NCT06270290 The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls
| NCT ID | NCT06270290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust |
| Condition | REM Sleep Behavior Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-04-23 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2024-04-23 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Gillian Radcliffe
STUDY CHAIR
Guys and St. Thomas NHS Foundation Hospital
Frequently Asked Questions
Who can join the NCT06270290 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying REM Sleep Behavior Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06270290 currently recruiting?
Yes, NCT06270290 is actively recruiting participants. Contact the research team at laura.perezcarbonell@gstt.nhs.uk for enrollment information.
Where is the NCT06270290 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06270290 clinical trial?
NCT06270290 is sponsored by Guy's and St Thomas' NHS Foundation Trust. The principal investigator is Gillian Radcliffe at Guys and St. Thomas NHS Foundation Hospital. The trial plans to enroll 140 participants.