Hydration Monitor Validation in Elderly

Dehydration Clinical Trial

Official title:

The Validity of Ultrasound Velocity to Assess Hydration Status of Elderly Residing in Assisted Living Facilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206633
• Other study ID #: HME-02
• Secondary ID: 2R44AG042990
• Status: Completed
• Phase: N/A
• First received: July 30, 2014
• Last updated: June 22, 2015
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2014
• Source: Artann Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

The subject pool will be comprised of 100 elderly (over 65 years old), male and female subjects who are residing in assisted living center. All subjects will provide written informed consent before participation. For the day prior testing and all testing days subjects will be encouraged to follow standard hydration guidelines for older adults by consuming 1200-2400 ml/day depending upon the body weight of subjects. The application of the HM will follow specific protocol based on the prototype HM user manual 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. To examine within-day and between-day variability and reliability of the HM a subgroup (N=25) of the 100 initial subjects will be selected. Within-day reliability will be evaluated by taking multiple measurements (3) during the day. Between-day reliability will include measurements (same time) for three consecutive days for the subgroup of 25 subjects. BIA measures will also be included during each of the time points for both within-day and between-day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• elderly ( above 65 years old)

• male and female subjects who is residing in assisted living centers

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dehydration

Intervention

Device:
• Hydration Monitor
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.

Locations

Country	Name	City	State
United States	Appalachian State University	Boone	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Artann Laboratories	Appalachian State University, National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To observe statistically significant changes in ultrasound velocity associated with normal daily variation of the individual hydration level of elderly		1 day	No