Scalable Intervention for Stress Management

Part of paid clinical trials in West Lafayette, Indiana.

Sponsor
Livotion, LLC
Study ID
NCT07127575
Status
Recruiting

Conditions

  • Diaphragmatic Breathing
  • Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Accepted

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
  • 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.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Base AIRpen
    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.
  • Experimental: Smart AIRpen
    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.
  • No Intervention: No AIRpen
    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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Purdue UniversityWest LafayetteIndiana47907
Milton Aguirre, PhD
7654960782

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