REM Sleep Behavior DisorderCOSP-RBDNCT06270290
The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls
An observational study of REM Sleep Behavior Disorder and Concussion, Brain, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- REM Sleep Behavior Disorder, Concussion, Brain
- What is being tested?
- Exposure to contact sports or history of concussions
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Apr 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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).
Who may be able to join
- 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.
Who cannot join
- Age < 50 years of age.
- Diagnoses of narcolepsy or post-traumatic stress disorder.
- Subjects lacking capacity or literacy.
- Non-English speakers.
- Age < 50 years of age (in order to match RBD group).
- REM sleep without atonia or confirmed RBD on v-PSG.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's & St Thomas' NHS Foundation Trust
London, London, SE1 9RT
Gill Radcliffe, 02071888070, gillian.radcliffe@gstt.nhs.uk
About this study
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)
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.
Read the 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 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.
- Conditions
- REM Sleep Behavior Disorder, Concussion, Brain
- Being tested
- Exposure to contact sports or history of concussions
- Keywords
- REM sleep behaviour disorder, concussion, contact sports
- Medical subject headings
- REM Sleep Behavior Disorder, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to contact sports or history of concussionsOther
History of contact sports practices or of concussions
| Study group | Role | What they receive |
|---|---|---|
| RBD group | Participants with a diagnosis of REM sleep behaviour disorder Receives: Other: Exposure to contact sports or history of concussions | |
| Control group | Participants without a diagnosis of REM sleep behaviour disorder Receives: Other: Exposure to contact sports or history of concussions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start23 Apr 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gillian Radcliffe, Study chair, Guys and St. Thomas NHS Foundation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270290
- Sponsor's protocol ID
- 327648
- Acronym
- COSP-RBD
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06270290
- Acronym / sponsor ID
- COSP-RBD / 327648
- Conditions
- REM Sleep Behavior Disorder, Concussion, Brain
- Keywords
- REM sleep behaviour disorder, concussion, contact sports
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBD group | – | Other: Exposure to contact sports or history of concussionsParticipants with a diagnosis of REM sleep behaviour disorder |
| Control group | – | Other: Exposure to contact sports or history of concussionsParticipants without a diagnosis of REM sleep behaviour disorder |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Age < 50 years of age.
- Diagnoses of narcolepsy or post-traumatic stress disorder.
- Subjects lacking capacity or literacy.
- Non-English speakers.
- Age < 50 years of age (in order to match RBD group).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to contact sports or history of concussionsHistory of contact sports practices or of concussions | Other | Control group, RBD group |
Primary outcome
Proportion of history of contact sports practice / concussion in RBD and control participants.
Time frame: 1 year
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).
2 secondary outcomes
Differences in concussions characteristics between RBD and control participants.
Time frame: 1 year
Demographic or clinical differences between RBD participants with and without concussions history.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gillian Radcliffe study chair
Guys and St. Thomas NHS Foundation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of REM Sleep Behavior Disorder and Concussion, Brain, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Pérez-Carbonell, PhD (02071883430, laura.perezcarbonell@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of history of contact sports practice / concussion in RBD and control participants. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.