StressNCT07187349
Real World Assessment of Resistance Breathing Device
An observational study of Stress and Breathing Exercise, run by Livotion, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Breathing Exercise, Stress Management
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 5 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Undergradute students from Purdue University
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 2-week long study involving survey completion, training, and AIRpen utilization during an academic examination period
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Scalable Intervention for Stress Management Real World Assessment
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?
Read the 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
- Keywords
- Stress management, Resistance breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Undergraduate Exam Takers | College undergraduate students between the ages of 18-30 who will be involved in an academic examination period at Purdue University. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 study enrollment to the end of the study at 2 weeks.
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 study enrollment to the end of the study at 2 weeks.
Device Feasibility as Measured by the Feasibility of Intervention Measure (FIM)
The Feasibility of Intervention Measure (FIM) measures the feasibility of an intervention through a 5-point Likert scale, and has been adapted in relation to the AIRpen. Statements relate to the overall feasibility of the intervention, with 1 indicating "Completely disagree" while 5 indicates (Completely agree), with a higher score indicating greater feasibility.
Measured: From study enrollment until the end of the study at 2 weeks.
Secondary outcomes (2)
Problem-Focused Coping as Measured by the Coping Self-Efficacy Scale (CSES)
The Coping Self-Efficacy Scale (CSES) measures an individual's degree of confidence that s/he can perform coping behaviors when faced with life challenges. The CSES consists of three subscales measuring Problem-focused Coping, Emotion-focused Coping, and Social Support Coping. The CSES is administered as a 26-item form, although for this study only the Problem-Focused Coping subscale is administered from 0 to 10. Scoring higher on problem-focused coping self-efficacy means an individual has a strong belief in their ability to actively manage, reduce, or eliminate the root cause of a stressor
Measured: From study enrollment to the end of the study at 2 weeks
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 Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: From study enrollment to the end of the study at 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Dec 2025
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
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
- NCT07187349
- Sponsor's protocol ID
- IRB-2025-13
- Other IDs
- 1R41AT012854-01
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2025
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scalable Intervention for Stress Management Real World Assessment
- ClinicalTrials.gov ID
- NCT07187349
- Acronym / sponsor ID
- IRB-2025-13
- Conditions
- Stress, Breathing Exercise, Stress Management
- Keywords
- Stress management, Resistance breathing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Livotion, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Purdue University, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 23 Sep 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undergraduate Exam Takers | – | –College undergraduate students between the ages of 18-30 who will be involved in an academic examination period at Purdue University. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Undergradute students from Purdue University
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 2-week long study involving survey completion, training, and AIRpen utilization during an academic examination period
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device Usability as Measured by a Modified Version of the System Usability Scale (SUS)
Time frame: From study enrollment to the end of the study at 2 weeks.
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.
Device Acceptability as Measured by the Acceptability of Intervention Measure (AIM)
Time frame: From study enrollment to the end of the study at 2 weeks.
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 Feasibility as Measured by the Feasibility of Intervention Measure (FIM)
Time frame: From study enrollment until the end of the study at 2 weeks.
The Feasibility of Intervention Measure (FIM) measures the feasibility of an intervention through a 5-point Likert scale, and has been adapted in relation to the AIRpen. Statements relate to the overall feasibility of the intervention, with 1 indicating "Completely disagree" while 5 indicates (Completely agree), with a higher score indicating greater feasibility.
2 secondary outcomes
Problem-Focused Coping as Measured by the Coping Self-Efficacy Scale (CSES)
Time frame: From study enrollment to the end of the study at 2 weeks
Perceived Stress as Measured by the Perceived Stress Scale (PSS_10)
Time frame: From study enrollment to the end of the study at 2 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Breathing Exercise, 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: finished, as of the sponsor's last update on 13 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Usability as Measured by a Modified Version of the System Usability Scale (SUS) (time frame: From study enrollment to the end of the study at 2 weeks.). The study lists 3 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 13 Apr 2026.