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

Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07365566
Acronym
PAIN-iRBD
Enrollment
24
Registered
2026-01-26
Start date
2026-02-24
Completion date
2026-08-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy Type 1, REM Sleep Behavior Disorder (iRBD)

Keywords

parkinson, REM sleep, pain, REM sleep behavior disorder, narcolepsy Type 1, sleep

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.

Interventions

OTHERThermo 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.

Patients will complete various questionnaires about pain

OTHERNo motors symptoms evaluations

Patients will complete questionnaires

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the intensity of chronic pain between patients with iRBD and a control group of patients2 hours after the inclusionMeasuring 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).

Secondary

MeasureTime frameDescription
Describe semiological characteristics of pain in RBD patients2 hours after the inclusionDescription of characteristics of pain
Compare the presence of chronic pain2 hours after the inclusionNumber of patients with chronic pain in both groups for at least 3 months.
Assessing Pain Characteristics2 hours after the inclusionScore obtained on pain questionnaires
Assessment of thermal pain threshold and tolerance2 hours after the inclusionResults of the quantitative sensory test (thermal thermotest) in both groups
Assessment of correlations between the intensity of chronic pain2 hours after the inclusionCorrelation between Visual Analogue Scale (VAS) measurements and questionnaire responses

Countries

France

Contacts

CONTACTChristine BREFEL COURBON
christine.brefel-courbon@univ-tlse3.Fr05 61 77 60 39

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026