Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals (HELD)

June 15, 2023 updated by: Mode Sensors AS

Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals - A Prospective Feasibility Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
      • Trondheim, Norway
        • Recruiting
        • Tempe Helse- og velferdssenter
        • Contact:
          • Remi N Birkenfeldt, MD
        • Principal Investigator:
          • Remi N Birkenfeldt, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Wearable bioimpedance sensor
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean use time of the wearable sensor
Time Frame: Up to 7 days
Up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean number of days the sensor provides valid measurements
Time Frame: Up to 7 days
Up to 7 days
Mean and standard deviation of the device output variables
Time Frame: Up to 7 days
Up to 7 days
Stability of device measurements following weekly patch replacement
Time Frame: 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.
Day 8, 15, 22, 29
Clinical assessment of hydration status
Time Frame: Day 1, 8, 15, 22, 29
Day 1, 8, 15, 22, 29
User satisfaction
Time Frame: 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".
Day 8, 15, 22, 29
Frequency and severity of adverse device effects
Time Frame: Day 1-30
Day 1-30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mode Sensors AS

Investigators

  • Study Director: Sigve N Aas, PhD, Mode Sensors AS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2023

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTR0061A HELD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe