Dehydrated, Water-Electrolyte Imbalance, MalnutritionNCT04937465
Explorative Study on a New Device' Ability to Register Hydration Change in Elderly Subjects During Rehabilitation.
An observational study of Dehydrated, Water-Electrolyte Imbalance, Malnutrition, run by Mode Sensors AS at 6 sites in Norway.
Trial summary
Test the ability of continuous measurements from a new sensor patch to set the hydration state in subjects who are malnourished/dehydrated or overhydrated or otherwise not optimally hydrated. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Dehydrated, Water-Electrolyte Imbalance, Malnutrition
- How many people
- 0 participants
- Where
- 6 sitesNorway
- Study dates
- 1 Nov 2021to 31 Dec 2022
- Phase
- Observational
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly people eligible for short term (3 - 5 weeks) rehabilitation because of either (i) malnutrition and or dehydration, or (ii) overhydration from heart failure treatment.
Who may be able to join
- Elderly patients eligible for rehabilitation
Who cannot join
- Subjects with end stage cancer
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Norway6 sites
Lilleborg helsehus
Oslo, 0569
Ryen helsehus
Oslo, 0580
Solvang helsehus
Oslo, 0664
Øya helsehus
Trondheim, 7030
Nidarvoll helsehus
Trondheim, 7037
Søbstad helsehus
Trondheim, 7078
About this study
Official title: CTR025 FAUN - Hydration Status
Test the ability of continuous measurements from a new sensor patch to set the hydration state in subjects who are malnourished/dehydrated or overhydrated or otherwise not optimally hydrated. Specifically, clinical examination, blood pressure, blood tests, and weight change at the admission and at the discharge will be used to establish the true hydration status of the subjects.
- Being tested
- No intervention done
- Medical subject headings
- Dehydration, Water-Electrolyte Imbalance, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention doneOther
No intervention was done. This was an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Elderly | Elderly (> 70 yrs) eligible for a short term rehabilitation Receives: Other: No intervention done |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydration state
Set correct hydration state with a sensitivity of 0.90 and a specificity of 0.80
Measured: During rehabilitation period (3 - 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Study was stopped because of covid-19 restrictions imposed for the next 9 months
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dehydrated, Water-Electrolyte Imbalance, MalnutritionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mode Sensors AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Norwegian Computing Center, Oslo Norway, Lilleborg helsehus, Oslo, Norway, Nidarvoll helsehus, Trondheim, Norway, Ryen helsehus, Trondheim, Norway, Solvang helsehus, Oslo, Norway, Søbstad helsehus, Trondheim, Norway, Øya helsehus, Trondheim, Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937465
- Sponsor's protocol ID
- CTR002 FAUN
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTR025 FAUN - Hydration Status
- ClinicalTrials.gov ID
- NCT04937465
- Acronym / sponsor ID
- CTR002 FAUN
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was stopped because of covid-19 restrictions imposed for the next 9 months
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mode Sensors ASIndustry (pharma, biotech, devices)
- Collaborators
- Norwegian Computing Center, Oslo Norway, Lilleborg helsehus, Oslo, Norway, Nidarvoll helsehus, Trondheim, Norway, Ryen helsehus, Trondheim, Norway, Solvang helsehus, Oslo, Norway, Søbstad helsehus, Trondheim, Norway, Øya helsehus, Trondheim, Norway
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Jun 2021 (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.
Test the ability of continuous measurements from a new sensor patch to set the hydration state in subjects who are malnourished/dehydrated or overhydrated or otherwise not optimally hydrated. Specifically, clinical examination, blood pressure, blood tests, and weight change at the admission and at the discharge will be used to establish the true hydration status of the subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | Other: No intervention doneElderly (> 70 yrs) eligible for a short term rehabilitation |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly people eligible for short term (3 - 5 weeks) rehabilitation because of either (i) malnutrition and or dehydration, or (ii) overhydration from heart failure treatment.
Key inclusion criteria (1 listed)
- Elderly patients eligible for rehabilitation
Key exclusion criteria (1 listed)
- Subjects with end stage cancer
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 |
|---|---|---|
| No intervention doneNo intervention was done. This was an observational study. | Other | Elderly |
Primary outcome
Hydration state
Time frame: During rehabilitation period (3 - 5 weeks)
Set correct hydration state with a sensitivity of 0.90 and a specificity of 0.80
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Dehydrated, Water-Electrolyte Imbalance, Malnutrition
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Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydrated, Water-Electrolyte Imbalance, Malnutrition, run by Mode Sensors AS at 6 sites 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 1 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: withdrawn, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydration state (time frame: During rehabilitation period (3 - 5 weeks)). 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 19 Nov 2021; AzTrials last refreshed its copy on 27 Oct 2026.