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

November 20, 2023 updated by: Oasi Research Institute-IRCCS

DREAMER - IsolateD REM Sleep Without Atonia as a Risk Factor for REM Sleep Behavior disordER: Constitution of a Cohort for a Long-term Prospective Follow-up Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Rapid eye movement (REM) sleep behavior disorder (RBD) is a parasomnia characterized by dream-enactment behaviors that emerge during a loss of REM sleep atonia. RBD-related dream enactment ranges in severity from benign hand gestures to violent thrashing, punching, and kicking. In spontaneously occurring cases, RBD is a prodromal syndrome of alpha-synuclein neurodegeneration. Thus, the vast majority of RBD patients will eventually demonstrate signs and symptoms of Parkinson disease (PD) or a related disorder (e.g., multiple system atrophy or dementia with Lewy bodies), often after a prolonged interval. REM sleep without atonia (RSWA) is the hallmark of RBD and a required criterion of its diagnosis, in agreement with the International Classification of Sleep Disorders-3rd revision; however, RSWA has been reported also in subjects without RBD, as an 'incidental' finding or as an effect of antidepressants. There is preliminary observational evidence that this "isolated" RSWA might indicate an increased risk for the future development of RBD, and its occurrence with antidepressants has been interpreted as a possible indication of an acceleration of a possible underlying neurodegeneration. The scientific community is actively seeking for effective neuroprotective agents, and the very early identification of subjects at risk, years or even decades before the occurrence of a clear neurodegeneration is crucially important. The cohort constituted with this study will be able to provide extremely useful answers to this problem.

With the exception of Unit 1, which will be in charge of the implementation of the web-based electronic Clinical Report Form for the storage of data collected by all Units, the clinical work-up of all Units will be harmonized during the first 6 months of the project in order to collect, for all subjects recruited, after obtaining their informed consent, a common core of clinical and instrumental features. Unit 1 will also be in charge of the Ethics Committee procedure for the approval of the protocol, which will be accomplished during the first 3 months of activity. Particular attention will be paid to the privacy and data protection aspects of the project by involving the experts with the appropriate competences available for the activities of Unit 1 at the Oasi Research Institute (Data Protection Officer and information technology expert, in particular). Beside the definition of the inclusion/exclusion criteria and of the common core of data to collect, the recruitment of subjects will be carried-out in a period of at least 18 months by all Units, which are equipped with all necessary tools for the recording, scoring and storage of polysomnography (PSG) exams. PSG exams will be used for the identification of subjects with RSWA by means of the computation of the REM atonia index (RAI). In addition to the PSG recording, which will be performed in all subjects recruited, and in agreement with previous preliminary data produced by our groups on the possible detection of early subtle changes by means of other neurophysiological parameters , Unit 1 will also perform a transcranial magnetic stimulation (TMS) study for the evaluation of the cortical excitability of subjects found having RSWA and in an adequate group of subjects without RSWA. Similarly, Unit 2 will perform a complete Vestibular Evoked Myogenic Potentials (VEMPs) study of subjects found having RSWA and in an adequate group of subjects without RSWA, whereas Units 3 and 4 will ensure the recording of the Brainstem Auditory Evoked Potentials (BAEPs), which both evaluate the brainstem functioning. Additional instrumental exams, such as brain imaging (magnetic resonance imaging/computerized tomography scan), dopamine transporter (DAT) scan, etc., will be performed on the basis of the clinical needs of the subjects, as a part of their clinical diagnostic work-up. Finally, whenever possible and especially for subjects with RSWA, blood samples will be adequately stored for a final proteomic and metabolomic analysis in order to establish if omics signatures are expressed in them similar to those that we have already found in RBD patients .

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all participants undergoing full-night laboratory sleep PSG recording

Description

Inclusion Criteria:

  • age ≥18 years
  • sharing bedroom with a partner or roommate
  • absence of a severe health, neurological, or cognitive problem that would impair the comprehension of the study tasks
  • sleep recording without important artifact in the chin electromyographic signals, and presence of at least 5 min of REM sleep.

Exclusion Criteria:

  • previous diagnosis of RBD,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment of 600 subjects without and with RSWA.
Time Frame: 18 months
Constitution of a large cohort of 600 subjects without and with RSWA.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oasi Research Institute-IRCCS

Collaborators

IRCCS San Raffaele
University of Cagliari, Cagliari, Italy
IRCCS- Institute of Neurological Sciences, Bologna, Italy

Investigators

  • Principal Investigator: Raffaele Ferri, MD, Oasi Research Institute-IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 20, 2023

Primary Completion (Estimated)

May 19, 2025

Study Completion (Estimated)

May 19, 2025

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 20, 2023

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNRR MR1 2022-12375694 (Other Grant/Funding Number: Italian Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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