NCT02206633

Brief Summary

The study will aim to determine normal daily variation of the individual hydration level in longitudinal study on elderly in assisted living facility and assess a range of variation of individual hydration baselines for elderly in a normal physiologically hydrated state.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

July 30, 2014

Last Update Submit

June 22, 2015

Conditions

Dehydration

Keywords

dehydration

Outcome Measures

Primary Outcomes (1)

  • To observe statistically significant changes in ultrasound velocity associated with normal daily variation of the individual hydration level of elderly

    1 day

Study Arms (1)

Elderly, assisted living residents

Hydration Monitor ultrasound measurements

Device: Hydration Monitor

Interventions

Hydration MonitorDEVICE

Measurement of the ultrasound velocity with the Hydration Monitor for specific anatomic locations. Triplicate measurements will be made for each time-point. All subjects will also be measured for bioelectrical impedance analysis (BIA) and estimation of total body water using a leg-to-leg BIA machine.

Elderly, assisted living residents

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The subject pool will be comprised of 100 elderly (over 65 years old), male and female subjects who are residing in assisted living center

You may qualify if:

  • elderly ( above 65 years old)
  • male and female subjects who is residing in assisted living centers

You may not qualify if:

  • Open wounds or rashes on calf testing area
  • Visibly detectable edema
  • Active skin infection
  • Subjects will be excluded from the study if they can't physically stand on both feet without assistance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Appalachian State University

Boone, North Carolina, 28608-2071, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Armen Sarvazyan, PhD

    CSO, Artann Laboratories

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 1, 2014

Study Start

November 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

June 23, 2015

Record last verified: 2014-11

Locations

US(1)