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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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