StressNCT07127575
Scalable Intervention for Stress Management
A study testing Resistance Breathing Device and Electronic Resistance Breathing Device in people with Stress and Diaphragmatic Breathing, run by Livotion, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Diaphragmatic Breathing
- What is being tested?
- Resistance Breathing Device and Electronic Resistance Breathing Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- -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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amanda Case, PhD contact
United States1 site, 1 recruiting
- Recruiting
Purdue University
West Lafayette, Indiana, 47907
Milton Aguirre, PhD, 7654960782, meaguirr@purdue.edu
About this study
Official title: A Scalable Intervention for Stress Management Practices
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.
Read the detailed 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.
- Conditions
- Stress, Diaphragmatic Breathing
- Being tested
- Resistance Breathing Device, Electronic Resistance Breathing Device
- Keywords
- resistance breathing, stress management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Breathing DeviceDevice
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
Electronic Resistance Breathing DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment until completion of 1 hour study period.
Secondary outcomes (2)
Perceived Stress as Measured by the Perceived Stress Scale (PSS_10)
The Perceived Stress Scale is a measure used to assess perceptions of recent stress. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: From enrollment to the end of the 1 hour study period
Physiological Stress as Assessed with Heart Rate Monitoring
Measured: From study enrollment to end of 1 hour study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Aug 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Livotion, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue University, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127575
- Sponsor's protocol ID
- IRB-2025-935
- Other IDs
- 1R41AT012854-01
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scalable Intervention for Stress Management Practices
- ClinicalTrials.gov ID
- NCT07127575
- Acronym / sponsor ID
- IRB-2025-935
- Conditions
- Stress, Diaphragmatic Breathing
- Keywords
- resistance breathing, stress management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Livotion, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Purdue University, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Base AIRpen | Experimental | Device: Resistance Breathing DeviceIn 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. |
| Smart AIRpen | Experimental | Device: Electronic Resistance Breathing DeviceIn 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. |
| 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Breathing DeviceThe 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 | Device | Base AIRpen |
| Electronic Resistance Breathing DeviceThe 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. | Device | Smart AIRpen |
Primary outcome
Device Acceptability as Measured by the Acceptability of Intervention Measure (AIM)
Time frame: From enrollment to end of 1 hour study period.
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.
Device Usability as Measured by a Modified Version of the System Usability Scale (SUS)
Time frame: From enrollment until completion of 1 hour study period.
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.
2 secondary outcomes
Perceived Stress as Measured by the Perceived Stress Scale (PSS_10)
Time frame: From enrollment to the end of the 1 hour study period
Physiological Stress as Assessed with Heart Rate Monitoring
Time frame: From study enrollment to end of 1 hour study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Case, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Breathing Device and Electronic Resistance Breathing Device in people with Stress and Diaphragmatic Breathing, run by Livotion, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milton E Aguirre, PhD (7654960782, meaguirr@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Acceptability as Measured by the Acceptability of Intervention Measure (AIM) (time frame: From enrollment to end of 1 hour study period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.