SweatCYSUNCT06308432
Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists.
A study testing Low intensity, Low temperature and Low Humidity in people with Sweat, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Controlled, double-blind, crossover clinical trial with six parallel arms depending on the combination of temperature and humidity (22º and 40% humidity, 35º 40% humidity and 35º and 65% humidity), with two differents intensity, to investigate and validate the physiological use of a sensor in recreational road… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sweat
- What is being tested?
- Low intensity, Low temperature and Low Humidity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 19 Feb 2024to 20 May 2024
- Phase
- Interventional
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male cyclists with more than two years of cycling experience.
- Perform tests without fatigue.
- Road bike training at least twice a week.
Who cannot join
- Participants with chronic illness.
- Have a long-term injury that prevents you from training in the previous month.
- Inability to understand informed consent.
- Use of diuretics in the month prior to or during the measurement period.
Trial locations and contacts
1 site in 1 country.
About this study
Controlled, double-blind, crossover clinical trial with six parallel arms depending on the combination of temperature and humidity (22º and 40% humidity, 35º 40% humidity and 35º and 65% humidity), with two differents intensity, to investigate and validate the physiological use of a sensor in recreational road cyclists.
Read the detailed description
Subjects who meet the inclusion criteria will be recruited to participate in the clinical trial and perform the exercise sessions.
The cyclists in the study will have to make 7 visits to the laboratory. At the first visit, their aerobic performance will be evaluated by an incremental test to exhaustion with gas analysis. And in the next 6 visits they will have to perform a sustained intensity exercise with different environmental conditions according to the combination of temperature, humidity and intensity.
- Conditions
- Sweat
- Being tested
- Low intensity, Low temperature, Low Humidity, High intensity, High temperature
- Keywords
- Cyclist, Performance, Temperature, Humidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensityOther
The subject will perform the 30-minute test at an intensity of 50% of the power at which he/she has reached his/her VO2max.
Low temperatureOther
The performance test will be carried out in a room conditioned to a temperature of 22º.
Low HumidityOther
The performance test will be carried out in a room conditioned to 40% humidity.
High intensityOther
The subject will perform the 30-minute test at an intensity of 60% of the power at which he/she has reached his/her VO2max.
High temperatureOther
The performance test will be carried out in a room conditioned to a temperature of 35º.
High humidityOther
The performance test will be carried out in a room conditioned to 65% humidity.
| Study group | Role | What they receive |
|---|---|---|
| 22 degrees, 40% humidity and 50% intensity | Experimental | The room in which the 30-minute test will be performed will be at 22 degrees Celsius and 40% humidity.
The subject should perform the test at 50% of the power at which he reached his VO2max. Receives: Other: Low intensity; Other: Low temperature; Other: Low Humidity |
| 35 degrees, 40% humidity and 50% intensity | Experimental | The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 40% humidity.
The subject should perform the test at 50% of the power at which he reached his VO2max. Receives: Other: Low intensity; Other: Low Humidity; Other: High temperature |
| 35 degrees, 65% humidity and 50% intensity | Experimental | The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 65% humidity.
The subject should perform the test at 50% of the power at which he reached his VO2max. Receives: Other: Low intensity; Other: High temperature; Other: High humidity |
| 22 degrees, 40% humidity and 60% intensity | Experimental | The room in which the 30-minute test will be performed will be at 22 degrees Celsius and 40% humidity.
The subject should perform the test at 60% of the power at which he reached his VO2max. Receives: Other: Low temperature; Other: Low Humidity; Other: High intensity |
| 35 degrees, 40% humidity and 60% intensity | Experimental | The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 40% humidity.
The subject should perform the test at 60% of the power at which he reached his VO2max. Receives: Other: Low Humidity; Other: High intensity; Other: High temperature |
| 35 degrees, 65% humidity and 60% intensity | Experimental | The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 65% humidity.
The subject should perform the test at 60% of the power at which he reached his VO2max. Receives: Other: High intensity; Other: High temperature; Other: High humidity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sweat
The amount of sweat will be measured by a sensor placed on the back.
Measured: Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Secondary outcomes (7)
Microcapillary Blood
By means of a lancet puncture in the thumb of the finger, 70 ml of capillary blood will be extracted.This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood.
Measured: Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Heart Rate
The heart rate will be evaluated by means of a heart rate strap.
Measured: Changes of heart rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Fatigue
Rate of perceived exertion using Borg scale. En esta escala 0 representa nada fatigado y el 10 esfuerzo máximo.
Measured: Change of fatigue in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Temperature on the forehead
The temperature will be measured by an infrared thermometer.
Measured: Changes in Temperature on the forehead in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Temperature in the ear
The temperature will be measured by ear thermometer.
Measured: Changes in Temperature in the ear in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Sleep efficiency
Measured by accelerometry, with Actigraph wGT3X-BT
Measured: Changes in the sleep efficiency in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Karolinska drowsiness scale
Measured by Karolinska test
Measured: It will be measured the day after in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start19 Feb 2024
- Primary completion12 Apr 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SweatStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308432
- Sponsor's protocol ID
- UCAMCFE-00036
- Acronym
- CYSU
- Status last verified
- Jan 2024
- First submitted
- 15 Feb 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists.
- ClinicalTrials.gov ID
- NCT06308432
- Acronym / sponsor ID
- CYSU / UCAMCFE-00036
- Conditions
- Sweat
- Keywords
- Cyclist, Performance, Temperature, Humidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 13 Mar 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.
Controlled, double-blind, crossover clinical trial with six parallel arms depending on the combination of temperature and humidity (22º and 40% humidity, 35º 40% humidity and 35º and 65% humidity), with two differents intensity, to investigate and validate the physiological use of a sensor in recreational road cyclists.
Detailed description
Subjects who meet the inclusion criteria will be recruited to participate in the clinical trial and perform the exercise sessions.
The cyclists in the study will have to make 7 visits to the laboratory. At the first visit, their aerobic performance will be evaluated by an incremental test to exhaustion with gas analysis. And in the next 6 visits they will have to perform a sustained intensity exercise with different environmental conditions according to the combination of temperature, humidity and intensity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 22 degrees, 40% humidity and 50% intensity | Experimental | Other: Low intensity, Other: Low temperature, Other: Low HumidityThe room in which the 30-minute test will be performed will be at 22 degrees Celsius and 40% humidity. The subject should perform the test at 50% of the power at which he reached his VO2max. |
| 35 degrees, 40% humidity and 50% intensity | Experimental | Other: Low intensity, Other: Low Humidity, Other: High temperatureThe room in which the 30-minute test will be performed will be at 35 degrees Celsius and 40% humidity. The subject should perform the test at 50% of the power at which he reached his VO2max. |
| 35 degrees, 65% humidity and 50% intensity | Experimental | Other: Low intensity, Other: High temperature, Other: High humidityThe room in which the 30-minute test will be performed will be at 35 degrees Celsius and 65% humidity. The subject should perform the test at 50% of the power at which he reached his VO2max. |
| 22 degrees, 40% humidity and 60% intensity | Experimental | Other: Low temperature, Other: Low Humidity, Other: High intensityThe room in which the 30-minute test will be performed will be at 22 degrees Celsius and 40% humidity. The subject should perform the test at 60% of the power at which he reached his VO2max. |
| 35 degrees, 40% humidity and 60% intensity | Experimental | Other: Low Humidity, Other: High intensity, Other: High temperatureThe room in which the 30-minute test will be performed will be at 35 degrees Celsius and 40% humidity. The subject should perform the test at 60% of the power at which he reached his VO2max. |
| 35 degrees, 65% humidity and 60% intensity | Experimental | Other: High intensity, Other: High temperature, Other: High humidityThe room in which the 30-minute test will be performed will be at 35 degrees Celsius and 65% humidity. The subject should perform the test at 60% of the power at which he reached his VO2max. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male cyclists with more than two years of cycling experience.
- Perform tests without fatigue.
- Road bike training at least twice a week.
Key exclusion criteria (4 listed)
- Participants with chronic illness.
- Have a long-term injury that prevents you from training in the previous month.
- Inability to understand informed consent.
- Use of diuretics in the month prior to or during the measurement period.
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 |
|---|---|---|
| Low intensityThe subject will perform the 30-minute test at an intensity of 50% of the power at which he/she has reached his/her VO2max. | Other | 22 degrees, 40% humidity and 50% intensity, 35 degrees, 40% humidity and 50% intensity, 35 degrees, 65% humidity and 50% intensity |
| Low temperatureThe performance test will be carried out in a room conditioned to a temperature of 22º. | Other | 22 degrees, 40% humidity and 50% intensity, 22 degrees, 40% humidity and 60% intensity |
| Low HumidityThe performance test will be carried out in a room conditioned to 40% humidity. | Other | 22 degrees, 40% humidity and 50% intensity, 22 degrees, 40% humidity and 60% intensity, 35 degrees, 40% humidity and 50% intensity, 35 degrees, 40% humidity and 60% intensity |
| High intensityThe subject will perform the 30-minute test at an intensity of 60% of the power at which he/she has reached his/her VO2max. | Other | 22 degrees, 40% humidity and 60% intensity, 35 degrees, 40% humidity and 60% intensity, 35 degrees, 65% humidity and 60% intensity |
| High temperatureThe performance test will be carried out in a room conditioned to a temperature of 35º. | Other | 35 degrees, 40% humidity and 50% intensity, 35 degrees, 40% humidity and 60% intensity, 35 degrees, 65% humidity and 50% intensity, 35 degrees, 65% humidity and 60% intensity |
| High humidityThe performance test will be carried out in a room conditioned to 65% humidity. | Other | 35 degrees, 65% humidity and 50% intensity, 35 degrees, 65% humidity and 60% intensity |
Primary outcome
Sweat
Time frame: Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
The amount of sweat will be measured by a sensor placed on the back.
7 secondary outcomes
Microcapillary Blood
Time frame: Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Heart Rate
Time frame: Changes of heart rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Fatigue
Time frame: Change of fatigue in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Temperature on the forehead
Time frame: Changes in Temperature on the forehead in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Temperature in the ear
Time frame: Changes in Temperature in the ear in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Sleep efficiency
Time frame: Changes in the sleep efficiency in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Karolinska drowsiness scale
Time frame: It will be measured the day after in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
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 24 Jun 2024.
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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?
A study testing Low intensity, Low temperature and Low Humidity in people with Sweat, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 4 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 24 Jun 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 Spain. 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?
Sweat (time frame: Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)). 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 24 Jun 2024.