REM Sleep Behavior Disorder (iRBD)PAIN-iRBDNCT07365566
Pain Assessment in Patients With Idiopathic Rapid Eye Movement (REM) Sleep Behaviour Disorder
A study testing Thermo test pain, Pain questionnaires and No motors symptoms evaluations in people with REM Sleep Behavior Disorder (iRBD) and Narcolepsy Type 1, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- REM Sleep Behavior Disorder (iRBD), Narcolepsy Type 1
- What is being tested?
- Thermo test pain, Pain questionnaires and No motors symptoms evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Expert Parkinson Hôpital Pierre Paul Riquet Place du Docteur Baylac
Toulouse, 31059
Emeline Muller, 05 61 77 87 07 ext. +33, muller.E@chu-toulouse.Fr
About this study
Official title: Pain Assessment in Patients With Idiopathic 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.
- Being tested
- Thermo test pain, Pain questionnaires, No motors symptoms evaluations
- Keywords
- parkinson, REM sleep, pain, REM sleep behavior disorder, narcolepsy Type 1, sleep
- Medical subject headings
- REM Sleep Behavior Disorder, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermo test painOther
Patients will undergo a pain test, also called a thermotest, which consists of determining pain thresholds using a thermometer applied to the hand.
Pain questionnairesOther
Patients will complete various questionnaires about pain
No motors symptoms evaluationsOther
Patients will complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic REM sleep Behavior disorder (iRBD) Group | Experimental | Patients who have an idiopathic REM sleep Behavior Disorder Receives: 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 Receives: Other: Thermo test pain; Other: Pain questionnaires; Other: No motors symptoms evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hours after the inclusion
Secondary outcomes (5)
Describe semiological characteristics of pain in RBD patients
Description of characteristics of pain
Measured: 2 hours after the inclusion
Compare the presence of chronic pain
Number of patients with chronic pain in both groups for at least 3 months.
Measured: 2 hours after the inclusion
Assessing Pain Characteristics
Score obtained on pain questionnaires
Measured: 2 hours after the inclusion
Assessment of thermal pain threshold and tolerance
Results of the quantitative sensory test (thermal thermotest) in both groups
Measured: 2 hours after the inclusion
Assessment of correlations between the intensity of chronic pain
Correlation between Visual Analogue Scale (VAS) measurements and questionnaire responses
Measured: 2 hours after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start24 Feb 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep Behavior Disorder (iRBD)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365566
- Sponsor's protocol ID
- RC31/25/0567
- Other IDs
- ID-RCB
- Acronym
- PAIN-iRBD
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder
- ClinicalTrials.gov ID
- NCT07365566
- Acronym / sponsor ID
- PAIN-iRBD / RC31/25/0567
- Keywords
- parkinson, REM sleep, pain, REM sleep behavior disorder, narcolepsy Type 1, sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic REM sleep Behavior disorder (iRBD) Group | Experimental | Other: Thermo test pain, Other: Pain questionnaires, Other: No motors symptoms evaluationsPatients who have an idiopathic REM sleep Behavior Disorder |
| Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1 | Active comparator | Other: Thermo test pain, Other: Pain questionnaires, Other: No motors symptoms evaluationspatients who have an iRBD and who have type 1 narcolepsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- Diagnosed with narcolepsy type 1;
- Coexisting REM sleep behavior disorder confirmed by polysomnography;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermo test painPatients will undergo a pain test, also called a thermotest, which consists of determining pain thresholds using a thermometer applied to the hand. | Other | Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1, Idiopathic REM sleep Behavior disorder (iRBD) Group |
| Pain questionnairesPatients will complete various questionnaires about pain | Other | Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1, Idiopathic REM sleep Behavior disorder (iRBD) Group |
| No motors symptoms evaluationsPatients will complete questionnaires | Other | Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1, Idiopathic REM sleep Behavior disorder (iRBD) Group |
Primary outcome
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).
5 secondary outcomes
Describe semiological characteristics of pain in RBD patients
Time frame: 2 hours after the inclusion
Compare the presence of chronic pain
Time frame: 2 hours after the inclusion
Assessing Pain Characteristics
Time frame: 2 hours after the inclusion
Assessment of thermal pain threshold and tolerance
Time frame: 2 hours after the inclusion
Assessment of correlations between the intensity of chronic pain
Time frame: 2 hours after the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermo test pain, Pain questionnaires and No motors symptoms evaluations in people with REM Sleep Behavior Disorder (iRBD) and Narcolepsy Type 1, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine BREFEL COURBON (05 61 77 60 39 ext. +33, christine.brefel-courbon@univ-tlse3.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the intensity of chronic pain between patients with iRBD and a control group of patients (time frame: 2 hours after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.