Scalable Intervention for Stress Management

NCT07127575 | Recruiting

• 2 other identifiers: IRB-2025-9351R41AT012854-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress; Diaphragmatic Breathing

Keywords

resistance breathing; stress management

Outcome Measures

Primary Outcomes (2)

• 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 enrollment to end of 1 hour study period.

• 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 enrollment until completion of 1 hour study period.

Secondary Outcomes (2)

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

  From enrollment to the end of the 1 hour study period

• Physiological Stress as Assessed with Heart Rate Monitoring

  From study enrollment to end of 1 hour study period

Study Arms (3)

Base AIRpen

EXPERIMENTAL

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.

Device: Resistance Breathing Device

Smart AIRpen

EXPERIMENTAL

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.

Device: Electronic Resistance Breathing Device

No AIRpen

NO INTERVENTION

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.

Interventions

Resistance Breathing Device DEVICE

The AIRpen is a multifunctional stress management tool that helps users engage in diaphragmatic breathing at differing resistance levels, as well as other common stress relieving behaviors such as fidgeting

Base AIRpen

Electronic Resistance Breathing Device DEVICE

The Smart AIRpen functions just as the original AIRpen device and has been augmented with sensors to measure use patterns to determine whether the AIRpen is being used for fidgeting or breathing.

Smart AIRpen

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

RECRUITING

Central Study Contacts

Milton E Aguirre, PhD

CONTACT

7654960782; meaguirr@purdue.edu

Amanda Case, PhD

CONTACT

amanda-case@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to one of three conditions. 20 will be in the no pen condition, 20 will be in the original AIRpen condition, and 20 will be in the smart AIRpen condition.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 17, 2025
• Study Start: August 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)