Parkinson DiseasedBM-DEVNCT06444789
AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)
An observational study of Parkinson Disease, run by University Hospital, Toulouse at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- connected smartwatch
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 20 Sep 2024to 15 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1 group of persons with RBD 1 group of persons without RBD 1 group of persons with Parkinson disease
Who may be able to join
- 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.
Show all 13Show fewer
- Able to use a compatible smartphone with the study app
- No history of RBD.
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
France1 site
Neurology Toulouse Hospital
Toulouse
Amel DRIF, amel.drif@inserm.fr
Margherita FABBRI
Germany1 site
Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pending)
Dresden
Björn FALKENBURGER
Björn FALKENBURGER
United Kingdom1 site
King's college of London (Regulatory authorization pending)
London
Dhaval TRIVEDI
Dhaval TRIVEDI
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- connected smartwatch
- Keywords
- REM sleep behaviour disorder
- Medical subject headings
- Parkinson Disease, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connected smartwatchDevice
The smartwatch is worn by the patient and data are sent automatically to a server that detects if there are signs of RBD.
| Study group | Role | What they receive |
|---|---|---|
| Development cohort of patients with known RBD | Detection of RBD signs by using the connected smartwach during 4 weeks Receives: Device: connected smartwatch | |
| 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 Receives: Device: connected smartwatch | |
| 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 Receives: Device: connected smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
the digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort
Measured: 4 weeks
Secondary outcomes (3)
correlation between a) and b)
- 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
- the score of the Epworth Sleepiness Scale at baseline, measured by the Spearman correlation coefficient, in a confirmation cohort
Measured: 4 weeks for a) 3 months for b)
Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments.
Measured: 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.
Measured: 4 weeks (for development cohort) and 3 months (for confirmation cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start20 Sep 2024 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, University Hospital Carl Gustav Carus, Aristotle University Of Thessaloniki
- Responsible party
- Sponsor
- Investigators
- Margherita FABBRI, Principal investigator, Toulouse HospitalBjörn FALKENBURGER, Study chair, University Hospital Carl Gustav Carus of Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444789
- Sponsor's protocol ID
- RC31/23/0184 - RC31/24/0031
- Acronym
- dBM-DEV
- Status last verified
- Aug 2024
- First submitted
- 14 May 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-based Parkinson's Disease Risk Assessment and Prognosis - Digital Biomarkers Development, Validation and Verification Study (AI-PROGNOSIS dBM-DEV Study)
- ClinicalTrials.gov ID
- NCT06444789
- Acronym / sponsor ID
- dBM-DEV / RC31/23/0184 - RC31/24/0031
- Conditions
- Parkinson Disease
- Keywords
- REM sleep behaviour disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- European Union, University Hospital Carl Gustav Carus, Aristotle University Of Thessaloniki
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Development cohort of patients with known RBD | – | Device: connected smartwatchDetection of RBD signs by using the connected smartwach during 4 weeks |
| Development cohort of matched controls = people who don't have RBD age and sex matched | – | Device: connected smartwatchDetection of RBD signs by using the connected smartwach during 4 weeks |
| Confirmation cohort of parkinson disease patients = people who are supposed to have RBD | – | Device: connected smartwatchDetection of RBD signs by using the connected smartwach during 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1 group of persons with RBD 1 group of persons without RBD 1 group of persons with Parkinson disease
Key inclusion criteria (13 listed)
- 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
- Healthy volunteers age and sex matched to the enrolled RBD patients.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| connected smartwatchThe smartwatch is worn by the patient and data are sent automatically to a server that detects if there are signs of RBD. | Device | Confirmation cohort of parkinson disease patients = people who are supposed to have RBD, Development cohort of matched controls = people who don't have RBD age and sex matched, Development cohort of patients with known RBD |
Primary outcome
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
3 secondary outcomes
correlation between a) and b)
Time frame: 4 weeks for a) 3 months for b)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Related InfoLink provided by the sponsor.
Related trials for Parkinson Disease
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Recruiting
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
Parkinson Disease, Freezing of Gait
Enrolling by invitationPhase 1/2
Lithium for Parkinson's: an Extension Trial
Parkinson Disease
Recruiting
Genetics and Aerobic Exercise to Slow Parkinson's Disease Trial
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margherita FABBRI principal investigator
Toulouse Hospital
Björn FALKENBURGER study chair
University Hospital Carl Gustav Carus of Dresden
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University Hospital, Toulouse at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadege ALGANS (33-561777204, algans.n@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.