Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06270290 |
| Other study ID # |
327648 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 23, 2024 |
| Est. completion date |
March 30, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Guy's and St Thomas' NHS Foundation Trust |
| Contact |
Laura Pérez-Carbonell, PhD |
| Phone |
02071883430 |
| Email |
laura.perezcarbonell[@]gstt.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
