Identifying risk factors for REM Sleep Behavior Disorder
Redictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study [FAttori di Rischio PREdittivi di Conversione Nell'RBD Idiopatico. STudio ItalianO
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 type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cagliari Academic / other |
| Locations | 2 sites (Oggebbio, Verbania and 1 other locations) |
| Trial ID | NCT05262543 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with idiopathic REM Sleep Behavior Disorder.
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.
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 performed: While the exact approach may be novel, similar studies have indicated the importance of identifying risk factors in sleep disorders, suggesting potential for success.
Eligibility criteria
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 this trial is running
Oggebbio, Verbania and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.