REM Sleep Behavior DisorderDREAMERNCT06140511
DREAMER - IsolateD REM Sleep Without Atonia as a Risk Factor for REM Sleep Behavior disordER
An observational study of REM Sleep Behavior Disorder, run by Oasi Research Institute-IRCCS.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- REM Sleep Behavior Disorder
- What is being tested?
- Polysomnography
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2023to 19 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all participants undergoing full-night laboratory sleep PSG recording
Who may be able to join
- 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.
Who cannot join
- previous diagnosis of RBD,
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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 .
- Conditions
- REM Sleep Behavior Disorder
- Being tested
- Polysomnography
- Medical subject headings
- REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment of 600 subjects without and with RSWA.
Constitution of a large cohort of 600 subjects without and with RSWA.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start20 Nov 2023 (estimated)
- Primary completion19 May 2025 (estimated)
- Study completion19 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oasi Research Institute-IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cagliari, IRCCS Istituto delle Scienze Neurologiche di Bologna, IRCCS San Raffaele
- Responsible party
- Sponsor
- Investigators
- Raffaele Ferri, MD, Principal investigator, Oasi Research Institute-IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140511
- Sponsor's protocol ID
- PNRR MR1 2022-12375694
- Other IDs
- PNRR MR1 2022-12375694
- Acronym
- DREAMER
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dong X, Mondello S, Kobeissy F, Talih F, Ferri R, Mechref Y. LC-MS/MS glycomics of idiopathic rapid eye movement sleep behavior disorder. Electrophoresis. 2018 Dec;39(24):3096-3103. doi: 10.1002/elps.201800316. Epub 2018 Sep 12.
PubMed 30168606Dijkstra F, Viaene M, Crosiers D, De Volder I, Cras P. Frequency and characteristic features of REM sleep without atonia. Clin Neurophysiol. 2019 Oct;130(10):1825-1832. doi: 10.1016/j.clinph.2019.07.018. Epub 2019 Jul 27.
PubMed 31401491Ferri R, Manconi M, Plazzi G, Bruni O, Vandi S, Montagna P, Ferini-Strambi L, Zucconi M. A quantitative statistical analysis of the submentalis muscle EMG amplitude during sleep in normal controls and patients with REM sleep behavior disorder. J Sleep Res. 2008 Mar;17(1):89-100. doi: 10.1111/j.1365-2869.2008.00631.x.
PubMed 18275559Ferri R, Rundo F, Manconi M, Plazzi G, Bruni O, Oldani A, Ferini-Strambi L, Zucconi M. Improved computation of the atonia index in normal controls and patients with REM sleep behavior disorder. Sleep Med. 2010 Oct;11(9):947-9. doi: 10.1016/j.sleep.2010.06.003.
PubMed 20817596Ferri R, Bruni O, Fulda S, Zucconi M, Plazzi G. A quantitative analysis of the submentalis muscle electromyographic amplitude during rapid eye movement sleep across the lifespan. J Sleep Res. 2012 Jun;21(3):257-63. doi: 10.1111/j.1365-2869.2011.00958.x. Epub 2011 Sep 28.
PubMed 21955170Ferri R, Fulda S, Cosentino FI, Pizza F, Plazzi G. A preliminary quantitative analysis of REM sleep chin EMG in Parkinson's disease with or without REM sleep behavior disorder. Sleep Med. 2012 Jun;13(6):707-13. doi: 10.1016/j.sleep.2012.01.003. Epub 2012 Mar 20.
PubMed 22440085Ferri R, Arico D, Cosentino FII, Lanuzza B, Chiaro G, Manconi M. REM sleep without atonia with REM sleep-related motor events: broadening the spectrum of REM sleep behavior disorder. Sleep. 2018 Dec 1;41(12). doi: 10.1093/sleep/zsy187.
PubMed 30239958Ferri R, Mogavero MP, Bruni O, Plazzi G, Schenck CH, DelRosso LM. Increased chin muscle tone during all sleep stages in children taking selective serotonin reuptake inhibitor antidepressants and in children with narcolepsy type 1. Sleep. 2021 Nov 12;44(11):zsab147. doi: 10.1093/sleep/zsab147.
PubMed 34111296Figorilli M, Lanza G, Congiu P, Lecca R, Casaglia E, Mogavero MP, Puligheddu M, Ferri R. Neurophysiological Aspects of REM Sleep Behavior Disorder (RBD): A Narrative Review. Brain Sci. 2021 Nov 30;11(12):1588. doi: 10.3390/brainsci11121588.
PubMed 34942893Lanza G, Cosentino FII, Lanuzza B, Tripodi M, Arico D, Figorilli M, Puligheddu M, Fisicaro F, Bella R, Ferri R, Pennisi M. Reduced Intracortical Facilitation to TMS in Both Isolated REM Sleep Behavior Disorder (RBD) and Early Parkinson's Disease with RBD. J Clin Med. 2022 Apr 20;11(9):2291. doi: 10.3390/jcm11092291.
PubMed 35566417Lanza G, Arico D, Lanuzza B, Cosentino FII, Tripodi M, Giardina F, Bella R, Puligheddu M, Pennisi G, Ferri R, Pennisi M. Facilitatory/inhibitory intracortical imbalance in REM sleep behavior disorder: early electrophysiological marker of neurodegeneration? Sleep. 2020 Mar 12;43(3):zsz242. doi: 10.1093/sleep/zsz242.
PubMed 31599326Lee K, Baron K, Soca R, Attarian H. The Prevalence and Characteristics of REM Sleep without Atonia (RSWA) in Patients Taking Antidepressants. J Clin Sleep Med. 2016 Mar;12(3):351-5. doi: 10.5664/jcsm.5582.
PubMed 26446247Miyamoto M, Miyamoto T, Kubo J, Yokota N, Hirata K, Sato T. Brainstem function in rapid eye movement sleep behavior disorder: the evaluation of brainstem function by proton MR spectroscopy (1H-MRS). Psychiatry Clin Neurosci. 2000 Jun;54(3):350-1. doi: 10.1046/j.1440-1819.2000.00710.x.
PubMed 11186109Mondello S, Kobeissy F, Mechref Y, Zhao J, Talih FR, Cosentino F, Antelmi E, Moresco M, Plazzi G, Ferri R. Novel biomarker signatures for idiopathic REM sleep behavior disorder: A proteomic and system biology approach. Neurology. 2018 Oct 30;91(18):e1710-e1715. doi: 10.1212/WNL.0000000000006439. Epub 2018 Sep 26.
PubMed 30258025Postuma RB, Iranzo A, Hu M, Hogl B, Boeve BF, Manni R, Oertel WH, Arnulf I, Ferini-Strambi L, Puligheddu M, Antelmi E, Cochen De Cock V, Arnaldi D, Mollenhauer B, Videnovic A, Sonka K, Jung KY, Kunz D, Dauvilliers Y, Provini F, Lewis SJ, Buskova J, Pavlova M, Heidbreder A, Montplaisir JY, Santamaria J, Barber TR, Stefani A, St Louis EK, Terzaghi M, Janzen A, Leu-Semenescu S, Plazzi G, Nobili F, Sixel-Doering F, Dusek P, Bes F, Cortelli P, Ehgoetz Martens K, Gagnon JF, Gaig C, Zucconi M, Trenkwalder C, Gan-Or Z, Lo C, Rolinski M, Mahlknecht P, Holzknecht E, Boeve AR, Teigen LN, Toscano G, Mayer G, Morbelli S, Dawson B, Pelletier A. Risk and predictors of dementia and parkinsonism in idiopathic REM sleep behaviour disorder: a multicentre study. Brain. 2019 Mar 1;142(3):744-759. doi: 10.1093/brain/awz030.
PubMed 30789229
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06140511
- Acronym / sponsor ID
- DREAMER / PNRR MR1 2022-12375694
- Conditions
- REM Sleep Behavior Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Oasi Research Institute-IRCCSUniversity, hospital or other
- Collaborators
- University of Cagliari, IRCCS Istituto delle Scienze Neurologiche di Bologna, IRCCS San Raffaele
- Study start
- 20 Nov 2023 (estimated)
- Primary completion
- 19 May 2025 (estimated)
- Study completion
- 19 May 2025 (estimated)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all participants undergoing full-night laboratory sleep PSG recording
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- previous diagnosis of RBD,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyPolysomnography 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. | Diagnostic test | – |
Primary outcome
Enrollment of 600 subjects without and with RSWA.
Time frame: 18 months
Constitution of a large cohort of 600 subjects without and with RSWA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 30168606Dong X, Mondello S, Kobeissy F, Talih F, Ferri R, Mechref Y. LC-MS/MS glycomics of idiopathic rapid eye movement sleep behavior disorder. Electrophoresis. 2018 Dec;39(24):3096-3103. doi: 10.1002/elps.201800316. Epub 2018 Sep 12.
- Background: PubMed 31401491Dijkstra F, Viaene M, Crosiers D, De Volder I, Cras P. Frequency and characteristic features of REM sleep without atonia. Clin Neurophysiol. 2019 Oct;130(10):1825-1832. doi: 10.1016/j.clinph.2019.07.018. Epub 2019 Jul 27.
- Background: PubMed 18275559Ferri R, Manconi M, Plazzi G, Bruni O, Vandi S, Montagna P, Ferini-Strambi L, Zucconi M. A quantitative statistical analysis of the submentalis muscle EMG amplitude during sleep in normal controls and patients with REM sleep behavior disorder. J Sleep Res. 2008 Mar;17(1):89-100. doi: 10.1111/j.1365-2869.2008.00631.x.
- Background: PubMed 20817596Ferri R, Rundo F, Manconi M, Plazzi G, Bruni O, Oldani A, Ferini-Strambi L, Zucconi M. Improved computation of the atonia index in normal controls and patients with REM sleep behavior disorder. Sleep Med. 2010 Oct;11(9):947-9. doi: 10.1016/j.sleep.2010.06.003.
- Background: PubMed 21955170Ferri R, Bruni O, Fulda S, Zucconi M, Plazzi G. A quantitative analysis of the submentalis muscle electromyographic amplitude during rapid eye movement sleep across the lifespan. J Sleep Res. 2012 Jun;21(3):257-63. doi: 10.1111/j.1365-2869.2011.00958.x. Epub 2011 Sep 28.
- Background: PubMed 22440085Ferri R, Fulda S, Cosentino FI, Pizza F, Plazzi G. A preliminary quantitative analysis of REM sleep chin EMG in Parkinson's disease with or without REM sleep behavior disorder. Sleep Med. 2012 Jun;13(6):707-13. doi: 10.1016/j.sleep.2012.01.003. Epub 2012 Mar 20.
- Background: PubMed 30239958Ferri R, Arico D, Cosentino FII, Lanuzza B, Chiaro G, Manconi M. REM sleep without atonia with REM sleep-related motor events: broadening the spectrum of REM sleep behavior disorder. Sleep. 2018 Dec 1;41(12). doi: 10.1093/sleep/zsy187.
- Background: PubMed 34111296Ferri R, Mogavero MP, Bruni O, Plazzi G, Schenck CH, DelRosso LM. Increased chin muscle tone during all sleep stages in children taking selective serotonin reuptake inhibitor antidepressants and in children with narcolepsy type 1. Sleep. 2021 Nov 12;44(11):zsab147. doi: 10.1093/sleep/zsab147.
- Background: PubMed 34942893Figorilli M, Lanza G, Congiu P, Lecca R, Casaglia E, Mogavero MP, Puligheddu M, Ferri R. Neurophysiological Aspects of REM Sleep Behavior Disorder (RBD): A Narrative Review. Brain Sci. 2021 Nov 30;11(12):1588. doi: 10.3390/brainsci11121588.
- Background: PubMed 35566417Lanza G, Cosentino FII, Lanuzza B, Tripodi M, Arico D, Figorilli M, Puligheddu M, Fisicaro F, Bella R, Ferri R, Pennisi M. Reduced Intracortical Facilitation to TMS in Both Isolated REM Sleep Behavior Disorder (RBD) and Early Parkinson's Disease with RBD. J Clin Med. 2022 Apr 20;11(9):2291. doi: 10.3390/jcm11092291.
- Background: PubMed 31599326Lanza G, Arico D, Lanuzza B, Cosentino FII, Tripodi M, Giardina F, Bella R, Puligheddu M, Pennisi G, Ferri R, Pennisi M. Facilitatory/inhibitory intracortical imbalance in REM sleep behavior disorder: early electrophysiological marker of neurodegeneration? Sleep. 2020 Mar 12;43(3):zsz242. doi: 10.1093/sleep/zsz242.
- Background: PubMed 26446247Lee K, Baron K, Soca R, Attarian H. The Prevalence and Characteristics of REM Sleep without Atonia (RSWA) in Patients Taking Antidepressants. J Clin Sleep Med. 2016 Mar;12(3):351-5. doi: 10.5664/jcsm.5582.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Ferri, MD principal investigator
Oasi Research Institute-IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of REM Sleep Behavior Disorder, run by Oasi Research Institute-IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Mercadante, PhD (+39 0935 936913, lmercadante@oasi.en.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment of 600 subjects without and with RSWA. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06140511, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.