Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS (CAPTURE ALS Smarwatch)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Body Temperature
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Body Temperature
时间窗: Up to 1 year
Body temperature in Degrees Celsius as measured by the Health Gauge smartwatch worn by the participant
Oxygen saturation
时间窗: Up to 1 year
Oxygen saturation in percent as measured using the Health Gauge smartwatch worn by participants
Heart rate
时间窗: Up to 1 year
Heart rate in beats per minute as measured using the Health Gauge smartwatch worn by participants
Respiratory rate
时间窗: Up to 1 year
Respiratory rate in breaths per minute as measured by the Health Gauge smartwatch worn by the participant
Step count
时间窗: Up to 1 year
Physical activity in step count as measured using the Health Gauge smartwatch worn by participants
Distance travelled
时间窗: Up to 1 year
Physical activity in distance travelled (meters) as measured using the Health Gauge smartwatch worn by participants
Calories
时间窗: Up to 1 year
Physical activity in calories as measured using the Health Gauge smartwatch worn by participants
Sleep stage
时间窗: Up to 1 year
Sleep stage in time in wake, light and deep stages as measured using the Health Gauge smartwatch worn by participants
次要结局
- 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)