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DREAMER - IsolateD REM Sleep Without Atonia as a Risk Factor for REM Sleep Behavior disordER

NCT06140511 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-11-22

No results posted yet for this study

Summary

This study aims at the constitution of a large cohort of adult subjects without Rapid eye movement (REM) sleep behavior disorder (RBD), among whom subjects with isolated REM sleep without atonia (RSWA) will be identified; their long-term follow-up, compared to subjects without RSWA, will be useful in the next years to understand if this condition represents a risk factor for the future development of RBD, a condition in which the development of a neurodegenerative disorder (especially synucleinopathy) is highly probable. This will allow to obtain a wide time window for the establishment of prevention and neuroprotection in these subjects, with the goal to avoid or delay the development of the RBD\>synucleinopathy sequence. All Units will recruit a large number of subjects without RBD undergoing a polysomnography (PSG) recording, with a shared protocol, and the data collected will be stored on a web-based common database. Subjects showing RSWA in their PSG will be identified and used as a prospective study group, which will start at the end of the recruitment of this project.

Conditions

  • REM Sleep Behavior Disorder

Interventions

DIAGNOSTIC_TEST

Polysomnography

Polysomnography for the assessment of the presence of REM sleep without atonia (RSWA). All Units will recruit subjects to be included in the cohort and this will ensure the inclusion of a sufficiently large sample of subjects without and, especially, with RSWA. From a previous study \[Ferri et al. Sleep 2018:zsy187\] that we carried out on a similar group of subjects, we know that we can expect to find RSWA in approximately 14% of individuals.

Sponsors & Collaborators

  • University of Cagliari, Cagliari, Italy

    collaborator UNKNOWN

  • IRCCS- Institute of Neurological Sciences, Bologna, Italy

    collaborator UNKNOWN

  • IRCCS San Raffaele

    collaborator OTHER

  • Oasi Research Institute-IRCCS

    lead OTHER

Principal Investigators

  • Raffaele Ferri, MD · Oasi Research Institute-IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2025-05-19
Completion
2025-05-19

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06140511 on ClinicalTrials.gov