Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable bioimpedance sensor | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable bioimpedance sensor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean use time of the wearable sensor | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| The mean number of days the sensor provides valid measurements | Up to 7 days | |
| Mean and standard deviation of the device output variables | Up to 7 days | |
| Stability of device measurements following weekly patch replacement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sigve N Aas, PhD | Contact | 004741499074 | sigve.aas@modesensors.com | |
| Frida Bremnes, M.Sc. | Contact | frida.bremnes@modesensors.com |
| Name | Affiliation | Role |
|---|---|---|
| Sigve N Aas, PhD | Mode Sensors AS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe Helse- og velferdssenter | Recruiting | Trondheim | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Single-arm prospective feasibility study
Not provided
Not provided
Not provided
Not provided
|
Test-retest reliability of the investigational device will be investigated by assessing the correlation between impedance measurements (in Ohm) before and after device replacement. |
| Day 8, 15, 22, 29 |
| Clinical assessment of hydration status | 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". | Day 8, 15, 22, 29 |
| Frequency and severity of adverse device effects | Day 1-30 |
| D013568 | Pathological Conditions, Signs and Symptoms |