Pain Assessment in Patients With Idiopathic Rapid Eye Movement (REM) Sleep Behaviour Disorder (NCT07365566) | Clinical Trial Compass
RecruitingNot Applicable
Pain Assessment in Patients With Idiopathic Rapid Eye Movement (REM) Sleep Behaviour Disorder
France24 participantsStarted 2026-02-24
Plain-language summary
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease, with over 12 million patients expected globally by 2040. The disease is currently diagnosed at the appearance of motor symptoms, but by then, over 60% of striatal dopaminergic neurons have already been destroyed. Prodromal symptoms such as idiopathic REM Sleep Behavior Disorder (iRBD), anosmia, mood disorders and constipation appear earlier and are listed as criteria for a prodromal PD diagnosis. Identifying early signs is critical to initiate neuroprotective treatments as early as possible. While pain is prevalent and highly disabling in early PD, no data are currently available on pain perception in iRBD patients, whose condition is of the main risk factor for PD development.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Diagnosed with iRBD confirmed by polysomnography;
* No clinical diagnosis of Parkinson's disease or other diagnosis of neurodegenerative disease;
* Ability to understand and complete study procedures and questionnaires;
Control group:
* Diagnosed with narcolepsy type 1;
* Coexisting REM sleep behavior disorder confirmed by polysomnography;
* Ability to understand and complete study procedures and questionnaires;
Exclusion Criteria:
* Diagnosed Parkinson's Disease, dementia with Lewy bodies or multiple system atrophy;
* Severe depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM V);
* Inability to complete study procedures or questionnaires.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is comparing pain levels in people with iRBD versus a control group rather than testing a new treatment, what would my participation actually involve, and could it help doctors better understand my symptoms even if it doesn't directly change my care?
2I've been diagnosed with iRBD — does my doctor think my chronic pain symptoms, if I have any, might be connected to my condition in a way that makes this kind of study relevant to my situation?
3Because this is listed as Phase NA, meaning it's an observational or measurement study rather than a drug or device trial, are there any risks to me personally in taking part, or is it mainly a matter of time and logistics?
4The study also includes people with Narcolepsy Type 1 as a comparison group — does my doctor think my specific diagnosis puts me in the iRBD group being studied, and how would that affect what the researchers would be asking of me?
5If I join this study and the researchers find a link between iRBD and chronic pain, how might those findings eventually influence the way my condition is managed, and is there anything my doctor would recommend in the meantime regardless of whether I participate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of the intensity of chronic pain between patients with iRBD and a control group of patients