Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2017-02-28
2019-06-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
Video polysomnography
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.
Interventions
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Video polysomnography
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
45 Years
85 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Livia FANTINI
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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Chu Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2016-A01736-45
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-300
Identifier Type: -
Identifier Source: org_study_id
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