Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270290
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-02-13
Brief Title:
The COSP-RBD Study Concussions and Contact Sports in RBD vs Controls
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Observational Cross-sectional Study Investigating the History of Concussion and Exposure to Contact Sports in Patients With REM Sleep Behaviour Disorder RBD Versus Controls Without a Diagnosis of RBD
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COSP-RBD
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
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
Detailed 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 Parkinsons 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 Parkinsons 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 concussionshead 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 concussionshead impact
There is also solid evidence showing that repeated concussions lead to an increased risk to develop a neurodegenerative disorder such as Parkinsons 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 concussionshead 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 concussionshead impact
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None