A Study to Compare a New Body Worn Heart Rate, Temperature, and Activity Measurement Sensor to Existing Devices

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-011852
    Sponsor Protocol Number: 18-011852

About this study

The purpose of this study is to measure body temperature, heart rate, and activity with the newly developed disposable sensor and compare data to that collected by existing gold standard devices in order to quantify accuracy of the new device.  The comfort and durability of the adhesive used in the new sensor will also be evaluated.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Healthy adult.
  • Age 18 or older.

Exclusion Criteria: 

  • Known sensitivity to adhesives.
  • Unwillingness or inability to follow instructions for donning/doffing sensors.
  • Unwillingness to carry or follow instructions regarding use of the sensors for the duration of the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenton Kaufman, Ph.D.

Open for enrollment

Contact information:

Kathie Bernhardt

7760985

Bernhardt.Kathie@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20462459

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