REM Sleep Behaviour DisorderSODISLEEPNCT05976971
Microstructural and Sodium 7 Tesla Brain MRI in Idiopathic REM Sleep Behaviour Disorder
A study testing 7T MRI in people with REM Sleep Behaviour Disorder, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
By 2030 the number of patients with Parkinson's Disease (PD) would increase by 56% affecting 1 out of 120 people older than 45 years-old. It is known that 10-15 years before the onset motor symptoms such as tremor, rigidity and akinesia, patients often experience a specific sleep trouble called REM sleep behaviour… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- REM Sleep Behaviour Disorder
- What is being tested?
- 7T MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2023to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient aged between 40 and 80 years old
- Score under or equal 4 for the RBD screening questionnaire
- UPDRS Part III score under or equal 5
- The patient is enrolled in the French social security system
- The patient understood and signed the consent to participate in the study.
Who cannot join
- Patient / Subject with a history of central nervous system disease (e.g. PD, Alzheimer's disease, stroke, brain tumour, multiple sclerosis, amyotrophic lateral sclerosis, etc.). If a doubt exist, this criterion will be left to the judgement of the principal investigator, who is a neurologist.
- Contraindications to 7T MRI: presence of a metal in the body or in the eye, patient with a pacemaker or neurostimulator, cochlear implants or any implanted electronic medical equipment in general, metallic heart valve, aneurysm clips.
- Claustrophobia.
- Montreal Cognitive Assessment Test (MOCA) < 25/30
- Pregnant or breast-feeding woman or protected person (under guardianship, curatorship, deprived of liberty).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microstructural Brain MRI Biomarkers in Patients With Idiopathic REM Sleep Behaviour Disorder at 7 Tesla
By 2030 the number of patients with Parkinson's Disease (PD) would increase by 56% affecting 1 out of 120 people older than 45 years-old. It is known that 10-15 years before the onset motor symptoms such as tremor, rigidity and akinesia, patients often experience a specific sleep trouble called REM sleep behaviour disorder (RBD). Follow-up of those subjects showed there was a conversion rate to PD and related disorders (called synucleinopathies) over 80%.
The pathophysiology of RBD is poorly understood. The development of cutting-edge technologies such as 7 Tesla MRI and the optimisation of image processing methods made it possible to non-invasively explore in vivo small brain structures involved in sleep and movement disorders.
Read more
The investigators hypothesize that brain and brainstem microstructure, composition, sodium homeostasis and connectivity may change in 15 isolated RBD (iRBD) subjects compared with 15 healthy controls and that these changes may be correlated with clinical scores.
This study would help fill the gap in early diagnosis of synucleinopathies, by contributing to better targeting patients who could be included in therapeutic trials with a neuroprotective effect. Besides, the exploration of original pathophysiological pathways such as sodium homeostatis could provide the necessary arguments for the development of new target therapeutics.
- Conditions
- REM Sleep Behaviour Disorder
- Being tested
- 7T MRI
- Keywords
- 7T MRI, Parkinson's disease, synucleinopathies
- Medical subject headings
- REM Sleep Behavior Disorder, Parkinson Disease, Synucleinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7T MRIOther
Also called Questionnaires
Subjects will have a 7T MRI and questionnaires on the only day of clinical study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with REM Sleep Behaviour Disorder | Other | Not described Receives: Other: 7T MRI |
| Healthy volunteers | Other | Not described Receives: Other: 7T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D cartography the rate of difference of atrophy between the idiopathic REM Sleep Behaviour Disorder (iRBD) and control subjects
Voxel based morphometry evaluated with Matlab and SnPM
Measured: Time of the Inclusion
3D cartography difference of neuromelanin between the iRBD and control subjects with T1 sequence
Neuromelanin contrast ratio
Measured: Time of the Inclusion
3D cartography difference of neuromelanin between the iRBD and control subjects with Magnetization transfert sequence
Magnetization transfert contrast ratio
Measured: Time of the Inclusion
3D cartography the rate of difference of Quantitative Susceptibility Mapping between the iRBD and control subjects
Iron load evaluation in ppb
Measured: Time of the Inclusion
3D cartography difference of Mean diffusivity between the iRBD and control subjects
Mean diffusivity in mm2/s
Measured: Time of the Inclusion
3D cartography difference of Fractional anisotropy between the iRBD and control subjects
Fractional anisotropy between 0 and 1
Measured: Time of the Inclusion
Secondary outcomes (21)
3D cartography difference of total sodium concentration between the iRBD and control subjects
total sodium concentration in mmol/L acquired with a specificic MRI coil
Measured: Time of the Inclusion
3D cartography difference of structural brain connectivity between the iRBD and control subjects
A network-based statistics analysis will be performed: from Diffusion tensor imaging, a connectivity matrix will be populated for each subject. A t-test contrasting the two groups (iRBD and control subjects) will then be computed for each pairwise association. Finally, permutation testing will be used to ascribe a p-value controlled for the family-wise error rate to each connected component based on its size.
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data
Pearson, Spearman or logistic regression, depending on the age and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data
Pearson, Spearman or logistic regression, depending on the sex and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data
Pearson, Spearman or logistic regression, depending on the laterality and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the MDS-UPDRS I (Movement disorders society - Unified Parkinson's Disease Rating Scale) scale and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the MDS-UPDRS II scale and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the MDS-UPDRS III scale and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the SCOPA-AUT scale and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the HAD scale (Hospital Anxiety and Depression scale) and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the RBD (Rem sleep behaviour disorder) and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the Pittsburgh sleep quality index and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the Starkstein motivation scale and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the non motor fluctuation scale and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the MoCA scale and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the phonemic and category fluencies and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the Benton judgement of lines and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the quality of life SF-36 and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the Miami Hallucinations questionnaire and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the treatement intake and MRI parameters
Measured: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the blood pressure test and MRI parameters
Measured: Time of the Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start30 Oct 2023
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep Behaviour DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- Aix Marseille Université
- Responsible party
- Sponsor
- Investigators
- Francois Cremieux, Study director, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976971
- Sponsor's protocol ID
- RCAPHM22_0397
- Other IDs
- ID-RCB
- Acronym
- SODISLEEP
- Status last verified
- Jan 2026
- First submitted
- 12 Jul 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microstructural Brain MRI Biomarkers in Patients With Idiopathic REM Sleep Behaviour Disorder at 7 Tesla
- ClinicalTrials.gov ID
- NCT05976971
- Acronym / sponsor ID
- SODISLEEP / RCAPHM22_0397
- Conditions
- REM Sleep Behaviour Disorder
- Keywords
- 7T MRI, Parkinson's disease, synucleinopathies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Collaborators
- Aix Marseille Université
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 4 Aug 2023 (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.
By 2030 the number of patients with Parkinson's Disease (PD) would increase by 56% affecting 1 out of 120 people older than 45 years-old. It is known that 10-15 years before the onset motor symptoms such as tremor, rigidity and akinesia, patients often experience a specific sleep trouble called REM sleep behaviour disorder (RBD). Follow-up of those subjects showed there was a conversion rate to PD and related disorders (called synucleinopathies) over 80%.
The pathophysiology of RBD is poorly understood. The development of cutting-edge technologies such as 7 Tesla MRI and the optimisation of image processing methods made it possible to non-invasively explore in vivo small brain structures involved in sleep and movement disorders.
The investigators hypothesize that brain and brainstem microstructure, composition, sodium homeostasis and connectivity may change in 15 isolated RBD (iRBD) subjects compared with 15 healthy controls and that these changes may be correlated with clinical scores.
This study would help fill the gap in early diagnosis of synucleinopathies, by contributing to better targeting patients who could be included in therapeutic trials with a neuroprotective effect. Besides, the exploration of original pathophysiological pathways such as sodium homeostatis could provide the necessary arguments for the development of new target therapeutics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with REM Sleep Behaviour Disorder | Other | Other: 7T MRI |
| Healthy volunteers | Other | Other: 7T MRI |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged between 40 and 80 years old
- Score under or equal 4 for the RBD screening questionnaire
- UPDRS Part III score under or equal 5
- The patient is enrolled in the French social security system
- The patient understood and signed the consent to participate in the study.
Key exclusion criteria (5 listed)
- Patient / Subject with a history of central nervous system disease (e.g. PD, Alzheimer's disease, stroke, brain tumour, multiple sclerosis, amyotrophic lateral sclerosis, etc.). If a doubt exist, this criterion will be left to the judgement of the principal investigator, who is a neurologist.
- Contraindications to 7T MRI: presence of a metal in the body or in the eye, patient with a pacemaker or neurostimulator, cochlear implants or any implanted electronic medical equipment in general, metallic heart valve, aneurysm clips.
- Claustrophobia.
- Montreal Cognitive Assessment Test (MOCA) < 25/30
- Pregnant or breast-feeding woman or protected person (under guardianship, curatorship, deprived of liberty).
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 |
|---|---|---|
| 7T MRIAlso: QuestionnairesSubjects will have a 7T MRI and questionnaires on the only day of clinical study. | Other | Healthy volunteers, Patients with REM Sleep Behaviour Disorder |
Primary outcome
3D cartography the rate of difference of atrophy between the idiopathic REM Sleep Behaviour Disorder (iRBD) and control subjects
Time frame: Time of the Inclusion
Voxel based morphometry evaluated with Matlab and SnPM
3D cartography difference of neuromelanin between the iRBD and control subjects with T1 sequence
Time frame: Time of the Inclusion
Neuromelanin contrast ratio
3D cartography difference of neuromelanin between the iRBD and control subjects with Magnetization transfert sequence
Time frame: Time of the Inclusion
Magnetization transfert contrast ratio
3D cartography the rate of difference of Quantitative Susceptibility Mapping between the iRBD and control subjects
Time frame: Time of the Inclusion
Iron load evaluation in ppb
3D cartography difference of Mean diffusivity between the iRBD and control subjects
Time frame: Time of the Inclusion
Mean diffusivity in mm2/s
3D cartography difference of Fractional anisotropy between the iRBD and control subjects
Time frame: Time of the Inclusion
Fractional anisotropy between 0 and 1
21 secondary outcomes
3D cartography difference of total sodium concentration between the iRBD and control subjects
Time frame: Time of the Inclusion
3D cartography difference of structural brain connectivity between the iRBD and control subjects
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Time frame: Time of the Inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 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. This study is not recruiting at the moment.
Francois Cremieux study director
Assistance Publique - Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7T MRI in people with REM Sleep Behaviour Disorder, run by Assistance Publique Hopitaux De Marseille 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D cartography the rate of difference of atrophy between the idiopathic REM Sleep Behaviour Disorder (iRBD) and control subjects (time frame: Time of the Inclusion). The study lists 6 primary outcomes in all. 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 21 Jan 2026.