroke or any significant systemic disease or unstable medical condition. * History of severe and unstable depression, schizophrenia, schizoaffective disorder or bipolar disorder. * Significant white matter microvascular disease. * Contraindication to MRI and PET. Exclusion criteria specific for early Parkinson´s disease: * Normal dopamine transporter (\[18F\]FE-PE2I) scan.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Skane University Hospital
RECRUITINGMalmö, 392 33, Sweden
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Other studies related to the condition(s) this trial covers.
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