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Amyotrophic Lateral SclerosisNCT05830214

Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS

An observational study of Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis, run by University of Alberta at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
0 participants
Where
1 siteCanada
Study dates
Jan 2024to 6 Feb 2024
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: 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

Who may be able to join

  • 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
  • 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

Who cannot join

  • 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.
Show all 21Show fewer
  • 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]
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta

    Edmonton, Alberta, T6G 2B7

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Medical subject headings
Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Muscular Atrophy, Spinal, Frontotemporal Dementia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Temperature

    Body temperature in Degrees Celsius as measured by the Health Gauge smartwatch worn by the participant

    Measured: Up to 1 year

  2. Respiratory rate

    Respiratory rate in breaths per minute as measured by the Health Gauge smartwatch worn by the participant

    Measured: Up to 1 year

  3. Oxygen saturation

    Oxygen saturation in percent as measured using the Health Gauge smartwatch worn by participants

    Measured: Up to 1 year

  4. Heart rate

    Heart rate in beats per minute as measured using the Health Gauge smartwatch worn by participants

    Measured: Up to 1 year

  5. Step count

    Physical activity in step count as measured using the Health Gauge smartwatch worn by participants

    Measured: Up to 1 year

  6. Distance travelled

    Physical activity in distance travelled (meters) as measured using the Health Gauge smartwatch worn by participants

    Measured: Up to 1 year

  7. Calories

    Physical activity in calories as measured using the Health Gauge smartwatch worn by participants

    Measured: Up to 1 year

  8. Sleep stage

    Sleep stage in time in wake, light and deep stages as measured using the Health Gauge smartwatch worn by participants

    Measured: Up to 1 year

Secondary outcomes (16)

  1. Timed Up and Go (TUG)

    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.

    Measured: Baseline

  2. Timed Up and Go (TUG)

    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.

    Measured: Month 4

  3. Timed Up and Go (TUG)

    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.

    Measured: Month 8

  4. Timed Up and Go (TUG)

    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.

    Measured: Month 12

  5. 10 Meter Walk

    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.

    Measured: Baseline

  6. 10 Meter Walk

    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.

    Measured: 4 Months

  7. 10 Meter Walk

    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.

    Measured: 8 Months

  8. 10 Meter Walk

    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.

    Measured: 12 Months

  9. 2-Minute Timed Walk Test (2MWT)

    The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.

    Measured: Baseline

  10. 2-Minute Timed Walk Test (2MWT)

    The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.

    Measured: 4 Months

  11. 2-Minute Timed Walk Test (2MWT)

    The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.

    Measured: 8 Months

  12. 2-Minute Timed Walk Test (2MWT)

    The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.

    Measured: 12 Months

  13. Changes in ALS Assessment Questionnaire (ALSAQ-40) Mobility Sub-score

    Changes in self-reported physical mobility over 1 year as measured using the ALSAQ-40 mobility sub-score, lower scores indicate better mobility.

    Measured: Changes from baseline at 1 year

  14. Changes in Generalized Anxiety Disorder 7 (GAD-7) score

    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).

    Measured: Changes from baseline at 1 year

  15. Changes in ALSFRS-R Dyspnea and Orthopnea sub-scores

    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).

    Measured: Changes from baseline at 1 year

  16. Changes in Patient Health Questionnaire (PHQ-9) score

    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).

    Measured: Changes from baseline at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study startJan 2024 (estimated)
  3. Primary completion6 Feb 2024
  4. Study completion6 Feb 2024

Why it stopped: Difficulty procuring study device

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05830214
Sponsor's protocol ID
Pro00125737
Status last verified
Feb 2024
First submitted
24 Feb 2023
Last updated
8 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis, run by University of Alberta at 1 site in Canada.

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 8 inclusion and 21 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: withdrawn, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Temperature (time frame: Up to 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05830214.

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 8 Feb 2024.

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