Hypothermia Due to Cold EnvironmentTHERMO25NCT04460339
Thermoregulation During a 25-km Open Water Race
An observational study of Hypothermia Due to Cold Environment, run by University Hospital, Caen at 1 site in France.
Trial summary
Open water swimming is a swimming discipline which takes place in outdoor water such as open oceans, lakes, and rivers. Elite swimmers are exposed to hypothermia when swimming in cold water, especially in long duration races, such as the 25-km race. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Hypothermia Due to Cold Environment
- What is being tested?
- Swimming participants in the 25-km
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 3 Jun 2020
- 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 15 to 45 years
- All sexes
- Child, Adult
Study population: All the competitors of the 25-km French Open Water Championship who volunteered for this study
Who may be able to join
- competitors of the 25-km French Open Water Championship
- participants who volunteered for this study
- written consent was obtained from all participants, as well as their legal representatives when applicable (i.e. parents for under age participants).
Who cannot join
- swallowing disorders
- transit disorders
- MRI scheduled within 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Body Core Temperature During a 25-km Open Water Race in Elite Swimmers: Identifying Predictors for Hypothermia and Dropouts
Open water swimming is a swimming discipline which takes place in outdoor water such as open oceans, lakes, and rivers. Elite swimmers are exposed to hypothermia when swimming in cold water, especially in long duration races, such as the 25-km race. The objective of this study is to evaluate the change in body core temperature in swimmers with continuous temperature monitoring during a 25-km race. The secondary objective is to identify the predictors of hypothermia and hypothermia-related drop-out.
- Conditions
- Hypothermia Due to Cold Environment
- Being tested
- Swimming participants in the 25-km
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swimming participants in the 25-kmOther
The 25-km race was the French national Open Championship event and participants were the swimmers registered for the race who volunteered to participate in this study
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Core Temperature
Measurement of Body Core Temperature using an ingestible electronic sensor (e-Celsius®, BodyCap , Caen, France) which provide a continuous validated measurement
Measured: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer
Change in Water Temperature
Measurement of the Water Temperature using an electronic sensor (iButton® Maxim Integrated) which provide a continuous validated measurement
Measured: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer
Secondary outcomes (7)
Body composition, body mass
Body mass (in kg) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).
Measured: One measurement assessed the day before the race
Body composition, fat mass
Fat mass (in kg, % of body mass [fat mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).
Measured: One measurement assessed the day before the race
Body composition, fat-free mass
Fat-free mass (in kg, % of body mass [fat-free mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).
Measured: One measurement assessed the day before the race
Body composition, muscle mass
Muscle mass (in kg, % of body mass [muscle mass and body mass were combined to report % of body mass) was measured using bioelectrical impedance analysis (mBCA 525, Seca, Germany).
Measured: One measurement assessed the day before the race
Perception of Cold
Immediately at the end of the race participants' perception of cold was assessed using the Cold Discomfort Scale (CDS, with rating from 0-to-10 over 10, where 0 indicates no experience of cold and 10 indicates unbearable cold)
Measured: One measurement assessed immediately at the end of the race
Performance
Time at each lap and swimming race timing was collected using the official swimming timing from the race organisers and French Federation
Measured: Time at each lap of 2500m and at the end of the race
Dropout rate
Swimmers who dropout were identified and cause for dropout was collected
Measured: During the swimming race and data were collected immediately after dropout for each swimmer who dropped out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Mar 2019
- Primary completion26 May 2019
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia Due to Cold EnvironmentStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joffrey Drigny, MD MSC, Principal investigator, CHU Caen Normandie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460339
- Sponsor's protocol ID
- THERMO25
- Acronym
- THERMO25
- Status last verified
- Jul 2020
- First submitted
- 27 Jun 2020
- Last updated
- 26 Mar 2025
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Body Core Temperature During a 25-km Open Water Race in Elite Swimmers: Identifying Predictors for Hypothermia and Dropouts
- ClinicalTrials.gov ID
- NCT04460339
- Acronym / sponsor ID
- THERMO25 / THERMO25
- Conditions
- Hypothermia Due to Cold Environment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 26 May 2019 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 7 Jul 2020 (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.
Open water swimming is a swimming discipline which takes place in outdoor water such as open oceans, lakes, and rivers. Elite swimmers are exposed to hypothermia when swimming in cold water, especially in long duration races, such as the 25-km race. The objective of this study is to evaluate the change in body core temperature in swimmers with continuous temperature monitoring during a 25-km race. The secondary objective is to identify the predictors of hypothermia and hypothermia-related drop-out.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All the competitors of the 25-km French Open Water Championship who volunteered for this study
Key inclusion criteria (3 listed)
- competitors of the 25-km French Open Water Championship
- participants who volunteered for this study
- written consent was obtained from all participants, as well as their legal representatives when applicable (i.e. parents for under age participants).
Key exclusion criteria (3 listed)
- swallowing disorders
- transit disorders
- MRI scheduled within 48 hours
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 |
|---|---|---|
| Swimming participants in the 25-kmThe 25-km race was the French national Open Championship event and participants were the swimmers registered for the race who volunteered to participate in this study | Other | – |
Primary outcome
Change in Body Core Temperature
Time frame: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer
Measurement of Body Core Temperature using an ingestible electronic sensor (e-Celsius®, BodyCap , Caen, France) which provide a continuous validated measurement
Change in Water Temperature
Time frame: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer
Measurement of the Water Temperature using an electronic sensor (iButton® Maxim Integrated) which provide a continuous validated measurement
7 secondary outcomes
Body composition, body mass
Time frame: One measurement assessed the day before the race
Body composition, fat mass
Time frame: One measurement assessed the day before the race
Body composition, fat-free mass
Time frame: One measurement assessed the day before the race
Body composition, muscle mass
Time frame: One measurement assessed the day before the race
Perception of Cold
Time frame: One measurement assessed immediately at the end of the race
Performance
Time frame: Time at each lap of 2500m and at the end of the race
Dropout rate
Time frame: During the swimming race and data were collected immediately after dropout for each swimmer who dropped out
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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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.
Joffrey Drigny, MD MSC principal investigator
CHU Caen Normandie
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 Hypothermia Due to Cold Environment, run by University Hospital, Caen at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 26 Mar 2025. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Body Core Temperature (time frame: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer). The study lists 2 primary outcomes in all. 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 26 Mar 2025.