Parkinson Disease
Conditions
Keywords
REM sleep behaviour disorder
Brief summary
dBM-dev study is a multicentre low-intervention research study which concerns REM sleep behaviour disorder (RBD) who is the best predictor for neurodegenerative diseases including Parkinson's disease (PD). RBD can only be confirmed by polysomnography, which is a cumbersome procedure. The main objective of this study is to identify a novel, robust dBM for the detection of RBD using smartwatch-based recordings of passive data.The study is conducted step-wise on two subsequent cohorts referred to as the development cohort and the confirmation cohort.
Detailed description
The development cohort comprises 30 patients with RBD and 30 matched controls on sex and age with patients RBD. The confirmation cohort comprises 30 patients with PD. Following a baseline visit comprising standard clinical evaluation and Parkinson questionnaires, participants will undergo daily-life dBM tracking over a duration of 4 weeks for development cohort and 3 months for confirmation cohort. Additionally, PD patients enrolled in the confirmation cohort will receive a polysomnography which permits to verificate if they have a RBD. The investigation is conducted in four European sites.
Interventions
DEVICEconnected smartwatch
The smartwatch is worn by the patient and data are sent automatically to a server that detects if there are signs of RBD.
Sponsors
European Union
University Hospital Carl Gustav Carus
Aristotle University Of Thessaloniki
University Hospital, Toulouse
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for development cohort: Group of RBD patients * Diagnosis of RBD (confirmed by polysomnography) * Able to use a compatible smartphone with the study app * Having a care partner with whom they share their bedroom at night Group of Healthy matched controls: * Healthy volunteers age and sex matched to the enrolled RBD patients. * Able to use a compatible smartphone with the study app * No history of RBD. Inclusion Criteria for confirmation cohort * Clinical confirmed diagnosis of PD * RBD Screening Questionnaire score : 3 - 12 points * Absence of dementia * Able to use a compatible smartphone with the study app * Having a care partner with whom they share their bedroom at night
Exclusion criteria
for all cohorts: Inability to consent for study procedures as judged by the investigator. Lacking motivation to participate in study procedures as judged by the investigator. Lack of social security.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of nights in a confirmation cohort in which RBD episodes are indicated by a score (digital biomarker) derived from passive actigraphy and photoplethysmography data captured by a smartwatch | 4 weeks | the digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| correlation between a) and b) | 4 weeks for a) 3 months for b) | 1. the incidence of daytime somnolence episodes per week indicated by a score (digital biomarker) derived from passive actigraphy and photoplethysmography data captured by a smartwatch. The digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort 2. the score of the Epworth Sleepiness Scale at baseline, measured by the Spearman correlation coefficient, in a confirmation cohort |
| Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments. | 4 weeks (for development cohort) and 3 months (for confirmation cohort) | — |
| Number of cognitive tasks completed by each participant relative to the number of scheduled cognitive tasks. | 4 weeks (for development cohort) and 3 months (for confirmation cohort) | — |
Countries
France, Germany, Spain, United Kingdom
Contacts
Primary ContactNadege ALGANS
Backup ContactAnna RIBYCKA
Outcome results
None listed