An interventional study of Wearable bioimpedance sensor in Dehydration, sponsored by Mode Sensors AS. Recruiting at 1 site in Norway. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by Mode Sensors AS · Not applicable, Interventional, and Diagnostic
This is a single-arm prospective study, investigating the feasibility, usability, and safety of a wearable bioimpedance sensor in elderly individuals. The sensor is applied on the upper back of the subject, and will be replaced once weekly. The study will include four phases, each interspersed by an interim analysis. Each phase will have a duration of four weeks.
201 studies on the registry are indexed under Dehydration; 28 are open to participants now.
This study's planned enrollment of 40 is close to the median of 43 across 145 interventional studies indexed under Dehydration.
Browse Dehydration studies →Mode Sensors AS is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Device: Wearable bioimpedance sensor
The investigational device is an electronic bioimpedance-based, body-worn, battery-powered sensor intended to monitor changes in fluid balance. It is designed as an adhesive patch with four integrated electrodes. The outer electrodes are used to supply a low current, while the inner electrodes are used for voltage measurements.
Mean use time of the wearable sensor
Time frame: Up to 7 days
The mean number of days the sensor provides valid measurements
Time frame: Up to 7 days
Mean and standard deviation of the device output variables
Time frame: Up to 7 days
Stability of device measurements following weekly patch replacement
Test-retest reliability of the investigational device will be investigated by assessing the correlation between impedance measurements (in Ohm) before and after device replacement.
Time frame: Day 8, 15, 22, 29
Clinical assessment of hydration status
Time frame: Day 1, 8, 15, 22, 29
User satisfaction
Will be assessed using a likert scale from 1-5, where 1 represents "strongly disagree" and 5 represents "strongly agree".
Time frame: Day 8, 15, 22, 29
Frequency and severity of adverse device effects
Time frame: Day 1-30
Plan to share: No
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Mode Sensors AS