At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Exposure to contact sports or history of concussions (other)
- How long the study runs
- Study runs about 29 months (dates as stated)
- About the drug or intervention
- Exposure to contact sports or history of concussions — other: History of contact sports practices or of concussions
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 50 Years and over
- Who
- All
- Number of participants
- 140
- Started
- 2024-04-23
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for rem sleep behavior disorder
- • Clinical study - 140 participants
- • The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD)
Who can take part?
- • Ages 50 Years and over
- • Diagnosed with rem sleep behavior disorder
Where?
- • London - Guy's & St Thomas' NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
Rapid eye movement (REM) sleep behaviour disorder (RBD) is a parasomnia characterised by the presence of acting-out behaviours in sleep and vivid dreams, which diagnosis requires the demonstration of loss of REM atonia or an RBD episode on a video-polysomnography (v-PSG). Importantly, patients with the isolated form of RBD are at a high risk to develop Parkinson's disease or related neurodegenerative conditions, such as dementia with Lewy bodies or multiple system atrophy (synucleinopathies). Hence, RBD is a condition frequently associated to, and often preceding, a manifest neurodegenerative disorder. It is therefore extremely relevant to identify factors that may be linked to these early neuropathological processes. This will be key for a timely diagnosis of isolated RBD, especially when neuroprotective trials become available. There is also solid evidence showing that repeated concussions lead to an increased risk to develop a neurodegenerative disorder such as Parkinson's disease, chronic traumatic encephalopathy, all-causes of dementia, and amyotrophic lateral sclerosis. In epidemiological studies, self-reported head injury was more frequently present in RBD vs controls. Head injury was also proposed as a possible risk factor for probable RBD in large community-based studies, although the diagnosis of RBD was not confirmed by v-PSG in these cases. Of note, a higher frequency of professional football players was demonstrated on a recent study including a large cohort of RBD patients when compared to a control group. Moreover, in a group of deceased contact sport athletes with neuropathology diagnosing traumatic chronic encephalopathy, probable RBD was present in over 30% of the sample. We hypothesise that the presence of a history of concussions or exposure to contact sports is more frequently reported by patients with v-PSG-confirmed RBD than by sex- and age-matched controls. There is, however, a lack of further characterisation of the head-impact events and circumstances in which they have occurred. It would be relevant to know whether repeated head impacts while playing contact sports or concussions that may have not been formally diagnosed, and that may have happened in non-professional as well as in professional sport activities, may be linked with RBD. The demonstration of a higher percentage of concussions or exposure to contact sports in RBD would provide greater evidence related to neuropathological changes in the context of certain sport practices. Given the prognostic implications of a diagnosis of RBD and the established links between head injury and neurodegenerative conditions, it seems relevant to assess the characteristics of previous concussions or exposure to head-impact sports in patients with v-PSG-confirmed RBD. This will provide further evidence to help increase the awareness of RBD (hopefully leading to a more timely diagnosis of this condition), and potentially aid the development of health and government policies, including those relating to safer sport practices. As one of the major sleep disorders centres in the UK, and one of the few with expertise in sleep neurological conditions such as RBD, it is our responsibility to assess and report our experience on this matter. The primary objective of this study is to assess the frequency of self-reported history of concussions or exposure to contact sports in patients with v-PSG-confirmed RBD against a control group (without a diagnosis of RBD). Secondary objectives of this study will include investigating concussions/head impact characteristics in RBD vs control group. We will also aim to search differences in demographic and clinical variables between RBD patients with and without history of concussions/head impact.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years and over
- Who can join: All genders
What the study is looking for
- ✓Inclusion criteria group with RBD:
- ✓Patient at the SDC with diagnosis of RBD (Guy's and St Thomas' NHS Foundation Trust).
- ✓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...
- ✓50 years of age or above This group will be age- and sex-matched to the RBD group.
See the full criteria
Where Is This Study? (1 UK site)
Guy's & St Thomas' NHS Foundation Trust
London SE1 9RT, United Kingdom
How to Get in Touch
Laura Pérez-Carbonell, PhD
Sponsor contactCONTACT
