The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorGuy's and St Thomas' NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
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.
Disqualifiers
Age < 50 years of age.
Diagnoses of narcolepsy or post-traumatic stress disorder.
Subjects lacking capacity or literacy.
Non-English speakers.
Trial population
Patients with a diagnosis of RBD at the Sleep Disorders Centre (Guy's and St Thomas' NHS Foundation Trust) will be identified via the sleep clinics. Expected number of eligible participants are 100, from which we expect 80 to agree to participate. An age- and sex-matched control group of 60 participants will be obtained also via the Sleep Disorders Centre clinics (Guy's and St Thomas' NHS Foundation Trust).
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Exposure to contact sports or history of concussions
Other interventionHistory of contact sports practices or of concussions
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: RBD group1 intervention
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
Proportion of history of contact sports practice / concussion in RBD and control participants.
Proportion of self-reported history of concussions or exposure to contact sports in participants with v-PSG-confirmed RBD and that in a control group (without a diagnosis of RBD).
Time frame
1 yearSecondary outcomes
1
Differences in concussions characteristics between RBD and control participants.
Concussions/head impact characteristics differences (as per interview designed for this study) in RBD and control participants.
Time frame
1 year2
Demographic or clinical differences between RBD participants with and without concussions history.
Demographic and clinical differences between RBD participants with and without history of concussions/head impact: age, sex, age at RBD onset and diagnosis, cardiovascular comorbidities, antidepressant or betablocker use at RBD onset, smoking status, alcohol intake, history of recreational substance misuse, history of sport-related supplements or substances use, education level, family history of neurodegenerative conditions, diagnosis of established neurodegenerative condition, time since diagnosis of RBD to neurodegenerative condition.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov