NCT05976971 (SODISLEEP) is a NA clinical trial of 7T MRI in REM Sleep Behaviour Disorder, sponsored by Assistance Publique Hopitaux De Marseille.

Who is sponsoring NCT05976971?

NCT05976971 is sponsored by Assistance Publique Hopitaux De Marseille.

What drugs are being tested in NCT05976971?

Interventions in NCT05976971: 7T MRI.

What condition does NCT05976971 study?

NCT05976971 studies REM Sleep Behaviour Disorder.

Is NCT05976971 still recruiting?

NCT05976971 is currently completed. Last updated 21 January 2026.

Last reviewed 2026-01-21 · How we verify

NCT05976971: SODISLEEP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Microstructural and Sodium 7 Tesla Brain MRI in Idiopathic REM Sleep Behaviour Disorder

Completed NA Last updated 21 January 2026

What this trial tests

NA trial testing 7T MRI in REM Sleep Behaviour Disorder in 31 participants. Completed in 9 December 2025.

Timeline

30 October 2023

Primary endpoint
9 December 2025

9 December 2025

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	31
Start date	30 October 2023
Primary completion	9 December 2025
Estimated completion	9 December 2025
Sites	1 location across France

Drugs / interventions tested

7T MRI

Conditions studied

REM Sleep Behaviour Disorder — all drugs for REM Sleep Behaviour Disorder →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

Adults 40 to 80, any sex, with REM Sleep Behaviour Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of 7T MRI

Trials testing the same drug.

NCT07245589 — Evaluation of the Clinical Contribution of Quantitative MRI in Neuro-imaging · NA · not yet recruiting
NCT05967832 — Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy · NA · unknown
NCT07118137 — Memory Deterioration in Alzheimer Disease · recruiting
NCT04982562 — Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injur · NA · unknown
NCT03243721 — Gilenya's Impact on Cognitive Function and Thalamic Volumes · NA · completed

Other Assistance Publique Hopitaux De Marseille trials

Trials by the same sponsor.

NCT07521644 — Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome · NA · not yet recruiting
NCT07357025 — Resting-State fMRI Study of Functional Connectivity After Gamma Knife Radiosurgery in Trigeminal Neuralgia · NA · not yet recruiting
NCT07356661 — Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Epileptic Patients · NA · not yet recruiting
NCT07399327 — Biomarkers of Response to SEEG Thermocoagulation · NA · not yet recruiting
NCT06999499 — Development of an Aid to Melanoma Detection Using Artificial Intelligence Algorithms Based on Images From the VECTRA 3D · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05976971 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille
Last refreshed: 21 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05976971.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing