- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05830214
Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS
February 6, 2024 updated by: University of Alberta
Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS (CAPTURE ALS Smarwatch)
This observational study will use new smartwatch technology to continuously and remotely monitor the health of ALS patients and healthy controls over time.
This information will be used to develop digital biomarkers for ALS.
Study Overview
Status
Withdrawn
Detailed Description
This is an optional study that is conducted in parallel to CAPTURE ALS (NCT05204017).
In this exploratory, prospective, longitudinal study, CAPTURE ALS participants undergo remote physiological data collection using smartwatch technology.
Participants will wear a specialized smartwatch (Health Gauge AI-Based Wearable Device ) for the duration of the study.
ALS patients will be followed for 12 months, healthy controls will be followed for 8 months.
Digital questionnaires will monitor participant-related outcomes bi-monthly.
Gait assessments will be performed by ambulatory patients and healthy controls in clinic during CAPTURE ALS study visits to measure changes in walking activity.
Study Type
Observational
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
- Name: Program Manager
- Email: info@captureals.ca
Study Contact Backup
- Name: Sara Moradipoor
- Phone Number: 780-248-1805
- Email: moradipo@ualberta.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta
-
Contact:
- Sara Moradipoor
- Phone Number: 780-248-1805
- Email: moradipo@ualberta.ca
-
-
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
People living with ALS and related motor neuron diseases including ALS-Frontotemporal Dementia (ALS-FTD), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA) and asymptomatic individuals with a known ALS mutation
AND
Healthy controls that are age and sex matched to patients
Description
[PATIENTS]
Inclusion Criteria:
- Has ALS, classified as definite, probable, laboratory-supported probable, or possible ALS according to the revised El Escorial criteria or a related neurodegenerative disorder including ALS-FTD, PLS, PMA or asymptomatic individuals with a known ALS mutation (as previously confirmed during the individual's regular clinical care)
- Is the age of majority in their province of residence/treatment
- Has the cognitive capacity to provide informed consent
- Has proficiency in English or French in order to understand study instructions and respond to questionnaires
Exclusion Criteria:
- Is pregnant
- Has a history of active (clinically significant) skin disorders
- Has a history of allergic response to plastic materials
- Has an electronic implant of any kind (e.g. pacemaker)
- Has broken, damaged or irritated skin or rashes near the sensor application sites
- Is unstably housed or lack reliable contact information.
- Investigator judges that device retrieval will be difficult or unlikely
- Does not have a smartphone that will support the HG application
- Does not have daily access to a wireless connection
[HEALTHY CONTROLS]
Inclusion Criteria:
- Be between the ages of 40-80 unless age matched to a patient (+/-3 years) who is already enrolled.
- Is the age of majority in their province of residence/treatment
- Has the cognitive capacity to provide informed consent
- Has proficiency in English or French in order to understand study instructions and respond to questionnaires
Exclusion Criteria:
- Has a history of a neurological disease, including Central Nervous System disease (e.g., stroke, head injury, epilepsy) or Peripheral Nervous System disease (neuropathy, myopathy).
- Has a history of psychiatric disease (e.g., depression, bipolar disease) that is clinically diagnosed and/or with the current use of psychiatric medications (e.g., antidepressants) for an indication of a psychiatric disease.
- Is pregnant
- Has a history of active (clinically significant) skin disorders
- Has a history of allergic response to plastic materials
- Has an electronic implant of any kind (e.g. pacemaker)
- Has broken, damaged or irritated skin or rashes near the sensor application sites
- Is unstably housed or lack reliable contact information.
- Investigator judges that device retrieval will be difficult or unlikely
- Does not have a smartphone that will support the HG application
- Does not have daily access to a wireless connection
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Temperature
Time Frame: Up to 1 year
|
Body temperature in Degrees Celsius as measured by the Health Gauge smartwatch worn by the participant
|
Up to 1 year
|
Respiratory rate
Time Frame: Up to 1 year
|
Respiratory rate in breaths per minute as measured by the Health Gauge smartwatch worn by the participant
|
Up to 1 year
|
Oxygen saturation
Time Frame: Up to 1 year
|
Oxygen saturation in percent as measured using the Health Gauge smartwatch worn by participants
|
Up to 1 year
|
Heart rate
Time Frame: Up to 1 year
|
Heart rate in beats per minute as measured using the Health Gauge smartwatch worn by participants
|
Up to 1 year
|
Step count
Time Frame: Up to 1 year
|
Physical activity in step count as measured using the Health Gauge smartwatch worn by participants
|
Up to 1 year
|
Distance travelled
Time Frame: Up to 1 year
|
Physical activity in distance travelled (meters) as measured using the Health Gauge smartwatch worn by participants
|
Up to 1 year
|
Calories
Time Frame: Up to 1 year
|
Physical activity in calories as measured using the Health Gauge smartwatch worn by participants
|
Up to 1 year
|
Sleep stage
Time Frame: Up to 1 year
|
Sleep stage in time in wake, light and deep stages as measured using the Health Gauge smartwatch worn by participants
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed Up and Go (TUG)
Time Frame: Baseline
|
The TUG is used to assess changes in functional mobility.
Participants arise from a chair, walk forward 3 meters, turn around, walk back to the chair and sit.
The time to complete the test is measured.
|
Baseline
|
Timed Up and Go (TUG)
Time Frame: Month 4
|
The TUG is used to assess changes in functional mobility.
Participants arise from a chair, walk forward 3 meters, turn around, walk back to the chair and sit.
The time to complete the test is measured.
|
Month 4
|
Timed Up and Go (TUG)
Time Frame: Month 8
|
The TUG is used to assess changes in functional mobility.
Participants arise from a chair, walk forward 3 meters, turn around, walk back to the chair and sit.
The time to complete the test is measured.
|
Month 8
|
Timed Up and Go (TUG)
Time Frame: Month 12
|
The TUG is used to assess changes in functional mobility.
Participants arise from a chair, walk forward 3 meters, turn around, walk back to the chair and sit.
The time to complete the test is measured.
|
Month 12
|
10 Meter Walk
Time Frame: Baseline
|
The 10 Meter Walk Test is a performance measure used to assess walking speed over a short distance.
This task will be performed with and without serial 3s subtraction.
The time to walk 10 meters and the number of errors in the mental task are measured.
|
Baseline
|
10 Meter Walk
Time Frame: 4 Months
|
The 10 Meter Walk Test is a performance measure used to assess walking speed over a short distance.
This task will be performed with and without serial 3s subtraction.
The time to walk 10 meters and the number of errors in the mental task are measured.
|
4 Months
|
10 Meter Walk
Time Frame: 8 Months
|
The 10 Meter Walk Test is a performance measure used to assess walking speed over a short distance.
This task will be performed with and without serial 3s subtraction.
The time to walk 10 meters and the number of errors in the mental task are measured.
|
8 Months
|
10 Meter Walk
Time Frame: 12 Months
|
The 10 Meter Walk Test is a performance measure used to assess walking speed over a short distance.
This task will be performed with and without serial 3s subtraction.
The time to walk 10 meters and the number of errors in the mental task are measured.
|
12 Months
|
2-Minute Timed Walk Test (2MWT)
Time Frame: Baseline
|
The 2MWT assess overall gait function and endurance.
The total distance travelled in 2 minutes is measured.
|
Baseline
|
2-Minute Timed Walk Test (2MWT)
Time Frame: 4 Months
|
The 2MWT assess overall gait function and endurance.
The total distance travelled in 2 minutes is measured.
|
4 Months
|
2-Minute Timed Walk Test (2MWT)
Time Frame: 8 Months
|
The 2MWT assess overall gait function and endurance.
The total distance travelled in 2 minutes is measured.
|
8 Months
|
2-Minute Timed Walk Test (2MWT)
Time Frame: 12 Months
|
The 2MWT assess overall gait function and endurance.
The total distance travelled in 2 minutes is measured.
|
12 Months
|
Changes in ALS Assessment Questionnaire (ALSAQ-40) Mobility Sub-score
Time Frame: Changes from baseline at 1 year
|
Changes in self-reported physical mobility over 1 year as measured using the ALSAQ-40 mobility sub-score, lower scores indicate better mobility.
|
Changes from baseline at 1 year
|
Changes in Generalized Anxiety Disorder 7 (GAD-7) score
Time Frame: Changes from baseline at 1 year
|
Changes in self-reported anxiety over 1 year as measured using the GAD-7.
The total score for the 7 items ranges from 0-21, with 0-4 (none to minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), 15-21 (severe anxiety).
|
Changes from baseline at 1 year
|
Changes in ALSFRS-R Dyspnea and Orthopnea sub-scores
Time Frame: Changes from baseline at 1 year
|
Changes in self-reported dyspnea and orthopnea over 1 year as measured using the ALS Functional Rating Scale dyspnea and orthopnea sub-scores.
Each question is scored by the participant as "4" (never) to "0" (all of the time).
|
Changes from baseline at 1 year
|
Changes in Patient Health Questionnaire (PHQ-9) score
Time Frame: Changes from baseline at 1 year
|
Changes in self-reported depression over 1 year as measured using the PHQ-9.
The total score for the 9 items ranges from 0-27, with 0-4 (none-minimal depression), 5-9 (mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression), 20-27 (severe).
|
Changes from baseline at 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jake Hayward, MD, University of Alberta
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)
January 1, 2024
Primary Completion (Actual)
February 6, 2024
Study Completion (Actual)
February 6, 2024
Study Registration Dates
First Submitted
February 24, 2023
First Submitted That Met QC Criteria
April 14, 2023
First Posted (Actual)
April 26, 2023
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Dementia
- Atrophy
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Sclerosis
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Muscular Atrophy
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Muscular Atrophy, Spinal
Other Study ID Numbers
- Pro00125737
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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