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

Sponsor

Mode Sensors AS (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05831800

Collaborator

(none)

Enrollment

Location

Arm

19.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dehydration	Device: Wearable bioimpedance sensor	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single-arm prospective feasibility studySingle-arm prospective feasibility study

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 20, 2024

Anticipated Study Completion Date :

Dec 20, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Mean use time of the wearable sensor [Up to 7 days]

Secondary Outcome Measures

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]
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 [Day 1, 8, 15, 22, 29]
User satisfaction [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".
Frequency and severity of adverse device effects [Day 1-30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tempe Helse- og velferdssenter	Trondheim		Norway

Sponsors and Collaborators

Mode Sensors AS

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mode Sensors AS

ClinicalTrials.gov Identifier:

NCT05831800

Other Study ID Numbers:

CTR0061A HELD

First Posted:

Apr 26, 2023

Last Update Posted:

Apr 26, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Dehydration

Study Results

No Results Posted as of Apr 26, 2023