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NCT Number: NCT07365566

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

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.

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Key information

Conditions

REM Sleep Behavior Disorder (iRBD) Mental Disorders Narcolepsy Type 1 Nervous System Diseases Neurologic Manifestations Pain Parasomnias Pathological Conditions, Signs and Symptoms REM Sleep Behavior Disorder REM Sleep Parasomnias Signs and Symptoms Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Expert Parkinson Hôpital Pierre Paul Riquet Place du Docteur Baylac

Toulouse, 31059, France

Location status: Recruiting

Location contact

Emeline Muller

CONTACT

[email protected]

05 61 77 87 07 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Pain questionnaires

Other

Patients will complete various questionnaires about pain

No motors symptoms evaluations

Other

Patients will complete questionnaires

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

  1. Describe semiological characteristics of pain in RBD patients

    Time frame: 2 hours after the inclusion

    Description of characteristics of pain

  2. Compare the presence of chronic pain

    Time frame: 2 hours after the inclusion

    Number of patients with chronic pain in both groups for at least 3 months.

  3. Assessing Pain Characteristics

    Time frame: 2 hours after the inclusion

    Score obtained on pain questionnaires

  4. Assessment of thermal pain threshold and tolerance

    Time frame: 2 hours after the inclusion

    Results of the quantitative sensory test (thermal thermotest) in both groups

  5. Assessment of correlations between the intensity of chronic pain

    Time frame: 2 hours after the inclusion

    Correlation between Visual Analogue Scale (VAS) measurements and questionnaire responses

Study contacts

Contact information is provided by the study sponsor or research team.

Christine BREFEL COURBON

CONTACT

[email protected]

05 61 77 60 39 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder

Acronym: PAIN-iRBD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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