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Sleep study could unlock secrets of Parkinson's progression

NCT ID NCT07533799

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 650 people

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

Started

Oct 2021

Expected to finish

Jun 2033

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

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

50 to 100 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: 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.

  1. The places running it

    1 site. 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

  • Skane University Hospital

    RECRUITING

    Malmö, 392 33, Sweden

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