Evidence mapPaperPMID 42335119Full record

Observational studyPloS one2026

Protocol for the DREAMER study: Design and methodological framework of a multicenter trial-ready cohort of individuals with isolated REM sleep without atonia.

Raffaele Ferri, Monica Puligheddu, Michela Figorilli, Giuseppe Plazzi, Fabio Pizza, Luigi Ferini-Strambi, Sara Marelli, Giuseppe Lanza

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06140511 (DREAMER - IsolateD REM Sleep Without Atonia as a Risk Factor for REM Sleep Behavior disordER), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06140511 unknown statusnot on this map

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

TypeobservationalSponsorOasi Research Institute-IRCCSRan2023 to 2025Enrolled600ConditionsREM Sleep Behavior DisorderArmsPolysomnography
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Raffaele FerriSleep Research Centre and Clinical Neurophysiology Research Unit, Oasi Research Institute-IRCCS, Troina, Italy.ORCID https://orcid.org/0000-0001-6937-3065
Monica PulighedduSleep Disorder Center, Department of Public Health and Clinical and Molecular Medicine, University of Cagliari, Cagliari, Italy.
Michela FigorilliSleep Disorder Center, Department of Public Health and Clinical and Molecular Medicine, University of Cagliari, Cagliari, Italy.
Giuseppe PlazziIRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Fabio PizzaIRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Luigi Ferini-StrambiVita-Salute San Raffaele University, Milan, Italy.
Sara MarelliVita-Salute San Raffaele University, Milan, Italy.
Giuseppe LanzaSleep Research Centre and Clinical Neurophysiology Research Unit, Oasi Research Institute-IRCCS, Troina, Italy.ORCID https://orcid.org/0000-0002-5659-662X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Isolated rapid eye movement sleep behavior disorder is a strong clinical marker of future alpha-synucleinopathy, but earlier stages of this risk pathway remain insufficiently characterized. Rapid eye movement sleep without atonia is the polysomnographic substrate of this disorder and may also be detected in individuals without clinical dream-enactment behavior. Whether isolated rapid eye movement sleep without atonia is a benign finding or an early risk state for future rapid eye movement sleep behavior disorder and neurodegeneration remains unknown. DREAMER is a multicenter, prospective, observational cohort protocol designed to identify adults without clinical rapid eye movement sleep behavior disorder who show isolated rapid eye movement sleep without atonia during full-night laboratory video-polysomnography. Four Italian sleep centers will use harmonized eligibility criteria, standardized clinical and sleep assessment, quantitative REM Atonia Index scoring, secure web-based data capture, and planned longitudinal follow-up. Adults aged 40 years or older undergoing video-polysomnography will be screened. Participants with prior rapid eye movement sleep behavior disorder or technically inadequate REM sleep/chin electromyographic data will be excluded. Isolated rapid eye movement sleep without atonia will be defined in participants without clinical rapid eye movement sleep behavior disorder using a REM Atonia Index threshold of <0.85. The target recruitment is more than 500 participants over 18 months, with an expected enriched subgroup of approximately 85 individuals with isolated rapid eye movement sleep without atonia. Ancillary neurophysiological assessments and blood sampling for future biomarker studies will be obtained when feasible. DREAMER is intended to create a harmonized, trial-ready cohort for evaluating isolated rapid eye movement sleep without atonia as a potential early risk marker for incident rapid eye movement sleep behavior disorder and subsequent neurodegenerative outcomes. The study is registered at ClinicalTrials.gov as DREAMER, ClinicalTrials.gov Identifier NCT06140511.

Indexed as

DreamsREM Sleep Behavior DisorderSleep, REMAdultCohort StudiesElectromyographyFemaleHumansMaleMiddle AgedPolysomnographyProspective StudiesResearch Design

Identifiers

PMID42335119
PMCPMC13289868

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.