Resistance Breathing Device for Stress

Overseen By Milton E Aguirre, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Livotion, LLC

Disqualifiers: Anxiety, Stress, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a breathing device to determine its effectiveness in reducing stress. Researchers aim to discover if the device can induce physical and emotional changes during stressful situations. Participants will use either a basic or smart version of the AIRpen (an electronic resistance breathing device) or sit quietly for comparison. This trial suits college students who can dedicate an hour to a stress test and use the breathing device. Those with significant stress or anxiety requiring professional help should seek support instead of joining this study. As an unphased trial, it offers participants the opportunity to contribute to innovative research on stress management techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this resistance breathing device is safe for stress reduction?

Research has shown that resistance breathing devices, such as the AIRpen, are generally easy to use. Studies highlight their design, which integrates smoothly into daily life, making them accessible and simple for managing stress. The AIRpen functions as both a stress-relief tool and a regular pen, enabling users to perform calming breathing exercises without disrupting their routine.

The design and practical use of these devices support their safety, suggesting they are user-friendly and safe for regular use. Additionally, similar device trials have reported no major side effects, indicating a low risk of harm. The focus remains on promoting relaxation through controlled breathing, a gentle and natural method to reduce stress. Therefore, the AIRpen is considered safe for most people as a stress-relief tool. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they introduce a novel approach to managing stress through resistance breathing devices. Unlike traditional stress-relief methods like meditation or medication, the AIRpen and Smart AIRpen provide immediate, hands-on engagement that encourages diaphragmatic breathing and stress-reducing activities like fidgeting. The Smart AIRpen is particularly innovative, potentially incorporating smart technology to enhance user experience and effectiveness. By using these devices, researchers hope to provide a tangible, quick-response tool for stress management, offering real-time physiological feedback through ear sensors and audio recordings.

What evidence suggests that this resistance breathing device is effective for stress?

This trial will compare the effectiveness of different resistance breathing devices for stress management. Studies have shown that devices like the AIRpen can effectively manage stress. Research indicates that diaphragmatic breathing, or deep breathing using the diaphragm, reduces stress by promoting relaxation. Participants in this trial will use either the Base AIRpen or the Smart AIRpen, both designed to incorporate these breathing techniques and include features that encourage stress-relieving activities, such as fidgeting. Initial findings suggest that both the Base and Smart AIRpen can lead to positive physical changes during stressful situations, potentially helping users feel calmer and more relaxed after using the device. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing stress who are interested in trying a resistance breathing intervention. Specific eligibility criteria have not been provided, so it's best to contact the study organizers for more details on who can participate.

Inclusion Criteria

I am 18 years old or older.

Be currently enrolled in a college or university

Be able to read, speak, and comprehend English

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants engage in stress management practices using the AIRpen or Smart AIRpen, or sit quietly without the device, following an arithmetic-based stress test.

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for physiological and subjective effects after the intervention.

1 hour

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Resistance Breathing Device
• Resistance Breathing Device

Trial Overview The study is testing two types of interventions: a Resistance Breathing Device and an Electronic Resistance Breathing Device, to see if they help manage stress by producing physiological and subjective effects.

How Is the Trial Designed?

Group I: Smart AIRpen Experimental Treatment 1 Intervention

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.

Group II: Base AIRpen Experimental Treatment 1 Intervention

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.

Group III: No AIRpen Active Control 1 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.

Who Is Running the Clinical Trial?

Livotion, LLC

Lead Sponsor

Purdue University

Collaborator

Trials

239

Recruited

72,200+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07127575

Scalable Intervention for Stress Management The purpose of this research is to measure the acceptance of a resistance breathing intervention and to assess whether it produces physiological ...

2. withpower.com withpower.com/trial/phase-stress-psychology-7-2025-cf211

Resistance Breathing Device for Stress The purpose of this research is to measure the acceptance of a resistance breathing intervention and to assess whether it produces physiological and subjective ...

3. ichgcp.net ichgcp.net/clinical-trials-registry/549168-scalable-intervention-for-stress-management

Stress Relief Study for College Students Using Breathing Device This study explores an innovative approach to stress management through the AIRpen device - a simple, affordable tool designed to help students ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10741869/

Breathing Practices for Stress and Anxiety Reduction Effective breath practices avoided fast-only breath paces and sessions <5 min, while including human-guided training, multiple sessions, and long-term practice.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0010482525015197

Use of machine learning for predicting stress episodes ... This study consists of a systematic literature review that aims to explore the potential of integrating wearable sensor data and machine learning (ML) ...

6. purdueseedlab.com purdueseedlab.com/pages/wellness-devices

Wellness Devices - (seed) LAB The AIRpen is a multi-functional device that pairs stress notification and regulated breathing functionalities with the real-world utility of a writing pen.

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Manufacturer and User Facility Device Experience (MAUDE ... The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and ...