Hypothermia, AccidentalTHERMOCOLDNCT05409560
Core Temperature Afterdrop in Cold-water Swimming
An observational study of Hypothermia, Accidental and Cold Water Swimming, run by University Hospital, Caen at 1 site in France.
Trial summary
A significant risk associated with hypothermia during exercise in a cold environment is the core temperature (T°core) afterdrop, which corresponds to a continuous fall in T°core during rewarming after hypothermia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia, Accidental, Cold Water Swimming
- What is being tested?
- Swimming participants in the 6-hour cold water swim
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2021to 19 Aug 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Swimmers participating in the 6-hour cold-water swim, qualifying for the English Channel swim at the Channel Swim Camp (Dinard, France).
Who may be able to join
- swimmers taking part in the Channel Swim Camp
- swimmers above 18 years of age
- swimmers willing and able to give informed consent for participation in the study
Who cannot join
- swallowing disorder
- chronic gastrointestinal disease
- MRI scheduled within 48 hours after the race.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Core Temperature Afterdrop and Factors Associated With Afterdrop in Cold-water Swimming
A significant risk associated with hypothermia during exercise in a cold environment is the core temperature (T°core) afterdrop, which corresponds to a continuous fall in T°core during rewarming after hypothermia. However, the rate and predictors of the afterdrop are unclear, particularly during prolonged cold water swimming.
The investigators propose to measure the changes in T°core during and after a cold water swim at 12.5-13°C qualifying for English Channel swim and to test the impact of anthropometric and swimming parameters on the duration of the T°core afterdrop. The hypotheses are that afterdrop is common during a prolonged cold water swimming event and that protective factors against T°core drop during cold water swimming (increased body fat and BMI) might, conversely, be associated with prolonged afterdrop.
- Conditions
- Hypothermia, Accidental, Cold Water Swimming
- Being tested
- Swimming participants in the 6-hour cold water swim
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swimming participants in the 6-hour cold water swimOther
The 6-hour cold water swim was the qualifying swim for the English Channel swim during the Channel Swim Camp Dinard 2021 and participants were the swimmers registered for the 6-hour cold water swim who volunteered to participate in this study
| Study group | Role | What they receive |
|---|---|---|
| Cold water swimmers | swimmers participating in the 6-hour cold water swim, qualifying for the English Channel Swim Receives: Other: Swimming participants in the 6-hour cold water swim |
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
Secondary outcomes (9)
Body composition, body 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
Distance
Distance of the swimming
Measured: The distance of swimming was collected from the organisers immediately after the race
Duration
Duration of the swimming
Measured: The duration of swimming was collected from the organisers immediately after the race
Individual characteristics, gender
The variable collected was the gender of participants
Measured: One evaluation assessed the day before the race
Individual characteristics, age
The variables collected was the age of participants
Measured: One evaluation assessed the day before the race
Individual characteristics, swimming habits
The variables collected was the swimming distance per week (total, swimming pool and open water)
Measured: One evaluation assessed the day before the race
Individual characteristics, training in cold environment
The variable collected was the type of specific training in cold environment (yes/no)
Measured: One evaluation assessed the day before the race
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start21 May 2021
- Primary completion23 May 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia, AccidentalStudies 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
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409560
- Sponsor's protocol ID
- THERMOCOLD
- Acronym
- THERMOCOLD
- Status last verified
- Jun 2022
- First submitted
- 17 Apr 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Analysis of Core Temperature Afterdrop and Factors Associated With Afterdrop in Cold-water Swimming
- ClinicalTrials.gov ID
- NCT05409560
- Acronym / sponsor ID
- THERMOCOLD / THERMOCOLD
- Conditions
- Hypothermia, Accidental, Cold Water Swimming
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 23 May 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 8 Jun 2022 (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.
A significant risk associated with hypothermia during exercise in a cold environment is the core temperature (T°core) afterdrop, which corresponds to a continuous fall in T°core during rewarming after hypothermia. However, the rate and predictors of the afterdrop are unclear, particularly during prolonged cold water swimming.
The investigators propose to measure the changes in T°core during and after a cold water swim at 12.5-13°C qualifying for English Channel swim and to test the impact of anthropometric and swimming parameters on the duration of the T°core afterdrop. The hypotheses are that afterdrop is common during a prolonged cold water swimming event and that protective factors against T°core drop during cold water swimming (increased body fat and BMI) might, conversely, be associated with prolonged afterdrop.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cold water swimmers | – | Other: Swimming participants in the 6-hour cold water swimswimmers participating in the 6-hour cold water swim, qualifying for the English Channel Swim |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Swimmers participating in the 6-hour cold-water swim, qualifying for the English Channel swim at the Channel Swim Camp (Dinard, France).
Key inclusion criteria (3 listed)
- swimmers taking part in the Channel Swim Camp
- swimmers above 18 years of age
- swimmers willing and able to give informed consent for participation in the study
Key exclusion criteria (3 listed)
- swallowing disorder
- chronic gastrointestinal disease
- MRI scheduled within 48 hours after the race.
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 6-hour cold water swimThe 6-hour cold water swim was the qualifying swim for the English Channel swim during the Channel Swim Camp Dinard 2021 and participants were the swimmers registered for the 6-hour cold water swim who volunteered to participate in this study | Other | Cold water swimmers |
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
9 secondary outcomes
Body composition, body 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
Distance
Time frame: The distance of swimming was collected from the organisers immediately after the race
Duration
Time frame: The duration of swimming was collected from the organisers immediately after the race
Individual characteristics, gender
Time frame: One evaluation assessed the day before the race
Individual characteristics, age
Time frame: One evaluation assessed the day before the race
Individual characteristics, swimming habits
Time frame: One evaluation assessed the day before the race
Individual characteristics, training in cold environment
Time frame: One evaluation assessed the day before the race
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.
- Individual participant dataSharing planned: Undecided
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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 Hypothermia, Accidental and Cold Water Swimming, 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). 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.