NCT07365566 Pain Assessment in Patients With Idiopathic Rapid Eye Movement (REM) Sleep Behaviour Disorder
| NCT ID | NCT07365566 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | REM Sleep Behavior Disorder (iRBD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-02-24 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-02-24 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease, with over 12 million patients expected globally by 2040. The disease is currently diagnosed at the appearance of motor symptoms, but by then, over 60% of striatal dopaminergic neurons have already been destroyed. Prodromal symptoms such as idiopathic REM Sleep Behavior Disorder (iRBD), anosmia, mood disorders and constipation appear earlier and are listed as criteria for a prodromal PD diagnosis. Identifying early signs is critical to initiate neuroprotective treatments as early as possible. While pain is prevalent and highly disabling in early PD, no data are currently available on pain perception in iRBD patients, whose condition is of the main risk factor for PD development.
Eligibility Criteria
Inclusion criteria: * Diagnosed with iRBD confirmed by polysomnography; * No clinical diagnosis of Parkinson's disease or other diagnosis of neurodegenerative disease; * Ability to understand and complete study procedures and questionnaires; Control group: * Diagnosed with narcolepsy type 1; * Coexisting REM sleep behavior disorder confirmed by polysomnography; * Ability to understand and complete study procedures and questionnaires; Exclusion Criteria: * Diagnosed Parkinson's Disease, dementia with Lewy bodies or multiple system atrophy; * Severe depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM V); * Inability to complete study procedures or questionnaires.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07365566 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying REM Sleep Behavior Disorder (iRBD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07365566 currently recruiting?
Yes, NCT07365566 is actively recruiting participants. Contact the research team at christine.brefel-courbon@univ-tlse3.Fr for enrollment information.
Where is the NCT07365566 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT07365566 clinical trial?
NCT07365566 is sponsored by University Hospital, Toulouse. The trial plans to enroll 24 participants.