Ireland
--:--IST
Recruiting Not applicable

Pain Assessment in Patients With Idiopathic Rapid Eye Movement (REM) Sleep Behaviour Disorder

NCT07365566 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-02-24
Last updated
2026-05-01

Condition(s) studied

REM Sleep Behavior Disorder (iRBD)Narcolepsy Type 1

Investigational drug(s) / intervention(s)

Thermo test painPain questionnairesNo motors symptoms evaluations

Thermo test pain: Patients will undergo a pain test, also called a thermotest, which consists of determining pain thresholds using a thermometer applied to the hand.

Pain questionnaires: Patients will complete various questionnaires about pain

No motors symptoms evaluations: Patients will complete questionnaires

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Comparison of the intensity of chronic pain between patients with iRBD and a control group of patients — 2 hours after the inclusion
    Measuring the Visual Analog Scale (VAS) between patients with iRBD without diagnosis of PD and a control group of patients diagnosed with narcolepsy type 1 who present RBD (Rapid eye movement sleep behavior disorder).

Trial sites (1)

FacilityCityRegionStatus
Centre Expert Parkinson Hôpital Pierre Paul Riquet Place du Docteur Baylac Toulouse France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07365566 on ClinicalTrials.gov ↗ ← All trials in France