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RecruitingNCT06270290COSP-RBDUpdated Jun 4, 2026

The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls

An observational study in REM Sleep Behavior Disorder and Concussion, Brain, sponsored by Guy's and St Thomas' NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
140
Ages
50 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • REM Sleep Behavior Disorder
  • Concussion, Brain

Keywords

  • REM sleep behaviour disorder
  • concussion
  • contact sports
03

In context

REM Sleep Behavior Disorder

101 studies on the registry are indexed under REM Sleep Behavior Disorder; 45 are open to participants now.

This study's planned enrollment of 140 is above the median of 119 across 48 observational studies indexed under REM Sleep Behavior Disorder.

Browse REM Sleep Behavior Disorder studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 295 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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).

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
140 participants (estimated)
Patient registry
No

Groups and cohorts

  • RBD group

    Participants with a diagnosis of REM sleep behaviour disorder

    Other: Exposure to contact sports or history of concussions

  • Control group

    Participants without a diagnosis of REM sleep behaviour disorder

    Other: Exposure to contact sports or history of concussions

Interventions

  • OtherExposure to contact sports or history of concussions

    History of contact sports practices or of concussions

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2024 (actual). Primary completion is estimated for Sep 2026, 29 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2024
First posted
Feb 21, 2024
StartActual
Apr 23, 2024
Primary completionEst.
Sep 30, 2026
CompletionEst.
Sep 30, 2026
Last update
Jun 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06270290
Responsible party
Sponsor
First posted
Feb 21, 2024
Start date
Apr 23, 2024
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jun 4, 2026

Study contacts

Laura Pérez-Carbonell, PhD
Contact
laura.perezcarbonell@gstt.nhs.uk
02071883430
Gillian Radcliffe
study chair · Guys and St. Thomas NHS Foundation Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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