Dehydration
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Mode Sensors AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single-arm prospective feasibility study
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 60 years
Exclusion criteria
* Known allergies or skin sensitivities to electrode hydrogel and/or acrylic-based adhesives * Non-intact skin such as skin breakdown where the device is to be placed (upper back) * Implantable pulse generators such as pacemakers and defibrillators * Any medical or psychiatric condition, which in the opinion of the investigator precludes participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean use time of the wearable sensor | Up to 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean and standard deviation of the device output variables | Up to 7 days | — |
| Stability of device measurements following weekly patch replacement | Day 8, 15, 22, 29 | Test-retest reliability of the investigational device will be investigated by assessing the correlation between impedance measurements (in Ohm) before and after device replacement. |
| The mean number of days the sensor provides valid measurements | Up to 7 days | — |
| User satisfaction | Day 8, 15, 22, 29 | Will be assessed using a likert scale from 1-5, where 1 represents strongly disagree and 5 represents strongly agree. |
| Frequency and severity of adverse device effects | Day 1-30 | — |
| Clinical assessment of hydration status | Day 1, 8, 15, 22, 29 | — |
Countries
Norway
Contacts
Primary ContactSigve N Aas, PhD
Backup ContactFrida Bremnes, M.Sc.
Outcome results
None listed