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OpenTrials
Completed

NCT Number: NCT02206633

Hydration Monitor Validation in Elderly

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Appalachian State University

Boone, North Carolina, 28608-2071, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydration Monitor

Device

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.

Primary outcomes

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

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Artann Laboratories

Industry

Collaborators

  • Appalachian State University
  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 1, 2014
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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