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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05830214
• Other study ID #: Pro00125737
• Status: Withdrawn
• Start date: January 2024
• Est. completion date: February 6, 2024

Study information

• Verified date: February 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 6, 2024
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

[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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Healthy
• Motor Neuron Disease
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Pick Disease of the Brain
• Primary Lateral Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Temperature	Body temperature in Degrees Celsius as measured by the Health Gauge smartwatch worn by the participant	Up to 1 year
Primary	Respiratory rate	Respiratory rate in breaths per minute as measured by the Health Gauge smartwatch worn by the participant	Up to 1 year
Primary	Oxygen saturation	Oxygen saturation in percent as measured using the Health Gauge smartwatch worn by participants	Up to 1 year
Primary	Heart rate	Heart rate in beats per minute as measured using the Health Gauge smartwatch worn by participants	Up to 1 year
Primary	Step count	Physical activity in step count as measured using the Health Gauge smartwatch worn by participants	Up to 1 year
Primary	Distance travelled	Physical activity in distance travelled (meters) as measured using the Health Gauge smartwatch worn by participants	Up to 1 year
Primary	Calories	Physical activity in calories as measured using the Health Gauge smartwatch worn by participants	Up to 1 year
Primary	Sleep stage	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	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.	Baseline
Secondary	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.	Month 4
Secondary	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.	Month 8
Secondary	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.	Month 12
Secondary	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.	Baseline
Secondary	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.	4 Months
Secondary	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.	8 Months
Secondary	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.	12 Months
Secondary	2-Minute Timed Walk Test (2MWT)	The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.	Baseline
Secondary	2-Minute Timed Walk Test (2MWT)	The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.	4 Months
Secondary	2-Minute Timed Walk Test (2MWT)	The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.	8 Months
Secondary	2-Minute Timed Walk Test (2MWT)	The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.	12 Months
Secondary	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.	Changes from baseline at 1 year
Secondary	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).	Changes from baseline at 1 year
Secondary	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).	Changes from baseline at 1 year
Secondary	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).	Changes from baseline at 1 year