Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Identifying risk factors for REM Sleep Behavior Disorder

Official title: Redictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study [FAttori di Rischio PREdittivi di Conversione Nell'RBD Idiopatico. STudio ItalianO

Run by University of Cagliari · NCT05262543 · Data updated 2026-11-12

This study is trying to find out what factors might lead to people developing REM Sleep Behavior Disorder by looking at their sleep patterns and movements during sleep.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorUniversity of Cagliari
Academic / other
Locations2 sites (Oggebbio, Verbania and 1 other locations)
StatusRecruiting
StartedMay 25, 2020
Main results expectedMarch 31, 2025
Study endsJanuary 31, 2035
Registry record updatedMarch 26, 2024
Trial IDNCT05262543 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old diagnosed with idiopathic REM Sleep Behavior Disorder.

Probably not a fit

Patients who are unable to provide informed consent or have conditions that prevent them from participating in the study may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify predictive risk factors for the conversion into idiopathic REM Sleep Behavior Disorder (iRBD). Participants diagnosed with iRBD will undergo video-polysomnographic recording to assess the loss of muscle atonia during REM sleep and related motor behaviors. The study seeks to better understand the prevalence and characteristics of RBD, which is often underdiagnosed. By analyzing data from multiple Italian universities, the research will contribute to the understanding of this sleep disorder.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and management of REM Sleep Behavior Disorder, enhancing patient quality of life.

How similar studies have gone: While the exact approach may be novel, similar studies have indicated the importance of identifying risk factors in sleep disorders, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age: major of 18 years old
* iRBD diagnosis, according to diagnostic criteria of the ICSD second and third edition

Exclusion Criteria:

* Impossibility to provide or withdraw informed consent and inability to read, write and understand the purpose and modality of the study.

Where it's running

  • IRCCS Auxologico Piancavallo
    Oggebbio, Verbania, Italy
    Recruiting
  • Centro Interdipartimentale di Medicina del Sonno, Università degli studi di Cagliari
    Cagliari, Italy
    Recruiting

Study contacts

  • Principal investigator: Monica Puligheddu, MD,PhD — University of Cagliari
  • Study coordinator: Monica Puligheddu, MD, PhD
  • Email: centrosonnoca@unica.it
  • Phone: 070 5109 6016

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.