Real World Assessment of Resistance Breathing Device

NCT07187349 | Completed

• 2 other identifiers: IRB-2025-131R41AT012854-01
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Stress; Breathing Exercise; Stress Management

Keywords

Stress management; Resistance breathing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Problem-Focused Coping as Measured by the Coping Self-Efficacy Scale (CSES)

  From study enrollment to the end of the study at 2 weeks

• Perceived Stress as Measured by the Perceived Stress Scale (PSS_10)

  From study enrollment to the end of the study at 2 weeks.

Study Arms (1)

Undergraduate Exam Takers

College undergraduate students between the ages of 18-30 who will be involved in an academic examination period at Purdue University.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Undergradute students from Purdue University

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Livotion, LLC: lead
• Purdue University: collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 23, 2025
• Study Start: December 1, 2025
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)