REM Sleep Behavior DisorderSEV-TCSPNCT04071899
French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP)
An observational study of REM Sleep Behavior Disorder, run by University Hospital, Clermont-Ferrand at 5 sites in France.
Trial summary
REM (Rapid Eye Movements) Sleep Behavior Disorder (RBD) is a parasomnia characterized by episodes of elaborate or violent motor activity during dreams, which can lead to injury and sleep disruption in patient and / or his/her spouse. This is due to the loss of the normal muscle atonia during REM Sleep. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- REM Sleep Behavior Disorder
- What is being tested?
- Scale vaidation
- How many people
- 80 participants
- Where
- 5 sitesFrance
- Study dates
- 24 May 2019to 24 Sep 2020
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with RBD and their bedpartner
Who may be able to join
- RBD patients:
- Men or women aged 30 to 80
- Patients with idiopathic and secondary RBD (including RBD associated with Parkinson's disease, Narcolepsy, Multiple System Atrophy or other neurological diseases) diagnosed according to the latest international criteria Classification of Sleep Disorders (ICSD-3 ).
- Cooperation and understanding to strictly comply with the conditions laid down in the protocol
- Affiliated to a social security system
- bedpartners
Show all 10Show fewer
- Men or women aged 30 to 80
- Subjects sharing the same bed as the patient for ≥70% of the time (e.g. at least 5 nights / week, or 20 nights / month)
- -Cooperation and understanding to strictly comply with the conditions described in the protocol
- Affiliated to a social security system
Who cannot join
- -- RBD patients:
- Clinically defined dementia according to the criteria of DSM-V2 (Major Neurocognitive Disorder)
- Untreated Obstructive Sleep Apnea Syndrome (OSAS) (with IAH> 15 / h at vPSG)
- Patients under tutorship or curatorship or safeguard of justice
- No change in treatment should have occurred during the 4 weeks prior to inclusion in the study and no change in treatment should be expected a priori within one week of inclusion
- Bedpartners
- Clinically defined dementia according to the criteria of DSM-V2 (Major Neurocognitive Disorder)
- Patients under tutorship or curatorship or safeguard of justice
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Maria Livia Fantini, +334.73751600, mfantini@chu-clermontferrand.fr
Maria Livia Fantini
- Recruiting
Hôpital de la Croix Rousse
Lyon, 69004
Laure PETER-DEREX, laure.peter-derex@chu-lyon.fr
Laure PETER-DEREX
- Recruiting
Clinique beausoleil
Montpellier, 34070
Valérie COCHEN DE COCK, valerie.cochen@gmail.com
Valérie COCHEN DE COCK
- Recruiting
CHU Nantes
Nantes, 44000
Laurène LECLAIR-VISONNEAU, Laurene.leclair@univ-nantes.fr
Laurène LECLAIR-VISONNEAU
- Recruiting
AP-HP
Paris, 75013
Isabelle Arnulf, isabelle.arnulf@aphp.fr
Isabelle Arnulf
About this study
Official title: French Validation of a Severity Scale in REM Sleep Behavior Disorder
REM (Rapid Eye Movements) Sleep Behavior Disorder (RBD) is a parasomnia characterized by episodes of elaborate or violent motor activity during dreams, which can lead to injury and sleep disruption in patient and / or his/her spouse. This is due to the loss of the normal muscle atonia during REM Sleep. RBD is often associated to neurodegenerative diseases, and may even precede them for several years as an early marker. Currently, there is no scale or tool for assessing the severity of RBD. Nevertheless, it is crucial to have a tool of severity when one wants to study the natural evolution of this disorder, as well as the possible effect of a drug in the context of a clinical trial. A Severity Scale of RBD has recently been proposed within the International RBD Study Group and an international validation study in several languages is being considered.
The main objective of this study is to validate a new scale of severity of the REM sleep behavior disorder (RBD Severity Scale or RBDSS) and to characterize its metrological properties, in particular its concurrent validity, internal consistency and reproducibility
Read the detailed description
Research involving the human person, non-interventional, category 3
80 patients with RBD of any etiology (eg Idiopathic RBD, RBD associated with Parkinson's Disease, Multiple System Atrophy, Narcolepsy etc.) and their bedpartners (if available) will be include in 5 French centers (Clermont-Ferrand, Paris, Nantes, Montpellier et Lyon) Patients, and their bedpartners (if available), will be seen 2 times at 1 week intervals.
For the patients Visit 1 (Day 0): duration : 60 minutes
- Information to patient and collection of non-opposition
- Collection of socio-demographic data: age, sex, level of education
- Clinical data collection: duration of RBD, duration and severity of the concomitant disease:, medical and surgical history
- Assessment of cognitive functions: Mini Mental State Examination
- Verification of inclusion / exclusion criteria
- Ongoing treatments and calculation of Levodopa Equivalent Daily Dose (LEDD) for PD patients.
- RBD severity scale for Patient (RBDSS-PT) + Global Clinical Impression-Severity Scale
Visit 2 (J7) : duration : 20 minutes
- Ongoing treatments
- RBDSS PT + Global Clinical Impression-Severity Scale (CGI-S-PT)
- Patient will be given a Weekly Severity Agenda for 4 weeks plus a copy of the RBSSS-PT + Global Clinical Impression-Severity Scale
At home, patients will fill :
D8 à D36 :
- Weekly Severity Agenda (wRBDQ) for 4 weeks
D36 :
- RBDSS-PT + Clinical Global Impression-Severity These documents will be mailed back in a pre-payed envelop. For the Bed Partners Visit 1 (D0- baseline): duration: 30 minutes
- Information of and collection of non opposition
- Collection of socio-demographic data: age, sex, level of education
- Assessment of cognitive functions: Mini Mental State Examination
- Verification of inclusion / exclusion criteria
- Ongoing Treatments
- RBD severity scale of the bed partner (RBDSS BP)+ Global Clinical Impression-Severity Scale
Visit 2 (D7- retest) : duration : 20 minutes
- Ongoing treatments
- RBDSS-BP + Clinical Overall Impression Severity Scale
- Patient will be given a Weekly Joint Severity Agenda to be completed together with the patient, (wRBDQ) for 4 weeks, plus a copy of the RBDSS-BP + CGI-S-BP
At home: bedpartners will fill:
D8 à D36 :
- Weekly Severity Agenda for 4 weeks, in common with patient
D36 :
- RBDSS-BP + Impression Global Clinique-Severity scale These documents will be mailed back in a pre-payed envelop.
- Conditions
- REM Sleep Behavior Disorder
- Being tested
- Scale vaidation
- Keywords
- REM Sleep Behavior Disorder, Validation scale
- 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.
Scale vaidationOther
It's just filling a scale in order to validate it in French
| Study group | Role | What they receive |
|---|---|---|
| Patients | patients with RBD Receives: Other: Scale vaidation | |
| Bedpartners | Subjects which are the bedpartners of patients with RBD Receives: Other: Scale vaidation |
What is being measured
The primary outcome is the main question the study is designed to answer.
French validation of a new scale of severity of REM Sleep behavior disorder for patient
The scale contains 8 items in the patient version. Each of them focusing on one RBD symptom, are evaluated in terms of their frequency and severity. This scale was administered at Day7 to evaluate concurrent validity, internal consistency and reproducibility
Measured: Day 7
French validation of a new scale of severity of REM Sleep behavior disorder for patient
The scale contains 8 items in the patient version. Each of them focusing on one RBD symptom, are evaluated in terms of their frequency and severity. This scale was administered at Day 0 to evaluate concurrent validity, internal consistency and reproducibility
Measured: Day 0
Secondary outcomes (5)
French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners
The scale contains 6 items in the patient version. After two introductory questions that are not scored, the scale includes items concerning the spouse's RBD symptoms and are evaluated in terms of their frequency and severity. This scale was administered at Day 7 to to evaluate concurrent validity, internal consistency and reproducibility
Measured: Day 7
French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners
The scale contains 6 items in the patient version. After two introductory questions that are not scored, the scale includes items concerning the spouse's RBD symptoms and are evaluated in terms of their frequency and severity. This scale was administered at Day 0 to to evaluate concurrent validity, internal consistency and reproducibility
Measured: Day 0
Evaluation of the psychometric properties of the patient scale according to the etiology of the RBD
The total pool of patients will be divided into different groups according to the etiology (RBD-Idiopathic, RBD-parkinsons disease, RBD- Multiple System Atrophy, RBD-Narcolepsy etc.) and the validity in each condition will be evaluated
Measured: Day 7
Evaluation of the fluctuations in the frequency and severity of RBD symptoms and their "night-to-night" variability through the collection of daily data over a four-week period
In order to control variability of symptoms, patients and their bed partners will complete a Weekly Symptom Diary (weekly-RBD Questionnaire), measuring the frequency and severity of symptoms daily for 4 weeks to determine the fluctuation of symptoms over a long period
Measured: Day 28
Evaluation of the RBD severity using Clinical Global Impression-Severity
This scale is s the only currently available measure of severity of RBD. It includes 7 categories that are from 1 to 7: Normal (no symptoms), Minimal, Light, Moderate, Marked, Severe, Very Severe
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start24 May 2019
- Primary completion24 Jun 2020 (estimated)
- Study completion24 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française de Recherche et Médecine du Sommeil
- Responsible party
- Sponsor
- Investigators
- Maria-Livia Fantini, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071899
- Sponsor's protocol ID
- RNI 2018 FANTINI (SEV-TCSP)
- Other IDs
- 2018-A02473-52
- Acronym
- SEV-TCSP
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fantini ML, Postuma RB, Puligheddu M, Rieu I, Venel E, Figorilli M, Cochen-DeCock V, Leclair-Visonneau L, Arnaldi D, Mattioli P, Peter-Derex L, Ricordeau F, Terzaghi M, Arnulf I, Stefani A, Videnovic A, Chirol C, Pereira B; International RBD Study Group. Validation of the International REM Sleep Behavior Disorder Study Group Symptoms Severity Scale (IRBD-SSS): a new tool to assess RBD clinical severity. J Neurol. 2024 Nov;271(11):7264-7271. doi: 10.1007/s00415-024-12702-9. Epub 2024 Sep 27.
PubMed 39327269
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Validation of a Severity Scale in REM Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT04071899
- Acronym / sponsor ID
- SEV-TCSP / RNI 2018 FANTINI (SEV-TCSP)
- Conditions
- REM Sleep Behavior Disorder
- Keywords
- REM Sleep Behavior Disorder, Validation scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Société Française de Recherche et Médecine du Sommeil
- Study start
- 24 May 2019 (actual)
- Primary completion
- 24 Jun 2020 (estimated)
- Study completion
- 24 Sep 2020 (estimated)
- First posted
- 28 Aug 2019 (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.
REM (Rapid Eye Movements) Sleep Behavior Disorder (RBD) is a parasomnia characterized by episodes of elaborate or violent motor activity during dreams, which can lead to injury and sleep disruption in patient and / or his/her spouse. This is due to the loss of the normal muscle atonia during REM Sleep. RBD is often associated to neurodegenerative diseases, and may even precede them for several years as an early marker. Currently, there is no scale or tool for assessing the severity of RBD. Nevertheless, it is crucial to have a tool of severity when one wants to study the natural evolution of this disorder, as well as the possible effect of a drug in the context of a clinical trial. A Severity Scale of RBD has recently been proposed within the International RBD Study Group and an international validation study in several languages is being considered.
The main objective of this study is to validate a new scale of severity of the REM sleep behavior disorder (RBD Severity Scale or RBDSS) and to characterize its metrological properties, in particular its concurrent validity, internal consistency and reproducibility
Detailed description
Research involving the human person, non-interventional, category 3
80 patients with RBD of any etiology (eg Idiopathic RBD, RBD associated with Parkinson's Disease, Multiple System Atrophy, Narcolepsy etc.) and their bedpartners (if available) will be include in 5 French centers (Clermont-Ferrand, Paris, Nantes, Montpellier et Lyon) Patients, and their bedpartners (if available), will be seen 2 times at 1 week intervals.
For the patients Visit 1 (Day 0): duration : 60 minutes
- Information to patient and collection of non-opposition
- Collection of socio-demographic data: age, sex, level of education
- Clinical data collection: duration of RBD, duration and severity of the concomitant disease:, medical and surgical history
- Assessment of cognitive functions: Mini Mental State Examination
- Verification of inclusion / exclusion criteria
- Ongoing treatments and calculation of Levodopa Equivalent Daily Dose (LEDD) for PD patients.
- RBD severity scale for Patient (RBDSS-PT) + Global Clinical Impression-Severity Scale
Visit 2 (J7) : duration : 20 minutes
- Ongoing treatments
- RBDSS PT + Global Clinical Impression-Severity Scale (CGI-S-PT)
- Patient will be given a Weekly Severity Agenda for 4 weeks plus a copy of the RBSSS-PT + Global Clinical Impression-Severity Scale
At home, patients will fill :
D8 à D36 :
- Weekly Severity Agenda (wRBDQ) for 4 weeks
D36 :
- RBDSS-PT + Clinical Global Impression-Severity These documents will be mailed back in a pre-payed envelop. For the Bed Partners Visit 1 (D0- baseline): duration: 30 minutes
- Information of and collection of non opposition
- Collection of socio-demographic data: age, sex, level of education
- Assessment of cognitive functions: Mini Mental State Examination
- Verification of inclusion / exclusion criteria
- Ongoing Treatments
- RBD severity scale of the bed partner (RBDSS BP)+ Global Clinical Impression-Severity Scale
Visit 2 (D7- retest) : duration : 20 minutes
- Ongoing treatments
- RBDSS-BP + Clinical Overall Impression Severity Scale
- Patient will be given a Weekly Joint Severity Agenda to be completed together with the patient, (wRBDQ) for 4 weeks, plus a copy of the RBDSS-BP + CGI-S-BP
At home: bedpartners will fill:
D8 à D36 :
- Weekly Severity Agenda for 4 weeks, in common with patient
D36 :
- RBDSS-BP + Impression Global Clinique-Severity scale These documents will be mailed back in a pre-payed envelop.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Scale vaidationpatients with RBD |
| Bedpartners | – | Other: Scale vaidationSubjects which are the bedpartners of patients with RBD |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with RBD and their bedpartner
Key inclusion criteria (10 listed)
- RBD patients:
Key exclusion criteria (8 listed)
- Clinically defined dementia according to the criteria of DSM-V2 (Major Neurocognitive Disorder)
- Untreated Obstructive Sleep Apnea Syndrome (OSAS) (with IAH> 15 / h at vPSG)
- Patients under tutorship or curatorship or safeguard of justice
- No change in treatment should have occurred during the 4 weeks prior to inclusion in the study and no change in treatment should be expected a priori within one week of inclusion
- Bedpartners
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 |
|---|---|---|
| Scale vaidationIt's just filling a scale in order to validate it in French | Other | Bedpartners, Patients |
Primary outcome
French validation of a new scale of severity of REM Sleep behavior disorder for patient
Time frame: Day 7
The scale contains 8 items in the patient version. Each of them focusing on one RBD symptom, are evaluated in terms of their frequency and severity. This scale was administered at Day7 to evaluate concurrent validity, internal consistency and reproducibility
French validation of a new scale of severity of REM Sleep behavior disorder for patient
Time frame: Day 0
The scale contains 8 items in the patient version. Each of them focusing on one RBD symptom, are evaluated in terms of their frequency and severity. This scale was administered at Day 0 to evaluate concurrent validity, internal consistency and reproducibility
5 secondary outcomes
French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners
Time frame: Day 7
French validation of a new scale of severity of REM Sleep behavior disorder for bedpartners
Time frame: Day 0
Evaluation of the psychometric properties of the patient scale according to the etiology of the RBD
Time frame: Day 7
Evaluation of the fluctuations in the frequency and severity of RBD symptoms and their "night-to-night" variability through the collection of daily data over a four-week period
Time frame: Day 28
Evaluation of the RBD severity using Clinical Global Impression-Severity
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 39327269Fantini ML, Postuma RB, Puligheddu M, Rieu I, Venel E, Figorilli M, Cochen-DeCock V, Leclair-Visonneau L, Arnaldi D, Mattioli P, Peter-Derex L, Ricordeau F, Terzaghi M, Arnulf I, Stefani A, Videnovic A, Chirol C, Pereira B; International RBD Study Group. Validation of the International REM Sleep Behavior Disorder Study Group Symptoms Severity Scale (IRBD-SSS): a new tool to assess RBD clinical severity. J Neurol. 2024 Nov;271(11):7264-7271. doi: 10.1007/s00415-024-12702-9. Epub 2024 Sep 27.
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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.
Maria-Livia Fantini principal investigator
University Hospital, Clermont-Ferrand
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of REM Sleep Behavior Disorder, run by University Hospital, Clermont-Ferrand at 5 sites in France.
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 10 inclusion and 8 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Lise Laclautre (+334.73.751.195, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
French validation of a new scale of severity of REM Sleep behavior disorder for patient (time frame: Day 7). The study lists 2 primary outcomes in all. 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 NCT04071899, which also lists 1 linked publication.
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 28 Aug 2019.