The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls (NCT06270290) | Clinical Trial Compass
RecruitingNot Applicable
The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls
United Kingdom140 participantsStarted 2024-04-23
Plain-language summary
The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD).
The main questions it aims to answer are:
* What is the proportion of patients with RBD that have a history of concussions or exposure to contact sports?
* Is this proportion higher to that in control patients without a diagnosis of RBD?
Participants will undergo an interview with a sleep medicine specialist to answer questions about history of concussions and contact sports practices.
Researchers will compare an RBD group and a control group (without RBD) to see if the proportion of concussions and exposure to contact sports differ.
Who can participate
Age range
50 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 group with RBD:
* Patient at the SDC with diagnosis of RBD (Guy's and St Thomas' NHS Foundation Trust).
* 50 years of age or above (patients below this age would not be expected to have a RBD related to a synucleinopathy and other causes of RBD would need to be considered instead - e.g. narcolepsy, post-traumatic stress disorder).
Inclusion criteria control group:
* Patients who have undergone a v-PSG at the SDC (Guy's and St Thomas' NHS Foundation Trust) and who do not have history of suspected RBD or RBD confirmed by v-PSG.
* 50 years of age or above This group will be age- and sex-matched to the RBD group.
Exclusion criteria group with RBD:
* Age \< 50 years of age.
* Diagnoses of narcolepsy or post-traumatic stress disorder.
* Subjects lacking capacity or literacy.
* Non-English speakers.
Exclusion criteria control group:
* Age \< 50 years of age (in order to match RBD group).
* REM sleep without atonia or confirmed RBD on v-PSG.
* Diagnosis of neurological diseases, cognitive complaints or motor complaints.
* Clinical history suggestive of parasomnia that may be included in the differential of RBD.
* Subjects lacking capacity or literacy.
* Non-English speakers.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Proportion of history of contact sports practice / concussion in RBD and control participants.