Pain testing for people with idiopathic REM sleep behavior disorder
Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder
This study will test whether people with idiopathic REM sleep behavior disorder feel and report pain differently using brief thermal pain tests and questionnaires.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT07365566 on ClinicalTrials.gov |
What this trial studies
Researchers will recruit people with polysomnography-confirmed idiopathic REM sleep behavior disorder and a control group of patients with narcolepsy type 1 who have coexisting REM sleep behavior disorder. Participants will complete standardized pain questionnaires and undergo quantitative thermal pain testing to measure pain thresholds and responses; motor symptom evaluations are not part of the protocol. The aim is to characterize pain perception in iRBD as a possible prodromal feature of Parkinson disease and to compare it with a control population. Results will inform whether pain measures could help identify early neurodegenerative changes or improve symptom management.
Who should consider this trial
Good fit: Adults with polysomnography-confirmed idiopathic REM sleep behavior disorder, no clinical diagnosis of Parkinson disease or other neurodegenerative disorder, and the ability to complete testing and questionnaires are ideal candidates.
Not a fit: People already diagnosed with Parkinson disease, dementia with Lewy bodies, multiple system atrophy, those with severe depression, or anyone unable to complete the procedures are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could identify pain-related changes that help detect people at higher risk of Parkinson disease earlier and guide better pain care in prodromal stages.
How similar studies have performed: Pain is well described in early Parkinson disease, but pain perception specifically in iRBD is largely unstudied, making this an exploratory and relatively novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toulouse
- Centre Expert Parkinson Hôpital Pierre Paul Riquet Place du Docteur Baylac — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Christine BREFEL COURBON
- Email: christine.brefel-courbon@univ-tlse3.Fr
- Phone: 05 61 77 60 39
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.