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

Sponsor

University of Alberta (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05830214

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis Primary Lateral Sclerosis Muscular Atrophy, Progressive Frontotemporal Dementia Healthy

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 Design

Study Type:

Observational

Anticipated Enrollment :

42 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS (CAPTURE ALS Smarwatch)

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Outcome Measures

Primary Outcome Measures

Body Temperature [Up to 1 year]
Body temperature in Degrees Celsius as measured by the Health Gauge smartwatch worn by the participant
Respiratory rate [Up to 1 year]
Respiratory rate in breaths per minute as measured by the Health Gauge smartwatch worn by the participant
Oxygen saturation [Up to 1 year]
Oxygen saturation in percent as measured using the Health Gauge smartwatch worn by participants
Heart rate [Up to 1 year]
Heart rate in beats per minute as measured using the Health Gauge smartwatch worn by participants
Step count [Up to 1 year]
Physical activity in step count as measured using the Health Gauge smartwatch worn by participants
Distance travelled [Up to 1 year]
Physical activity in distance travelled (meters) as measured using the Health Gauge smartwatch worn by participants
Calories [Up to 1 year]
Physical activity in calories as measured using the Health Gauge smartwatch worn by participants
Sleep stage [Up to 1 year]
Sleep stage in time in wake, light and deep stages as measured using the Health Gauge smartwatch worn by participants

Secondary Outcome Measures

Timed Up and Go (TUG) [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.
Timed Up and Go (TUG) [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.
Timed Up and Go (TUG) [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.
Timed Up and Go (TUG) [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.
10 Meter Walk [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.
10 Meter Walk [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.
10 Meter Walk [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.
10 Meter Walk [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.
2-Minute Timed Walk Test (2MWT) [Baseline]
The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.
2-Minute Timed Walk Test (2MWT) [4 Months]
The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.
2-Minute Timed Walk Test (2MWT) [8 Months]
The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.
2-Minute Timed Walk Test (2MWT) [12 Months]
The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.
Changes in ALS Assessment Questionnaire (ALSAQ-40) Mobility Sub-score [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 in Generalized Anxiety Disorder 7 (GAD-7) score [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 in ALSFRS-R Dyspnea and Orthopnea sub-scores [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 in Patient Health Questionnaire (PHQ-9) score [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

[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