Study of AIRpen for Stress Management in College Students

This study is looking at a new tool called the AIRpen, and a version with sensors called the Smart AIRpen, to help college students manage stress. These devices help you practice diaphragmatic breathing (deep belly breathing) and can also be used for fidgeting. The researchers want to see if these devices are easy to use and if they help reduce stress. They will measure how acceptable and usable the devices are over a 1-hour study period. This study is for college students aged 18 to 30 who can read and speak English. The current status of this study is unclear, and it plans to enroll 60 participants.

Study design
This is an interventional study with a planned enrollment of 60 participants. The study will test two devices: the Resistance Breathing Device (AIRpen) and the Electronic Resistance Breathing Device (Smart AIRpen).
What's involved
You would participate in a 60-minute study that includes heart rate monitoring, completing surveys, training on the device, a stress test, and using the device.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for device acceptability and usability are measured from enrollment to the end of a 1-hour study period.

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NCT07127575

Scalable Intervention for Stress Management

Recruiting
NAAges 18–30InterventionalTreatment
Livotion, LLC
~60 participants
Updated 2025-08-17 on ClinicalTrials.gov
What's tested:Resistance Breathing DeviceElectronic Resistance Breathing Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device Acceptability as Measured by the Acceptability of Intervention Measure (AIM)
Measured over From enrollment to end of 1 hour study period.
+1 more outcome measured
Stress
Diaphragmatic Breathing
1 sites across 1 states
Indiana1

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Eligibility criteria

Inclusion

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

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.
  • 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.