A Study to Learn More about Using Sensor Data-Streams and Salivary Cortisol Measurements for the Detection of High and Low-levels of Mental Stress

Overview

  • Study type

    Interventional
  • 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: 17-009303
    Sponsor Protocol Number: 17-009303

About this study

The purpose of the current research study is to further the knowledge of how biometric data generated using wearables and other sensing devices relate to different levels of mental stress revealed by endocrine measurements of stress-associated hormone levels and self-reports of perceived stress. 

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.

Inclusion Criteria:

High- and Low-Level Stress Groups-

  1. Adults age 18 to 50
  2. Ability to provide informed consent
  3. Participants are able to wear the Empatica E4 at all times during the study
  4. Participants are able to provide saliva samples for cortisol concentration estimation multiple times throughout the length of the study.

Exclusion Criteria:

  1. Participants with reported history of diagnosed mood or anxiety disorders
  2. Participants taking any medication to treat diagnosed anxiety or mood disorders
  3. Participants who have used steroid-based medications within the past three years
  4. Participants with history of drug/alcohol abuse, and/or current tobacco use.
  5. Women who are pregnant or intend to become pregnant during 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

Brent Bauer, M.D.

Closed for enrollment

Contact information:

Joleen Bernau

(507)266-4606

bernau.joleen@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-20387133

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