Trials / Unknown
UnknownNCT05831800
Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals
Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals - A Prospective Feasibility Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Mode Sensors AS · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-06-14
- Primary completion
- 2024-12-20
- Completion
- 2024-12-20
- First posted
- 2023-04-26
- Last updated
- 2023-06-18
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT05831800. Inclusion in this directory is not an endorsement.