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Evolution of RBD in PD

Primary Purpose

REM Sleep Behavior Disorder, Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Video polysomnography
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for REM Sleep Behavior Disorder focused on measuring REM Sleep Behavior Disorder, Parkinson's Disease, REM sleep without Atonia

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chu Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with PD-RBD

Arm Description

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.

Outcomes

Primary Outcome Measures

presence of REM sleep Behavior Disorder confirmed during the video polysomnography

Secondary Outcome Measures

The REM sleep Behavior Disorder severity measured by the REM sleep Behavior Disorder scale
The Unified Parkinson disease Rating scale score
The behavioral disorders measured by the Ardouin Scale of Behavior in Parkinson's Disease score
- The Orthostatic hypotension measured by the Scale for outcomes in PD- autonomic questionnaire
The impulsivity measured by the Test of Kirby score
The impulsivity measured by the Stop signal reaction time score
The Hoehn and Yahr scale score
The Non-motor symptoms Questionnaire score
The Epworth sleepiness scale score
The Urgency premeditation perseverance and sensation seeking test
The Aggressive questionnaire score
The Hospital Anxiety and Depression Rating Scale
The dream content
The Mini mental state examination score
The California Verbal Learning Test score
The fluency verbal test score
The Modified Wisconsin Card Sorting Test
The Stroop score
The Empan test score
The Visual Object and Space Perception Battery test score
The Luria motor sequences
The Rey-Osterrieth complex figure
The Lille Apathy Rating Scale score
The Iowa Gambling test score

Full Information

First Posted
January 24, 2017
Last Updated
February 6, 2017
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03047408
Brief Title
Evolution of RBD in PD
Official Title
Evolution of REM Sleep Behavior Disorder in Parkinson's Disease Patients RBD Diagnosed Three Years Earlier
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2017 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
REM Sleep Behavior Disorder, Parkinson's Disease
Keywords
REM Sleep Behavior Disorder, Parkinson's Disease, REM sleep without Atonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with PD-RBD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Video polysomnography
Intervention Description
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.
Primary Outcome Measure Information:
Title
presence of REM sleep Behavior Disorder confirmed during the video polysomnography
Time Frame
at day 0
Secondary Outcome Measure Information:
Title
The REM sleep Behavior Disorder severity measured by the REM sleep Behavior Disorder scale
Time Frame
at day 0
Title
The Unified Parkinson disease Rating scale score
Time Frame
at day 0
Title
The behavioral disorders measured by the Ardouin Scale of Behavior in Parkinson's Disease score
Time Frame
at day 0
Title
- The Orthostatic hypotension measured by the Scale for outcomes in PD- autonomic questionnaire
Time Frame
at day 0
Title
The impulsivity measured by the Test of Kirby score
Time Frame
at day 0
Title
The impulsivity measured by the Stop signal reaction time score
Time Frame
at day 0
Title
The Hoehn and Yahr scale score
Time Frame
at day 0
Title
The Non-motor symptoms Questionnaire score
Time Frame
at day 0
Title
The Epworth sleepiness scale score
Time Frame
at day 0
Title
The Urgency premeditation perseverance and sensation seeking test
Time Frame
at day 0
Title
The Aggressive questionnaire score
Time Frame
at day 0
Title
The Hospital Anxiety and Depression Rating Scale
Time Frame
at day 0
Title
The dream content
Time Frame
at day 0
Title
The Mini mental state examination score
Time Frame
at day 1
Title
The California Verbal Learning Test score
Time Frame
at day 1
Title
The fluency verbal test score
Time Frame
at day 1
Title
The Modified Wisconsin Card Sorting Test
Time Frame
at day 1
Title
The Stroop score
Time Frame
at day 1
Title
The Empan test score
Time Frame
at day 1
Title
The Visual Object and Space Perception Battery test score
Time Frame
at day 1
Title
The Luria motor sequences
Time Frame
at day 1
Title
The Rey-Osterrieth complex figure
Time Frame
at day 1
Title
The Lille Apathy Rating Scale score
Time Frame
at day 1
Title
The Iowa Gambling test score
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia FANTINI
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

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Evolution of RBD in PD

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