Clinical trial NCT05830214: Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS
Official title: Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS (CAPTURE ALS Smarwatch)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Amyotrophic Lateral Sclerosis
Primary Lateral Sclerosis
Muscular Atrophy, Progressive
Frontotemporal Dementia
Healthy
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: \[PATIENTS\]

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

Primary outcomes:
measure: Body Temperature
timeFrame: Up to 1 year
measure: Respiratory rate
timeFrame: Up to 1 year
measure: Oxygen saturation
timeFrame: Up to 1 year
measure: Heart rate
timeFrame: Up to 1 year
measure: Step count
timeFrame: Up to 1 year
measure: Distance travelled
timeFrame: Up to 1 year
measure: Calories
timeFrame: Up to 1 year
measure: Sleep stage
timeFrame: Up to 1 year
Secondary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: Baseline
measure: Timed Up and Go (TUG)
timeFrame: Month 4
measure: Timed Up and Go (TUG)
timeFrame: Month 8
measure: Timed Up and Go (TUG)
timeFrame: Month 12
measure: 10 Meter Walk
timeFrame: Baseline
measure: 10 Meter Walk
timeFrame: 4 Months
measure: 10 Meter Walk
timeFrame: 8 Months
measure: 10 Meter Walk
timeFrame: 12 Months
measure: 2-Minute Timed Walk Test (2MWT)
timeFrame: Baseline
measure: 2-Minute Timed Walk Test (2MWT)
timeFrame: 4 Months
measure: 2-Minute Timed Walk Test (2MWT)
timeFrame: 8 Months
measure: 2-Minute Timed Walk Test (2MWT)
timeFrame: 12 Months
measure: Changes in ALS Assessment Questionnaire (ALSAQ-40) Mobility Sub-score
timeFrame: Changes from baseline at 1 year
measure: Changes in Generalized Anxiety Disorder 7 (GAD-7) score
timeFrame: Changes from baseline at 1 year
measure: Changes in ALSFRS-R Dyspnea and Orthopnea sub-scores
timeFrame: Changes from baseline at 1 year
measure: Changes in Patient Health Questionnaire (PHQ-9) score
timeFrame: Changes from baseline at 1 year
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jake Hayward, MD
role: PRINCIPAL_INVESTIGATOR
References: