- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03047408
Evolution of RBD in PD
Evolution of REM Sleep Behavior Disorder in Parkinson's Disease Patients RBD Diagnosed Three Years Earlier
About 60% of Parkinson's Disease (PD) patients have REM sleep Behavior Disorder (RBD), a parasomnia characterized by partial or complete loss of REM sleep muscle atonia and dream-enacting behaviors, usually associated to vivid dreams. The REM Sleep without atonia is the polysomnographic hallmark of RBD, and its quantification is necessary for the diagnosis.
RBD in PD is believed to be a marker of a more widespread degenerative process and a marker of malignant phenotype. Therefore, PD patients with RBD (PD-RBD) are more severely impaired in both motor and non-motor domains, compared to those without RBD, with an increased risk of dementia. However, little is know about the relationship between the evolution of RBD, clinic and video-polysomnographic, and the progression of PD. Besides, an improvement of RBD symptoms is anecdotally reported in PD patients over time. Longitudinal evaluation of RBD in PD, assessed by questionnaires, led to controversial results, but so far, no longitudinal vPSG study has been performed in PD-RBD population.
Thus, the main objective of this study is to longitudinally evaluate clinical and video-polysomnographic features of RBD, including measure of REM Sleep without atonia, in patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain whether RBD features remain stable over time. The possible remission of RBD with the progression of PD would question indeed its reliability as prognostic bio-marker.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Type of study: longitudinal study, interventional, cross-sectional;
Number of centres: 1 (Clermont-Ferrand)
Patients: patients with Parkinson's Disease associated with REM sleep behavior disorder (PD-RBD) having already underwent video-polysomnography recording, clinical and neuropsychological evaluation in clinical setting or in the study "RBHP 2013 DURIF " at least three years ago.
Study performance:
This study will be developed in two phases:
- Phase 1 (Day 0):
- Verify inclusion criteria, receive informed and written consent;
- Demographic and clinical characteristics;
- Neurological evaluation: RBD (RBD severity scale), motor symptoms (Unified Parkinson's Disease Rating Scale, Hoeh et Yahr scale), orthostatic hypotension (Scale for outcomes in PD autonomic questionnaire), behavioral disorders hyper-dopaminergic and hypo-dopaminergic (Ardouin Scale of Behavior in Parkinson's Disease), impulsivity (Test Kirby and Stop signal reaction time)
- Dreams contents: all patients will receive 3-weeks dream diary;
- vPSG recording;
- Self-assessment questionnaires: Non-motor symptoms Questionnaire, Epworth sleepiness scale, Urgency premeditation perseverance and sensation seeking test, Aggressive questionnaire, and the Hospital Anxiety and Depression Rating Scale
- Phase 2 (+1day): Neuropsychological assessment of:
- Cognitive function, namely executive functions, visuo-spatial functions, visuo-perceptive functions (Mini mental state examination, California Verbal Learning Test, verbal fluency test, Modified Wisconsin Card Sorting Test, test de Stroop, Digit span, Visual Object and Space Perception Battery, Luria motor sequences, Rey-Osterrieth complex figure)
- Limbic functions: emotion recognition (Ekman test), apathy (Lille Apathy Rating Scale);
- Impulsivity and decision-making (Iowa Gambling test).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with clinically confirmed idiopathic Parkinson's Disease, according to the United Kingdom Parkinson Disease Bran Bank criteria, associated with RBD, diagnosed according to the International Classification of Sleep Disorders third edition, that have been already enrolled in the study "RBHP 2013 DURIF", or that have already underwent vPSG recording,clinical and neuropsychiatric evaluation in clinical setting;
- Male and female aged between 45 to 85 years old;
- All patients are volunteers and have given written informed consent;
- All patients are able to understand and to perform all tests included in this protocol;
- User-friendly in French language, both oral and written
Exclusion Criteria:
- Patients with neurological diseases other than PD;
- Patients with psychiatric comorbidities (hallucinations, psychosis) according to the DSM-5.
- Patients with Obstructive Sleep Apnea Syndrome (Apnea/hypopnea index >15/h);
- Patients in guardianship or tutorship;
- Patients enrolled exclusively in another study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients with PD-RBD
patients with PD-RBD having already underwent vPSG, clinical and neuropsychological in clinical setting or in the study "RBHP 2013 DURIF " at least three years ago.
|
the main objective of our study is to longitudinally evaluate clinical and vPSG features of RBD, including measure of RSWA, in patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain whether RBD features remain stable over time.
The possible remission of RBD with the progression of PD would question indeed its reliability as prognostic bio-marker.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
presence of REM sleep Behavior Disorder confirmed during the video polysomnography
Time Frame: at day 0
|
at day 0
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The REM sleep Behavior Disorder severity measured by the REM sleep Behavior Disorder scale
Time Frame: at day 0
|
at day 0
|
The Unified Parkinson disease Rating scale score
Time Frame: at day 0
|
at day 0
|
The behavioral disorders measured by the Ardouin Scale of Behavior in Parkinson's Disease score
Time Frame: at day 0
|
at day 0
|
- The Orthostatic hypotension measured by the Scale for outcomes in PD- autonomic questionnaire
Time Frame: at day 0
|
at day 0
|
The impulsivity measured by the Test of Kirby score
Time Frame: at day 0
|
at day 0
|
The impulsivity measured by the Stop signal reaction time score
Time Frame: at day 0
|
at day 0
|
The Hoehn and Yahr scale score
Time Frame: at day 0
|
at day 0
|
The Non-motor symptoms Questionnaire score
Time Frame: at day 0
|
at day 0
|
The Epworth sleepiness scale score
Time Frame: at day 0
|
at day 0
|
The Urgency premeditation perseverance and sensation seeking test
Time Frame: at day 0
|
at day 0
|
The Aggressive questionnaire score
Time Frame: at day 0
|
at day 0
|
The Hospital Anxiety and Depression Rating Scale
Time Frame: at day 0
|
at day 0
|
The dream content
Time Frame: at day 0
|
at day 0
|
The Mini mental state examination score
Time Frame: at day 1
|
at day 1
|
The California Verbal Learning Test score
Time Frame: at day 1
|
at day 1
|
The fluency verbal test score
Time Frame: at day 1
|
at day 1
|
The Modified Wisconsin Card Sorting Test
Time Frame: at day 1
|
at day 1
|
The Stroop score
Time Frame: at day 1
|
at day 1
|
The Empan test score
Time Frame: at day 1
|
at day 1
|
The Visual Object and Space Perception Battery test score
Time Frame: at day 1
|
at day 1
|
The Luria motor sequences
Time Frame: at day 1
|
at day 1
|
The Rey-Osterrieth complex figure
Time Frame: at day 1
|
at day 1
|
The Lille Apathy Rating Scale score
Time Frame: at day 1
|
at day 1
|
The Iowa Gambling test score
Time Frame: at day 1
|
at day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Livia Fantini, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-300
- 2016-A01736-45 (Other Identifier: 2016-A01736-45)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson's Disease
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
University Hospital, GrenobleCompletedParkinson's Disease (Disorder)France
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
Universidade Federal de PernambucoCompletedParkinson's Disease.Brazil
-
Shanghai East HospitalShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaRecruitingIdiopathic Parkinson's DiseaseChina
-
Beijing Tiantan HospitalRecruitingPD - Parkinson's DiseaseChina
-
AbbVieActive, not recruitingParkinson's Disease (PD)United States, Australia
-
AbbVieCompletedParkinson's Disease (PD)United States, Australia
-
BlueRock TherapeuticsMemorial Sloan Kettering Cancer CenterActive, not recruitingAdvanced Parkinson's DiseaseUnited States, Canada
Clinical Trials on Video polysomnography
-
University Hospital, ToulouseGrenoble Institut des NeurosciencesTerminatedParkinson DiseaseFrance
-
Children's Hospital of Eastern OntarioThe Physicians' Services Incorporated FoundationRecruitingChild | Obstructive Sleep Apnea | Down SyndromeCanada
-
University Hospital, Strasbourg, FranceRecruitingBenign Epilepsy With Centro Temporal Spikes (BECTS) | Atypical Benign Partial Epilepsy (ABPE) | Epileptic Encephalopathy With Continuous Spike and Waves During Sleep (ECSWS)France
-
Assistance Publique - Hôpitaux de ParisRecruitingObstructive Sleep Apnea | Spinal Cord InjuriesFrance
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
University of MelbourneMonash University; Western Sydney Local Health District; Royal Prince Alfred... and other collaboratorsRecruitingMotor Neuron Disease / Amyotrophic Lateral SclerosisAustralia
-
Hospital Universitario San Juan de AlicanteCompletedInfections | Community Acquired Pneumonia | Sleep Apnea Syndrome | PolygraphySpain
-
Guy's and St Thomas' NHS Foundation TrustUniversity Hospital, RouenCompleted
-
Oasi Research Institute-IRCCSIRCCS San Raffaele; University of Cagliari, Cagliari, Italy; IRCCS- Institute...Not yet recruitingREM Sleep Behavior Disorder
-
Huai'an No.1 People's HospitalThe First Affiliated Hospital with Nanjing Medical University; Nanjing University...Recruiting