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

NCT07365566 | Recruiting DMC

• 2 other identifiers: RC31/25/0567ID-RCB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

REM Sleep Behavior Disorder (iRBD); Narcolepsy Type 1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Comparison of the intensity of chronic pain between patients with iRBD and a control group of patients

  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).

  2 hours after the inclusion

Secondary Outcomes (5)

• Describe semiological characteristics of pain in RBD patients

  2 hours after the inclusion

• Compare the presence of chronic pain

  2 hours after the inclusion

• Assessing Pain Characteristics

  2 hours after the inclusion

• Assessment of thermal pain threshold and tolerance

  2 hours after the inclusion

• Assessment of correlations between the intensity of chronic pain

  2 hours after the inclusion

Study Arms (2)

Idiopathic REM sleep Behavior disorder (iRBD) Group

EXPERIMENTAL

Patients who have an idiopathic REM sleep Behavior Disorder

Other: Thermo test pain; Other: Pain questionnaires; Other: No motors symptoms evaluations

Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1

ACTIVE COMPARATOR

patients who have an iRBD and who have type 1 narcolepsy

Other: Thermo test pain; Other: Pain questionnaires; Other: No motors symptoms evaluations

Interventions

Thermo test pain OTHER

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

Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1; Idiopathic REM sleep Behavior disorder (iRBD) Group

Pain questionnaires OTHER

Patients will complete various questionnaires about pain

Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1; Idiopathic REM sleep Behavior disorder (iRBD) Group

No motors symptoms evaluations OTHER

Patients will complete questionnaires

Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1; Idiopathic REM sleep Behavior disorder (iRBD) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Centre Expert Parkinson Hôpital Pierre Paul Riquet Place du Docteur Baylac

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Pain

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christine BREFEL COURBON

CONTACT

05 61 77 60 39; christine.brefel-courbon@univ-tlse3.Fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)