search
Back to results

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

Primary Purpose

Dehydration

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Wearable bioimpedance sensor
Sponsored by
Mode Sensors AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dehydration

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tempe Helse- og velferdssenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Wearable bioimpedance sensor

Arm Description

Outcomes

Primary Outcome Measures

Mean use time of the wearable sensor

Secondary Outcome Measures

The mean number of days the sensor provides valid measurements
Mean and standard deviation of the device output variables
Stability of device measurements following weekly patch replacement
Test-retest reliability of the investigational device will be investigated by assessing the correlation between impedance measurements (in Ohm) before and after device replacement.
Clinical assessment of hydration status
User satisfaction
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

Full Information

First Posted
March 27, 2023
Last Updated
June 15, 2023
Sponsor
Mode Sensors AS
search

1. Study Identification

Unique Protocol Identification Number
NCT05831800
Brief Title
Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals
Acronym
HELD
Official Title
Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals - A Prospective Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mode Sensors AS

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm prospective feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wearable bioimpedance sensor
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Wearable bioimpedance sensor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean use time of the wearable sensor
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
The mean number of days the sensor provides valid measurements
Time Frame
Up to 7 days
Title
Mean and standard deviation of the device output variables
Time Frame
Up to 7 days
Title
Stability of device measurements following weekly patch replacement
Description
Test-retest reliability of the investigational device will be investigated by assessing the correlation between impedance measurements (in Ohm) before and after device replacement.
Time Frame
Day 8, 15, 22, 29
Title
Clinical assessment of hydration status
Time Frame
Day 1, 8, 15, 22, 29
Title
User satisfaction
Description
Will be assessed using a likert scale from 1-5, where 1 represents "strongly disagree" and 5 represents "strongly agree".
Time Frame
Day 8, 15, 22, 29
Title
Frequency and severity of adverse device effects
Time Frame
Day 1-30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sigve N Aas, PhD
Phone
004741499074
Email
sigve.aas@modesensors.com
First Name & Middle Initial & Last Name or Official Title & Degree
Frida Bremnes, M.Sc.
Email
frida.bremnes@modesensors.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigve N Aas, PhD
Organizational Affiliation
Mode Sensors AS
Official's Role
Study Director
Facility Information:
Facility Name
Tempe Helse- og velferdssenter
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Remi N Birkenfeldt, MD
First Name & Middle Initial & Last Name & Degree
Remi N Birkenfeldt, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals

We'll reach out to this number within 24 hrs