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

NCT05830214 | Withdrawn

• 1 other identifier: Pro00125737
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis; Muscular Atrophy, Progressive; Frontotemporal Dementia; Healthy

Outcome Measures

Primary Outcomes (8)

• Body Temperature

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

  Up to 1 year

• Respiratory rate

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

  Up to 1 year

• Oxygen saturation

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

  Up to 1 year

• Heart rate

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

  Up to 1 year

• Step count

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

  Up to 1 year

• Distance travelled

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

  Up to 1 year

• Calories

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

  Up to 1 year

• 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 Outcomes (16)

• Timed Up and Go (TUG)

  Baseline

• Timed Up and Go (TUG)

  Month 4

• Timed Up and Go (TUG)

  Month 8

• Timed Up and Go (TUG)

  Month 12

• 10 Meter Walk

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• \[HEALTHY CONTROLS\]
• 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
• 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).

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Muscular Atrophy, Spinal; Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jake Hayward, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: April 26, 2023
• Study Start: January 1, 2024
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

CA (1)