Scalable Intervention for Stress Management

Livotion, LLC

Status: Enrolling

Conditions: Diaphragmatic Breathing; Stress

Treatments: Device: Electronic Resistance Breathing Device; Device: Resistance Breathing Device

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07127575

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

IRB-2025-935

Details and patient eligibility

About

The purpose of this research is to measure the acceptance of a resistance breathing intervention and to assess whether it produces physiological and subjective effects in a laboratory setting.

Full description

College students experience a wide range of stressors during their studies, with many students experiencing levels of stress that can be clinically significant, such as anxiety or depression. Counseling centers on college campuses have seen a rise in students seeking mental health support or stress relief, but there exists a discrepancy in the level of need versus the support that can be provided. Stress management interventions, such as self-care mobile applications and devices, have risen in popularity given their relative accessibility and implementation of stress relieving interventions such as regulated breathing. Regulated breathing has been shown to be a reliable and effective form of stress relief, however its implementation within various eHealth interventions and related devices can come into conflict when used in educational settings. Mobile apps and biofeedback devices (e.g., chest straps, inhalers), can be contextually inappropriate, cumbersome, and potentially stigmatizing for students. To overcome these barriers, the PI developed the AIRpen, a simple, affordable, multi-functional stress management device that is designed to fit into the fabric of students' lives to potentially optimize the delivery, practice, and fidelity of diaphragmatic breathing (DB) interventions in real- world settings. With anecdotal and empirical evidence supporting the device as feasible and acceptable in real-world academic settings, this study will build upon prior work and measure the acceptance of the intervention and assess whether using the original and a "smart" version of the device as a stress relieving tool produces physiological and subjective effects in a laboratory setting.

Enrollment: 60 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 60-minute study involving heart rate monitoring, survey completion, training, a stress test, and device utilization

Exclusion criteria

-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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Base AIRpen

Experimental group

Description:

In this arm, participants will utilize an AIRpen after completing an arithmetic based stress test during a decompression period. Participants will engage in diaphragmatic breathing and other stress reducing behaviors like fidgeting or clicking using the AIRpen while physiological data is measured with an ear sensor and audio recordings.

Treatment:

Device: Resistance Breathing Device

Smart AIRpen

Experimental group

Description:

In this arm, participants will utilize a SMART AIRpen after completing an arithmetic based stress test during a decompression period. Participants will engage in diaphragmatic breathing and other stress reducing behaviors like fidgeting or clicking using the Smart AIRpen while physiological data is measured with an ear sensor and audio recordings.

Treatment:

Device: Electronic Resistance Breathing Device

No AIRpen

No Intervention group

Description:

In this arm, participants will be asked to sit quietly following an arithmetic based stress test during a decompression period. Physiological data will be measured with an ear sensor and audio recordings.