DehydrationHELDNCT05831800
Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals
A study testing Wearable bioimpedance sensor in people with Dehydration, run by Mode Sensors AS at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Wearable bioimpedance sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 14 Jun 2023to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Frida Bremnes, M.Sc. contact
Norway1 site, 1 recruiting
- Recruiting
Tempe Helse- og velferdssenter
Trondheim
Remi N Birkenfeldt, MD
Remi N Birkenfeldt, MD
About this study
Official title: 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.
- Conditions
- Dehydration
- Being tested
- Wearable bioimpedance sensor
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable bioimpedance sensorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Wearable bioimpedance sensor | Other | Not described Receives: Device: Wearable bioimpedance sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean use time of the wearable sensor
Measured: Up to 7 days
Secondary outcomes (6)
The mean number of days the sensor provides valid measurements
Measured: Up to 7 days
Mean and standard deviation of the device output variables
Measured: Up to 7 days
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.
Measured: Day 8, 15, 22, 29
Clinical assessment of hydration status
Measured: Day 1, 8, 15, 22, 29
User satisfaction
Will be assessed using a likert scale from 1-5, where 1 represents "strongly disagree" and 5 represents "strongly agree".
Measured: Day 8, 15, 22, 29
Frequency and severity of adverse device effects
Measured: Day 1-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start14 Jun 2023
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm prospective feasibility study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mode Sensors AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sigve N Aas, PhD, Study director, Mode Sensors AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831800
- Sponsor's protocol ID
- CTR0061A HELD
- Acronym
- HELD
- Status last verified
- Jun 2023
- First submitted
- 27 Mar 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals - A Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT05831800
- Acronym / sponsor ID
- HELD / CTR0061A HELD
- Conditions
- Dehydration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mode Sensors ASIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm prospective feasibility study
| Arm | Type | Receives |
|---|---|---|
| Wearable bioimpedance sensor | Other | Device: Wearable bioimpedance sensor |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 60 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable bioimpedance sensorThe 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. | Device | Wearable bioimpedance sensor |
Primary outcome
Mean use time of the wearable sensor
Time frame: Up to 7 days
6 secondary outcomes
The mean number of days the sensor provides valid measurements
Time frame: Up to 7 days
Mean and standard deviation of the device output variables
Time frame: Up to 7 days
Stability of device measurements following weekly patch replacement
Time frame: Day 8, 15, 22, 29
Clinical assessment of hydration status
Time frame: Day 1, 8, 15, 22, 29
User satisfaction
Time frame: Day 8, 15, 22, 29
Frequency and severity of adverse device effects
Time frame: Day 1-30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
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Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
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Hydration & Female Life Stages
Dehydration, Menstruation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frida Bremnes, M.Sc. contact
Sigve N Aas, PhD study director
Mode Sensors AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable bioimpedance sensor in people with Dehydration, run by Mode Sensors AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sigve N Aas, PhD (004741499074, sigve.aas@modesensors.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean use time of the wearable sensor (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.