Real World Assessment of Resistance Breathing Device

NCT ID: NCT07187349

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-13
• Study Completion Date: 2025-11-07

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?

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.

Conditions

Stress; Breathing Exercise; Stress Management

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Undergraduate Exam Takers

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue University

OTHER

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Livotion, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Milton Aguirre, Ph.D.

Role: CONTACT

meaguirr@purdue.edu

765-496-0782

Amanda Case, Ph.D.

Role: CONTACT

amanda-case@uiowa.edu

(319) 335-0631

Other Identifiers

1R41AT012854-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-2025-13

Identifier Type: -

Identifier Source: org_study_id