Digital Biotyping of FSHD Patients and Controls

CompletedOBSERVATIONAL
Enrollment

58

Participants

Timeline

Start Date

April 14, 2019

Primary Completion Date

October 4, 2019

Study Completion Date

October 4, 2019

Conditions
Muscular Dystrophy, Facioscapulohumeral
Interventions
BEHAVIORAL

CHDR Monitoring Remotely (MORE)

CHDR MORE is a highly customizable platform which allows remote monitoring of patients and trial subjects, data ingestion, and data management. The current infrastructure includes an Android app to unobtrusively collect data from smartphone sensors, and a connection to the Withings Health online platform to collect wearable data. Data is stored on a secure server in a structured data scheme ensuring clear data management processes, forming a prerequisite for comprehensive data analysis. The Android app enables data collection from multiple smartphone sensors (e.g. location data, accelerometer and ambient light) as well as phone usage logs (e.g. app usage, calls and texts).

BEHAVIORAL

Withings Steel HR

The Withings Steel HR is a commercially available smartwatch that combines various sensors to measure activity (steps, sleep, etc.) and heart rate (HR). HR is measured using a PPG (photoplethysmogram, i.e. optically obtained volumetric measurement) based on a commercially available sensor (AS7000) incorporating low-noise and high-sensitivity analogue circuitry. The manufacturer supplies the algorithm for converting the PPG signal into HR values. Data is transferred from the watch to the smartphone using the Withings Health Mate app from where it will be uploaded to the output server.

BEHAVIORAL

Withings Body+ scale

Body composition (weight, BMI and Skeletal Muscle Mass) can be assessed with the Withings Body+ smart scale at home. A smart phone is required to store data and send collected data to the output server. The device does not require charging.

BEHAVIORAL

Withings Blood Pressure Monitor

Blood pressure can be assessed with the automated Withings Blood Pressure Monitor at home. A smart phone is required to store data and send collected data to the output server. The device does not require charging

Trial Locations (1)

2333 CL

Centre for Human Drug Research, Leiden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Facio Therapeutics

UNKNOWN

lead

Centre for Human Drug Research, Netherlands

OTHER

NCT04999735 - Digital Biotyping of FSHD Patients and Controls | Biotech Hunter | Biotech Hunter