Using Hydration Monitor to Detect Changes in the Hydratio... | NCT02206581

Studies
Using Hydration Monitor to Detect Changes in the Hydration Status Athletes

NCT02206581

Sponsor

Artann Laboratories

Status

Completed

Last Update Posted

Jan 21, 2016Estimated

Enrollment

82Actual

Phase

Not provided

Conditions

Dehydration

Interventions

Hydration Monitor

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2R44AG042990	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

May 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jul 30, 2014

First Submission Date that Met QC Criteria

Jul 30, 2014

First Posted Date

Aug 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2016

Last Update Posted Date

Jan 21, 2016Estimated

Name	Class
National Institutes of Health (NIH)	NIH
National Institute on Aging (NIA)	NIH
Appalachian State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Device: Hydration Monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydration Monitor	Device		young healthy adult athletes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To observe statistically significant changes in ultrasound velocity associated with acute dehydration		2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male or female athletes
ages 18-25 years old

Exclusion Criteria:

open wounds or rashes on calf testing area
active skin infection
pregnant female subjects

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

The subject pool will be comprised of 100 young, healthy, physically active male and female subjects.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Appalachian State University		Boone	North Carolina	28608-2071	United States

Condition Browse Module

MeSH Terms

ID	Term
D003681	Dehydration

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided