Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals
HELD
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2023
CompletedFirst Posted
Study publicly available on registry
April 26, 2023
CompletedStudy Start
First participant enrolled
June 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2024
CompletedJune 18, 2023
June 1, 2023
1.5 years
March 27, 2023
June 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Mean use time of the wearable sensor
Up to 7 days
Secondary Outcomes (6)
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
Day 8, 15, 22, 29
Clinical assessment of hydration status
Day 1, 8, 15, 22, 29
User satisfaction
Day 8, 15, 22, 29
- +1 more secondary outcomes
Study Arms (1)
Wearable bioimpedance sensor
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 60 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mode Sensors ASlead
Study Sites (1)
Tempe Helse- og velferdssenter
Trondheim, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sigve N Aas, PhD
Mode Sensors AS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2023
First Posted
April 26, 2023
Study Start
June 14, 2023
Primary Completion
December 20, 2024
Study Completion
December 20, 2024
Last Updated
June 18, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share