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

NCT06270290 | Recruiting

• 1 other identifier: 327648
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

REM Sleep Behavior Disorder; Concussion, Brain

Keywords

REM sleep behaviour disorder; concussion; contact sports

Outcome Measures

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).

  1 year

Secondary Outcomes (2)

• Differences in concussions characteristics between RBD and control participants.

  1 year

• Demographic or clinical differences between RBD participants with and without concussions history.

  1 year

Study Arms (2)

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

Exposure to contact sports or history of concussions OTHER

History of contact sports practices or of concussions

Control group; RBD group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patient at the SDC with diagnosis of RBD (Guy's and St Thomas' NHS Foundation Trust).
• 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.
• years of age or above This group will be age- and sex-matched to the RBD group.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, London, SE1 9RT, United Kingdom

RECRUITING

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Brain Concussion

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Gillian Radcliffe

  Guys and St. Thomas NHS Foundation Hospital

  STUDY CHAIR

Central Study Contacts

Laura Pérez-Carbonell, PhD

CONTACT

02071883430; laura.perezcarbonell@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: April 23, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

GB (1)