Temperature Change, BodyNCT07397988
Feasibility of Wearable-Based Continuous Temperature Monitoring
An observational study of Temperature Change, Body, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to evaluate the feasibility of collecting synchronised continuous temperature data using wearable devices and a continuous core temperature reference under real-world conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Continuous Temperature Monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult participants (≥18 years) capable of providing informed consent and willing to comply with the project procedures, including ingestion of the capsule and continuous wearing of two wearable devices for around 48 hours until capsule excretion under free-living conditions.
Who may be able to join
- Written informed consent obtained prior to any project-specific procedures.
- Age 18 years or older at enrolment.
- Able and willing to comply with project procedures, including capsule ingestion, continuous wearable use for around 48 hours, and adherence to study instructions.
- Able to swallow the ingestible temperature capsule without difficulty.
- No contraindication to ingestible thermometry as assessed by the investigator.
Who cannot join
- General:
- Body weight < 36 kg.
- Women who are pregnant.
- Participation in another clinical investigation involving an investigational medicinal product or medical device within the 30 days preceding enrolment or previous enrolment in the current project.
- Enrolment of the Principal Investigator, project staff, their family members, employees, or other dependent persons.
- Inability to provide valid informed consent or significant language barrier preventing adequate understanding of procedures.
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- Implants \& MRI:
- Presence of any active Implantable Medical Device (AIMD), including Pacemakers, Implantable Cardioverter Defibrillators (ICDs), Deep Brain Stimulation (DBS) devices, or Left Ventricular Assist Devices (LVADs).
- Requirement for MRI scanning during the seven days following the capsule intake.
- Cognitive/Physical Status:
- Unconscious patients (prior to ingestion).
- Patients with special needs or disabilities preventing safe autonomous swallowing.
- Gastrointestinal:
- Known history of dysphagia or gag reflex troubles.
- Previous gastrointestinal surgery resulting in bowel stenosis.
- Current or planned surgical procedures on the GI tract (esophagus, stomach, intestines).
- Zenker's diverticulum or felinization of the esophagus.
- Risk or history of intestinal obstruction, strictures, or diverticula.
- Hypomotility disorders (e.g., ileus).
- Inflammatory Bowel Diseases including Crohn's disease or Ulcerative Colitis.
- Dermatological Exclusions (Rheo Vital+ Performance)
- Dermatological conditions, wounds, tattoos, oedema, inflammation, active venous access, or other impairments at the medial upper arm or axillary region that could interfere with correct placement or functioning of the wearable device.
- Excessive hair or concurrent devices that hinder correct sensor placement.
- Known allergy to plastics or latex.
- Temperature Management:
- Active external heating or cooling (e.g., cooling blankets).
- Note: Use of pharmacological antipyretics (oral/IV) is permitted.
- Further Medical Conditions:
- Currently existing acute back pain.
- Symptomatic herniated disc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospital Basel
Basel, 4031
Jens Eckstein, Prof. MD., 0041-61-3287689, jens.eckstein@usb.ch
About this study
Official title: Feasibility Study for Logistics and Data Stability of Continuous Temperature Monitoring Using a Wearable Device With a Continuous Core Temperature Reference Method
The aim of this study is to evaluate the feasibility of collecting synchronised continuous temperature data using wearable devices and a continuous core temperature reference under real-world conditions. The study focuses on workflow execution, data continuity, secure retrieval, and time-alignment without diagnostic or therapeutic intent.
Read the detailed description
Continuous temperature monitoring in real-world and free-living settings is operationally challenging due to intermittent standard measurements and context-dependent variability. This limits the ability to evaluate the integrity and stability of continuous temperature time-series and to test end-to-end data collection workflows.
This feasibility study is conducted to determine whether synchronised continuous temperature data from wearable devices and an ingestible core temperature reference can be collected, time-aligned, and retrieved reliably with acceptable participant and staff burden. The study generates feasibility evidence on workflow performance and data stability to inform the design of a subsequent confirmatory clinical investigation.
- Conditions
- Temperature Change, Body
- Being tested
- Continuous Temperature Monitoring
- Keywords
- Continuous temperature monitoring, Wearable devices, Feasibility study, Ingestible temperature capsule, Real-world monitoring
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Temperature MonitoringDevice
Participants wear investigational temperature sensors and ingest a core temperature capsule continuous data collection
| Study group | Role | What they receive |
|---|---|---|
| Ingestible temperature capsule | Not described Receives: Device: Continuous Temperature Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired Continuous Temperature Data Completeness
Participant-level paired data completeness (%) over the planned monitoring period, defined as the proportion of monitoring minutes with usable and time-aligned temperature data from both the wearable device(s) and the ingestible capsule.
Measured: Baseline to 48 hours
Secondary outcomes (17)
Recruitment and Retention Feasibility
Proportion of eligible participants enrolled among those approached and proportion of enrolled participants completing the planned monitoring period.
Measured: Baseline to 48 hours
Data continuity (wearable data)
Percent expected time with usable wearable data
Measured: Baseline to 48 hours
Data continuity (wearable data)
Categorised reasons for missing/invalid data
Measured: Baseline to 48 hours
Data continuity (capsule data)
frequency/duration of gaps
Measured: Baseline to 48 hours
Data continuity (capsule data)
Percent expected time with usable capsule data
Measured: Baseline to 48 hours
Data continuity (capsule data)
Categorised reasons for missing/invalid data
Measured: Baseline to 48 hours
Time-alignment success between wearable and capsule streams
Success rate of time synchronisation
Measured: Baseline to 48 hours
Time-alignment success between wearable and capsule streams
Distribution of residual alignment error after the defined alignment procedure (reported descriptively).
Measured: Baseline to 48 hours
Data retrieval workflow
Success rate of secure data retrieval/transfer
Measured: Baseline to 48 hours
Data retrieval workflow
Number of troubleshooting events
Measured: Baseline to 48 hours
Data retrieval workflow
Time spent per participant
Measured: Baseline to 48 hours
Tolerability Questionnair
Participant-reported tolerability and wear adherence assessed by a questionnaire
Measured: Baseline to 48 hours
Tolerability: skin discomfort
Incidence and nature of wearable skin discomfort
Measured: Baseline to 48 hours
Tolerability: GI discomfort
Capsule-related GI discomfort/delayed excretion (descriptive)
Measured: Baseline to 48 hours
Observed temperature trajectories
Descriptive summaries of temperature time courses; whether transient elevations >38.0°C were captured
Measured: Baseline to 48 hours
Baseline factors considered (descriptive stratification only)
Age and sex will be explored descriptively as potential drivers of data quality metrics
Measured: Baseline to 48 hours
Baseline factors considered (descriptive stratification only)
Age and sex will be explored descriptively as potential drivers of observed temperature dynamics.
Measured: Baseline to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, Prof. MD, Study chair, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397988
- Sponsor's protocol ID
- am25Eckstein4
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Logistics and Data Stability of Continuous Temperature Monitoring Using a Wearable Device With a Continuous Core Temperature Reference Method
- ClinicalTrials.gov ID
- NCT07397988
- Acronym / sponsor ID
- am25Eckstein4
- Conditions
- Temperature Change, Body
- Keywords
- Continuous temperature monitoring, Wearable devices, Feasibility study, Ingestible temperature capsule, Real-world monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Feb 2026 (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.
The aim of this study is to evaluate the feasibility of collecting synchronised continuous temperature data using wearable devices and a continuous core temperature reference under real-world conditions. The study focuses on workflow execution, data continuity, secure retrieval, and time-alignment without diagnostic or therapeutic intent.
Detailed description
Continuous temperature monitoring in real-world and free-living settings is operationally challenging due to intermittent standard measurements and context-dependent variability. This limits the ability to evaluate the integrity and stability of continuous temperature time-series and to test end-to-end data collection workflows.
This feasibility study is conducted to determine whether synchronised continuous temperature data from wearable devices and an ingestible core temperature reference can be collected, time-aligned, and retrieved reliably with acceptable participant and staff burden. The study generates feasibility evidence on workflow performance and data stability to inform the design of a subsequent confirmatory clinical investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ingestible temperature capsule | – | Device: Continuous Temperature Monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult participants (≥18 years) capable of providing informed consent and willing to comply with the project procedures, including ingestion of the capsule and continuous wearing of two wearable devices for around 48 hours until capsule excretion under free-living conditions.
Key inclusion criteria (5 listed)
- Written informed consent obtained prior to any project-specific procedures.
- Age 18 years or older at enrolment.
- Able and willing to comply with project procedures, including capsule ingestion, continuous wearable use for around 48 hours, and adherence to study instructions.
- Able to swallow the ingestible temperature capsule without difficulty.
- No contraindication to ingestible thermometry as assessed by the investigator.
Key exclusion criteria (30 listed)
- Body weight < 36 kg.
- Women who are pregnant.
- Participation in another clinical investigation involving an investigational medicinal product or medical device within the 30 days preceding enrolment or previous enrolment in the current project.
- Enrolment of the Principal Investigator, project staff, their family members, employees, or other dependent persons.
- Inability to provide valid informed consent or significant language barrier preventing adequate understanding of procedures.
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 |
|---|---|---|
| Continuous Temperature MonitoringParticipants wear investigational temperature sensors and ingest a core temperature capsule continuous data collection | Device | Ingestible temperature capsule |
Primary outcome
Paired Continuous Temperature Data Completeness
Time frame: Baseline to 48 hours
Participant-level paired data completeness (%) over the planned monitoring period, defined as the proportion of monitoring minutes with usable and time-aligned temperature data from both the wearable device(s) and the ingestible capsule.
17 secondary outcomes
Recruitment and Retention Feasibility
Time frame: Baseline to 48 hours
Data continuity (wearable data)
Time frame: Baseline to 48 hours
Data continuity (wearable data)
Time frame: Baseline to 48 hours
Data continuity (capsule data)
Time frame: Baseline to 48 hours
Data continuity (capsule data)
Time frame: Baseline to 48 hours
Data continuity (capsule data)
Time frame: Baseline to 48 hours
Time-alignment success between wearable and capsule streams
Time frame: Baseline to 48 hours
Time-alignment success between wearable and capsule streams
Time frame: Baseline to 48 hours
Data retrieval workflow
Time frame: Baseline to 48 hours
Data retrieval workflow
Time frame: Baseline to 48 hours
Data retrieval workflow
Time frame: Baseline to 48 hours
Tolerability Questionnair
Time frame: Baseline to 48 hours
Tolerability: skin discomfort
Time frame: Baseline to 48 hours
Tolerability: GI discomfort
Time frame: Baseline to 48 hours
Observed temperature trajectories
Time frame: Baseline to 48 hours
Baseline factors considered (descriptive stratification only)
Time frame: Baseline to 48 hours
Baseline factors considered (descriptive stratification only)
Time frame: Baseline to 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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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.
Jens Eckstein, Prof. MD study chair
University Hospital of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperature Change, Body, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 30 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: opening soon, as of the sponsor's last update on 9 Feb 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Eckstein, Prof. MD (0041-61-3287689, jens.eckstein@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired Continuous Temperature Data Completeness (time frame: Baseline to 48 hours). 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 9 Feb 2026.