- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04999735
Digital Biotyping of FSHD Patients and Controls
An Exploratory, Non-interventional Study to Biotype Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) and Controls Using Digital Technologies
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Zuid Holland
-
Leiden, Zuid Holland, Netherlands, 2333 CL
- Centre for Human Drug Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- Written informed consent is obtained before any assessment is performed.
- Males and females age 16+ years.
- Genetically confirmed FSHD.
- Symptomatic as demonstrated by Lamperti score >0.
- Fully functioning Android-based smartphone with Android version 5.0 or higher.
- Able to comply with the study procedures, prohibitions and restrictions (drug use) as specified in the protocol.
Controls inclusion criteria
Controls eligible for inclusion in this study have to fulfill all of the following criteria:
- Written informed consent is obtained before any assessment is performed.
- Males and females age 16+ years.
- Unrelated subjects without FSHD.
- Fully functioning Android-based smartphone with Android version 5.0 or higher.
- Able to comply with the study procedures, prohibitions and restrictions (drug use) as specified in the protocol.
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- Current or previously diagnosed illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study.
- Positive urine β-human chorionic gonadotropin (β-hCG) pregnancy test at Screening in women of childbearing potential.
- Wearing a pacemaker or other internal medical device (e.g. Vagus nerve stimulation (VNS), Deep Brain Stimulation (DBS)).
- Current enrollment in an interventional study.
Controls fulfilling any of the following criteria are not eligible for inclusion in this study:
- Current or previously diagnosed illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study.
- Positive urine β-human chorionic gonadotropin (β-hCG) pregnancy test at Screening in women of childbearing potential.
- Wearing a pacemaker or other internal medical device (e.g. Vagus nerve stimulation (VNS), Deep Brain Stimulation (DBS)).
- Current enrollment in an interventional study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with FSHD
CHDR Monitoring Remotely (MORE) Withings Steel HR Withings Body+ scale Withings Blood Pressure Monitor
|
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).
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.
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.
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
|
Healthy controls
CHDR Monitoring Remotely (MORE) Withings Steel HR Withings Body+ scale Withings Blood Pressure Monitor
|
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).
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.
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.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social activity
Time Frame: day 1 to day 42 (+/-3 days)
|
- Voice activation (probability of human voices in proximity)
|
day 1 to day 42 (+/-3 days)
|
Social activity
Time Frame: day 1 to day 42 (+/-3 days)
|
- Phone (length of call, last 3 digits of phone number, number known/unknown)
|
day 1 to day 42 (+/-3 days)
|
Social activity
Time Frame: day 1 to day 42 (+/-3 days)
|
- SMS (amount of characters, last 3 digits of phone number, number known/unknown)
|
day 1 to day 42 (+/-3 days)
|
Social activity
Time Frame: day 1 to day 42 (+/-3 days)
|
- App usage (categories of apps, start time, running in background/foreground)
|
day 1 to day 42 (+/-3 days)
|
Social activity
Time Frame: day 1 to day 42 (+/-3 days)
|
- Light sensor (lm)
|
day 1 to day 42 (+/-3 days)
|
Physical activity
Time Frame: day 1 to day 42 (+/-3 days)
|
- Acceleration
|
day 1 to day 42 (+/-3 days)
|
Physical activity
Time Frame: day 1 to day 42 (+/-3 days)
|
- Gyroscope
|
day 1 to day 42 (+/-3 days)
|
Physical activity
Time Frame: day 1 to day 42 (+/-3 days)
|
- Magnetic field
|
day 1 to day 42 (+/-3 days)
|
Physical activity
Time Frame: day 1 to day 42 (+/-3 days)
|
- Step count
|
day 1 to day 42 (+/-3 days)
|
Physical activity
Time Frame: day 1 to day 42 (+/-3 days)
|
- Google Places
|
day 1 to day 42 (+/-3 days)
|
Physical activity
Time Frame: day 1 to day 42 (+/-3 days)
|
- Relative location
|
day 1 to day 42 (+/-3 days)
|
Biometric data collected using the Withings Health platform:
Time Frame: day 1 to day 42 (+/-3 days)
|
Withings Steel HR smartwatch - Sleep pattern (time of sleep, sleep phases) |
day 1 to day 42 (+/-3 days)
|
Biometric data collected using the Withings Health platform:
Time Frame: day 1 to day 42 (+/-3 days)
|
Withings Steel HR smartwatch -Heart rate data |
day 1 to day 42 (+/-3 days)
|
Biometric data collected using the Withings Health platform:
Time Frame: day 1 to day 42 (+/-3 days)
|
Withings Steel HR smartwatch -Physical activity (steps, walking distance) |
day 1 to day 42 (+/-3 days)
|
Withings Body+ scale
Time Frame: day 1 to day 42 (+/-3 days)
|
Weight (kg)
|
day 1 to day 42 (+/-3 days)
|
Withings Body+ scale
Time Frame: day 1 to day 42 (+/-3 days)
|
Body composition (%)
|
day 1 to day 42 (+/-3 days)
|
Withings Blood Pressure Monitor
Time Frame: day 1 to day 42 (+/-3 days)
|
Systolic blood pressure (mmHg)
|
day 1 to day 42 (+/-3 days)
|
Withings Blood Pressure Monitor
Time Frame: day 1 to day 42 (+/-3 days)
|
Diastolic blood pressure (mmHg)
|
day 1 to day 42 (+/-3 days)
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHDR1861
- NL69288.056.19 (Other Identifier: Centrale Commissie Mensgebonden Onderzoek)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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