DehydrationNCT02206581
Using Hydration Monitor to Detect Changes in the Hydration Status Athletes
An observational study of Dehydration, run by Artann Laboratories at 1 site in United States.
Trial summary
The study will aim to evaluate the correlation between changes in ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing an acute dehydration and rehydration. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Hydration Monitor
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2015
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The subject pool will be comprised of 100 young, healthy, physically active male and female subjects.
Who may be able to join
- male or female athletes
- ages 18-25 years old
Who cannot join
- open wounds or rashes on calf testing area
- active skin infection
- pregnant female subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Appalachian State University
Boone, North Carolina, 28608-2071
About this study
Official title: The Validity of Ultrasound Velocity to Detect Changes in the Hydration Status of Male and Female Athletes During Acute Dehydration and Rehydration
The study will aim to evaluate the correlation between changes in ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing an acute dehydration and rehydration. The study will also test the hypothesis that body dehydration is a generalized physiological process equally affected all body muscles by comparing the data obtained on calf and biceps muscles.
- Conditions
- Dehydration
- Being tested
- Hydration Monitor
- Keywords
- dehydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration MonitorDevice
| Study group | Role | What they receive |
|---|---|---|
| young healthy adult athletes | Hydration Monitor measurement of the ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing 3% acute dehydration and a 2-hr rehydration period Receives: Device: Hydration Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe statistically significant changes in ultrasound velocity associated with acute dehydration
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artann Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Appalachian State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206581
- Sponsor's protocol ID
- HME-01
- Other IDs
- 2R44AG042990
- Status last verified
- Jan 2016
- First submitted
- 30 Jul 2014
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of Ultrasound Velocity to Detect Changes in the Hydration Status of Male and Female Athletes During Acute Dehydration and Rehydration
- ClinicalTrials.gov ID
- NCT02206581
- Acronym / sponsor ID
- HME-01
- Conditions
- Dehydration
- Keywords
- dehydration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Artann LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Appalachian State University
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Aug 2014 (estimated)
- 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 study will aim to evaluate the correlation between changes in ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing an acute dehydration and rehydration. The study will also test the hypothesis that body dehydration is a generalized physiological process equally affected all body muscles by comparing the data obtained on calf and biceps muscles.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| young healthy adult athletes | – | Device: Hydration MonitorHydration Monitor measurement of the ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing 3% acute dehydration and a 2-hr rehydration period |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The subject pool will be comprised of 100 young, healthy, physically active male and female subjects.
Key inclusion criteria (2 listed)
- male or female athletes
- ages 18-25 years old
Key exclusion criteria (3 listed)
- open wounds or rashes on calf testing area
- active skin infection
- pregnant female subjects
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 |
|---|---|---|
| Hydration Monitor | Device | young healthy adult athletes |
Primary outcome
To observe statistically significant changes in ultrasound velocity associated with acute dehydration
Time frame: 2 hours
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 21 Jan 2016.
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Hydration & Female Life Stages
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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 Dehydration, run by Artann Laboratories 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 2 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 21 Jan 2016. 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?
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?
To observe statistically significant changes in ultrasound velocity associated with acute dehydration (time frame: 2 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 21 Jan 2016.