Evolution of RBD in PD

NCT03047408 | Unknown

• 2 other identifiers: CHU-3002016-A01736-45
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

REM Sleep Behavior Disorder; Parkinson's Disease

Keywords

REM Sleep Behavior Disorder; Parkinson's Disease; REM sleep without Atonia

Outcome Measures

Primary Outcomes (1)

• presence of REM sleep Behavior Disorder confirmed during the video polysomnography

  at day 0

Secondary Outcomes (24)

• 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

• 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

Study Arms (1)

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.

Procedure: Video polysomnography

Interventions

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.

patients with PD-RBD

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Parkinson Disease

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Livia FANTINI

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: open
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 9, 2017
• Study Start: February 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

FR (1)