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Recruiting Not applicable

Scalable Intervention for Stress Management

NCT07127575 · tracked via the Priya Life Science USA tracker
Sponsor
Livotion, LLC
Phase
Not applicable
Started
2025-08-01
Last updated
2025-08-17

Condition(s) studied

StressDiaphragmatic Breathing

Investigational drug(s) / intervention(s)

Resistance Breathing DeviceElectronic Resistance Breathing Device

Resistance Breathing Device: The AIRpen is a multifunctional stress management tool that helps users engage in diaphragmatic breathing at differing resistance levels, as well as other common stress relieving behaviors such as fidgeting

Electronic Resistance Breathing Device: The Smart AIRpen functions just as the original AIRpen device and has been augmented with sensors to measure use patterns to determine whether the AIRpen is being used for fidgeting or breathing.

Study summary

The purpose of this research is to measure the acceptance of a resistance breathing intervention and to assess whether it produces physiological and subjective effects in a laboratory setting.

Eligibility

Sex
ALL
Min age
18 Years
Max age
30 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Be at least 18 years old * Be currently enrolled in a college or university * Be able to read, speak, and comprehend English * Be able and willing to complete a 60-minute study involving heart rate monitoring, survey completion, training, a stress test, and device utilization Exclusion Criteria: -Individuals diagnosed with anxiety or stress and require professional support to cope with these clinical levels of stress or anxiety should not enroll in the study in place of professional assistance.

Primary outcome measure(s)

  • Device Acceptability as Measured by the Acceptability of Intervention Measure (AIM) — From enrollment to end of 1 hour study period.
    The AIM measure is designed to assess the acceptability of a intervention, and has been adapted in relation to the AIRpen. Participants rate statements related to their usage and experience of the AIRpen and AIRpen website, with ratings ranging from "Completely Disagree" (1), to "Completely Agree" (5). Higher scores indicate higher acceptability of the intervention.
  • Device Usability as Measured by a Modified Version of the System Usability Scale (SUS) — From enrollment until completion of 1 hour study period.
    The System Usability Scale is a 10-item measure that address the usability and learnability of a system. The SUS has been modified to reflect the AIRpen intervention. Statements are ranked on a Likert scale for 1-5, with 1 indicating "Strongly Disagree" and 5 indicating "Strongly Agree". Raw scores are converted into a final score that ranges from 0-100, with a larger score indicating greater usability.

Trial sites (1)

FacilityCityRegionStatus
Purdue University West Lafayette Indiana Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07127575 on ClinicalTrials.gov ↗ ← All trials in the USA