Real World Assessment of Resistance Breathing Device

Livotion, LLC

Status: Not yet enrolling

Conditions: Breathing Exercise; Stress Management; Stress

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT07187349

1R41AT012854-01 (U.S. NIH Grant/Contract)

IRB-2025-13

Details and patient eligibility

About

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?

Full 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.

Enrollment: 47 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

47 participants in 1 patient group

Undergraduate Exam Takers

Description:

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