Body Temperature ChangesNCT06556628
Tympanic Thermometer Study
An observational study of Body Temperature Changes and Fever, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
The goal of this study is to collect febrile, healthy, and in some instances cold temperature data from human subjects ranging from newborns to geriatrics. This data will be used to develop a new thermometer. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Changes, Fever
- What is being tested?
- Increased Body Temperatures
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 31 May 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects recruited to participate in this study may range in age from normal weight (≥2.5kg), full-term (37 weeks gestation) newborns to geriatric adults. The subject may be anyone who is willing to have their temperature taken who also meets the eligibility criteria. Study subjects may have normal, febrile, or cold temperatures.
Who may be able to join
- Age: normal weight (≥2.5kg), full-term (37 weeks gestation) newborn to geriatric adult.
- Participant, legal guardian, or healthcare proxy is able to give consent to participate.
- Participant, legal guardian, or healthcare proxy speaks fluent English.
Who cannot join
- The subject does not meet the inclusion criteria.
- The subject has anatomical abnormalities that would affect temperature.
- The subject has blood or drainage in the external ear canal.
- The subject has had something in their ear for a prolonged period, such as a hearing aid or headphones. The subject may be included if the hearing aid or headphones are removed at least 30 minutes prior to taking ear temperature.
- The subject has been lying on ear within 30 minutes of data collection. The subject may be included if they wait 30 minutes prior to having an ear temperature measurement taken.
- The subject exhibits symptoms of an acute or chronic inflammatory condition of the external ear canal. An example would be swimmer's ear. The subject may be included if the acute or chronic inflammatory condition is isolated to one ear, then the other ear may be used for data collection.
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- The subject has an ear obstruction or excess cerumen build-up.
- The subject is in acute distress, i.e., severe pain, severe emotional distress or agitation that would inhibit them from participating in a tympanic ear temperature study.
- The subject has any known contraindication to oral, ear, or axillary temperature measurements.
- The subject has used ear drops in the last 8 hours. The subject may be included if the other ear was not medicated with ear drops in the last 8 hours.
- The subject (age 5+) has consumed food or drink, or smoked, within the last 20 minutes. The subject may be included if they wait 20 minutes prior to taking oral temperature.
- The subject has taken an antipyretic (ex: Tylenol, Motrin, Aspirin) in the last 120 minutes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disco Thermometer Engineering Study Protocol
The goal of this study is to collect febrile, healthy, and in some instances cold temperature data from human subjects ranging from newborns to geriatrics. This data will be used to develop a new thermometer.
- Conditions
- Body Temperature Changes, Fever
- Being tested
- Increased Body Temperatures
- Medical subject headings
- Body Temperature Changes, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased Body TemperaturesDevice
Collecting data on patients whose body temperatures increase due to fighting an illness.
| Study group | Role | What they receive |
|---|---|---|
| Fever | Elevated oral temperature of 37.5C or higher or elevated axillary temperature of 37.2C or higher. Receives: Device: Increased Body Temperatures | |
| Healthy | Oral temperature between 36-37.4C Axillary temperature between 36-37.1C | |
| Cold | Oral or axillary temperatures below 36C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Bias
The mean difference between output temperatures of the clinical thermometer under test
Measured: Immediately after the diagnostic test
Secondary outcomes (2)
Repeatability
Pooled standard deviation (over a selected group of subjects) of changes in multiple output temperatures taken from the same subject at the same measuring site with the same clinical thermometer by the same operator within a relatively short time
Measured: Immediately after the diagnostic test
Limits of Agreement
The magnitude of a potential disagreement between outputs of two clinical thermometers equal to double the standard deviation of output temperature differences when used on the same human subject.
Measured: Immediately after the diagnostic test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start11 Apr 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature ChangesStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556628
- Sponsor's protocol ID
- 60117201
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disco Thermometer Engineering Study Protocol
- ClinicalTrials.gov ID
- NCT06556628
- Acronym / sponsor ID
- 60117201
- Conditions
- Body Temperature Changes, Fever
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 16 Aug 2024 (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 goal of this study is to collect febrile, healthy, and in some instances cold temperature data from human subjects ranging from newborns to geriatrics. This data will be used to develop a new thermometer.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fever | – | Device: Increased Body TemperaturesElevated oral temperature of 37.5C or higher or elevated axillary temperature of 37.2C or higher. |
| Healthy | – | –Oral temperature between 36-37.4C Axillary temperature between 36-37.1C |
| Cold | – | –Oral or axillary temperatures below 36C |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects recruited to participate in this study may range in age from normal weight (≥2.5kg), full-term (37 weeks gestation) newborns to geriatric adults. The subject may be anyone who is willing to have their temperature taken who also meets the eligibility criteria. Study subjects may have normal, febrile, or cold temperatures.
Key inclusion criteria (3 listed)
- Age: normal weight (≥2.5kg), full-term (37 weeks gestation) newborn to geriatric adult.
- Participant, legal guardian, or healthcare proxy is able to give consent to participate.
- Participant, legal guardian, or healthcare proxy speaks fluent English.
Key exclusion criteria (12 listed)
- The subject does not meet the inclusion criteria.
- The subject has anatomical abnormalities that would affect temperature.
- The subject has blood or drainage in the external ear canal.
- The subject has had something in their ear for a prolonged period, such as a hearing aid or headphones. The subject may be included if the hearing aid or headphones are removed at least 30 minutes prior to taking ear temperature.
- The subject has been lying on ear within 30 minutes of data collection. The subject may be included if they wait 30 minutes prior to having an ear temperature measurement taken.
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 |
|---|---|---|
| Increased Body TemperaturesCollecting data on patients whose body temperatures increase due to fighting an illness. | Device | Fever |
Primary outcome
Clinical Bias
Time frame: Immediately after the diagnostic test
The mean difference between output temperatures of the clinical thermometer under test
2 secondary outcomes
Repeatability
Time frame: Immediately after the diagnostic test
Limits of Agreement
Time frame: Immediately after the diagnostic test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Body Temperature Changes and Fever, run by Baxter Healthcare Corporation at 1 site in United States.
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 3 inclusion and 12 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 16 Aug 2024. 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 United States. 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?
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?
Clinical Bias (time frame: Immediately after the diagnostic test). 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 16 Aug 2024.