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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01736-45 | Other Identifier | 2016-A01736-45 |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with PD-RBD | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video polysomnography | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| presence of REM sleep Behavior Disorder confirmed during the video polysomnography | at day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| The REM sleep Behavior Disorder severity measured by the REM sleep Behavior Disorder scale | at day 0 | |
| The Unified Parkinson disease Rating scale score | at day 0 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 0473751195 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Livia FANTINI | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D020187 | REM Sleep Behavior Disorder |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| The behavioral disorders measured by the Ardouin Scale of Behavior in Parkinson's Disease score |
| at day 0 |
| - The Orthostatic hypotension measured by the Scale for outcomes in PD- autonomic questionnaire | at day 0 |
| The impulsivity measured by the Test of Kirby score | at day 0 |
| The impulsivity measured by the Stop signal reaction time score | at day 0 |
| The Hoehn and Yahr scale score | at day 0 |
| The Non-motor symptoms Questionnaire score | at day 0 |
| The Epworth sleepiness scale score | at day 0 |
| The Urgency premeditation perseverance and sensation seeking test | at day 0 |
| The Aggressive questionnaire score | at day 0 |
| The Hospital Anxiety and Depression Rating Scale | at day 0 |
| The dream content | at day 0 |
| The Mini mental state examination score | at day 1 |
| The California Verbal Learning Test score | at day 1 |
| The fluency verbal test score | at day 1 |
| The Modified Wisconsin Card Sorting Test | at day 1 |
| The Stroop score | at day 1 |
| The Empan test score | at day 1 |
| The Visual Object and Space Perception Battery test score | at day 1 |
| The Luria motor sequences | at day 1 |
| The Rey-Osterrieth complex figure | at day 1 |
| The Lille Apathy Rating Scale score | at day 1 |
| The Iowa Gambling test score | at day 1 |
| D001523 |
| Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |