Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS (CAPTURE ALS Smarwatch)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis
- Sponsor
- University of Alberta
- Locations
- 1
- Primary Endpoint
- Body Temperature
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •\[HEALTHY CONTROLS\]
Outcomes
Primary Outcomes
Body Temperature
Time Frame: Up to 1 year
Body temperature in Degrees Celsius as measured by the Health Gauge smartwatch worn by the participant
Oxygen saturation
Time Frame: Up to 1 year
Oxygen saturation in percent as measured using the Health Gauge smartwatch worn by participants
Heart rate
Time Frame: Up to 1 year
Heart rate in beats per minute as measured using the Health Gauge smartwatch worn by participants
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
Step count
Time Frame: Up to 1 year
Physical activity in step count as measured using the Health Gauge smartwatch worn by participants
Distance travelled
Time Frame: Up to 1 year
Physical activity in distance travelled (meters) as measured using the Health Gauge smartwatch worn by participants
Calories
Time Frame: Up to 1 year
Physical activity in calories as measured using the Health Gauge smartwatch worn by participants
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
Secondary Outcomes
- 2-Minute Timed Walk Test (2MWT)(12 Months)
- Timed Up and Go (TUG)(Month 12)
- 10 Meter Walk(12 Months)
- Changes in ALS Assessment Questionnaire (ALSAQ-40) Mobility Sub-score(Changes from baseline at 1 year)
- Changes in Generalized Anxiety Disorder 7 (GAD-7) score(Changes from baseline at 1 year)
- Changes in ALSFRS-R Dyspnea and Orthopnea sub-scores(Changes from baseline at 1 year)
- Changes in Patient Health Questionnaire (PHQ-9) score(Changes from baseline at 1 year)