AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV) (dBM-DEV)

August 26, 2024 updated by: University Hospital, Toulouse

AI-based Parkinson's Disease Risk Assessment and Prognosis - Digital Biomarkers Development, Validation and Verification Study (AI-PROGNOSIS dBM-DEV Study)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Toulouse, France
        • Neurology Toulouse Hospital
        • Sub-Investigator:
          • Olivier RASCOL
        • Contact:
        • Principal Investigator:
          • Margherita FABBRI
  • Germany
      • Dresden, Germany
        • Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pending)
        • Principal Investigator:
          • Björn Falkenburger
        • Contact:
          • Björn FALKENBURGER
  • Spain
      • Madrid, Spain
        • Hospital Ruber Internacional
        • Contact:
          • Monica KURTIS
        • Principal Investigator:
          • Monica Kurtis
  • United Kingdom
      • London, United Kingdom
        • King's college of London (Regulatory authorization pending)
        • Contact:
          • Dhaval TRIVEDI
        • Principal Investigator:
          • Dhaval TRIVEDI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

1 group of persons with RBD

1 group of persons without RBD

1 group of persons with Parkinson disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Development cohort of patients with known RBD
Detection of RBD signs by using the connected smartwach during 4 weeks
Device: connected smartwatch
The smartwatch is worn by the patient and data are sent automatically to a server that detects if there are signs of RBD.
Development cohort of matched controls = people who don't have RBD age and sex matched
Detection of RBD signs by using the connected smartwach during 4 weeks
Device: connected smartwatch
The smartwatch is worn by the patient and data are sent automatically to a server that detects if there are signs of RBD.
Confirmation cohort of parkinson disease patients = people who are supposed to have RBD
Detection of RBD signs by using the connected smartwach during 3 months
Device: connected smartwatch
The smartwatch is worn by the patient and data are sent automatically to a server that detects if there are signs of RBD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 4 weeks
the digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments.
Time Frame: 4 weeks (for development cohort) and 3 months (for confirmation cohort)
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.
Time Frame: 4 weeks (for development cohort) and 3 months (for confirmation cohort)
4 weeks (for development cohort) and 3 months (for confirmation cohort)
correlation between a) and b)
Time Frame: 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
4 weeks for a) 3 months for b)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Aristotle University Of Thessaloniki
European Union
University Hospital Carl Gustav Carus

Investigators

  • Principal Investigator: Margherita FABBRI, Toulouse Hospital
  • Study Chair: Björn FALKENBURGER, University Hospital Carl Gustav Carus of Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2024

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/23/0184 - RC31/24/0031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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