Real World Assessment of Resistance Breathing Device

A Scalable Intervention for Stress Management Real World Assessment

The purpose of this study is to examine the usability and effectiveness of a stress management device during an academic exam period and asks the following questions:

• To what extent is a resistance breathing device (AIRpen) utilized by participants during the study period?
• What impact does utilizing a resistance breathing device have on participant's well-being when used during a stressful academic period?
• To what extent is a diaphragmatic breathing device acceptable for use when utilized during a noted stress-inducing period such as academic examinations?

Study Overview

• Status: Completed
• Conditions: Stress; Breathing Exercise; Stress Management

Detailed Description

This study aims to build upon prior work with a diaphragmatic breathing intervention, testing the acceptability and usability of a resistance breathing device for stress reduction (i.e., the AIRpen) amongst college students during the academic semester. Regulated breathing has been shown to be an accessible and effective form of stress reduction, with prior research identifying diaphragmatic breathing as a key form of stress reduction that can impart cognitive, emotional, and physical benefits. Accomplishing diaphragmatic breathing can be difficult however, as it is a skill which requires considerable practice and can be challenging to perform properly without assistance.

To address this, a number of eHealth and physical applications (e..g, inhalers, mediations apps, chest straps) have arisen which seek to assist individuals in regulating their breathing and facilitating diaphragmatic breathing. However, the suitability of such interventions varies greatly, and may not always be appropriate for different contexts. For college students especially, a group which experiences a wide range of stressors within the course of their studies, interventions such as eHealth mobile applications or inhalers may be cumbersome, contextually inappropriate, or potentially stigmatizing when utilized within their educational environment. To address this, the PI has developed the AIRpen, a simple, affordable, and multi-functional stress management and regulated breathing device which aims to blend into a student's environment and assist in achieving diaphragmatic breathing in a discreet and effective manner. With anecdotal and empirical evidence supporting the device as feasible and acceptable in real-world academic settings (Purdue IRB-2022-423), this study will build upon prior work and measure the acceptability and feasibility of the AIRpen, as well as it's effect on perceived stress and coping self-efficacy amongst college students. As the purpose of this study, which is being funded by the NIH, is to study use of the AIRpen amongst college aged individuals, college students are not a convenience sample but actually the target sample for the study.

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Purdue University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Undergradute students from Purdue University

Description

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 2-week long study involving survey completion, training, and AIRpen utilization during an academic examination period

Exclusion Criteria:

- Individuals with a diagnosis of anxiety or stress that require professional support to cope with such clinical levels of stress or anxiety should not enroll in the study in place of professional assistance

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Undergraduate Exam Takers; College undergraduate students between the ages of 18-30 who will be involved in an academic examination period at Purdue University.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Usability as Measured by a Modified Version of the System Usability Scale (SUS)	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.	From study enrollment to the end of the study at 2 weeks.
Device Acceptability as Measured by the Acceptability of Intervention Measure (AIM)	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.	From study enrollment to the end of the study at 2 weeks.
Device Feasibility as Measured by the Feasibility of Intervention Measure (FIM)	The Feasibility of Intervention Measure (FIM) measures the feasibility of an intervention through a 5-point Likert scale, and has been adapted in relation to the AIRpen. Statements relate to the overall feasibility of the intervention, with 1 indicating "Completely disagree" while 5 indicates (Completely agree), with a higher score indicating greater feasibility.	From study enrollment until the end of the study at 2 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Problem-Focused Coping as Measured by the Coping Self-Efficacy Scale (CSES)	The Coping Self-Efficacy Scale (CSES) measures an individual's degree of confidence that s/he can perform coping behaviors when faced with life challenges. The CSES consists of three subscales measuring Problem-focused Coping, Emotion-focused Coping, and Social Support Coping. The CSES is administered as a 26-item form, although for this study only the Problem-Focused Coping subscale is administered from 0 to 10. Scoring higher on problem-focused coping self-efficacy means an individual has a strong belief in their ability to actively manage, reduce, or eliminate the root cause of a stressor	From study enrollment to the end of the study at 2 weeks
Perceived Stress as Measured by the Perceived Stress Scale (PSS_10)	The Perceived Stress Scale is a measure used to assess perceptions of recent stress. Individual scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.	From study enrollment to the end of the study at 2 weeks.

Collaborators and Investigators

• Sponsor: Livotion, LLC
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Actual): January 5, 2026
• Study Completion (Actual): January 5, 2026

Study Registration Dates

• First Submitted: September 18, 2025
• First Submitted That Met QC Criteria: September 18, 2025
• First Posted (Actual): September 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stress management; Resistance breathing
• Other Study ID Numbers: IRB-2025-13; 1R41AT012854-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No