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
About this trial
This is an interventional diagnostic trial for Dehydration
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
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
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
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