BreatheWell: Train Your Breathing, Relax Your Body, Open Your Mind
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of California, Los Angeles
- Study ID
- NCT06920407
- Status
- Enrolling By Invitation
Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Breathing training device (Inspiratory Muscle Training) — DEVICEDaily inspiratory muscle training (IMT) using the PowerBreathe IMT K3 device at varying resistance levels (15% for Sham and 65% for Experimental group) for 12 weeks. Participants will perform breathing exercises designed to assess the effects of different resistance levels on overall physical and emotional well-being, with a focus on how varying resistance impacts both respiratory strength and well-being.
- Oura Ring — DEVICEThe Oura ring measures daily biometrics such as heart rate, sleep, and blood oxygen levels, providing personalized health data and insights. Participants have access to this data through a mobile app, allowing researchers to assess whether increased access to health data and awareness has an impact on overall physical and emotional well-being.
Study Details
The goal of this study is to determine whether tasks related to breathing training (daily inspiratory muscle training (IMT) and increased access to health data/awareness) performed for 12 weeks leads to positive changes in mental and physical states, and if these changes are sustained three months later. The study will assess whether IMT, compared to a sham IMT and the control group, improves psychological well-being, body awareness, and physical relaxation. Although there is evidence that all three interventions make a difference, the extent of their impact is yet to be determined, so the study aims to compare the effectiveness of the interventions, aiming to determine which may be most beneficial. The main questions the study aims to answer are: * Do tasks related to breathing training (high resistance IMT, low resistance IMT, or access to health data) performed over 12 weeks enhance mental and physical well-being? * Are the changes in mental and physical states sustained three months post-intervention? * Is IMT more effective than sham IMT or simple health data engagement in improving well-being? * Who benefits from each intervention? Participants will be randomly assigned to three groups: * IMT: Daily inspiratory muscle training at a moderate to high resistance. * Sham IMT: Daily inspiratory muscle training at a low resistance. * Control: Participants will track their health data but not engage in IMT. Participants will: * Engage in daily IMT or sham IMT training for 12 weeks. * Engage with the Oura ring and app by checking in daily to sync the ring's data and review personal health insights. * Complete daily and weekly surveys tracking mental and physical health. * Have biometric data collected at baseline, post-intervention (12 weeks), and at a 3-month follow-up.
Key Dates
- Start date
- Aug 26, 2025
- Status verified
- May 2026
- Primary completion
- Sep 1, 2026
- Completion
- Jan 30, 2027
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: IMTParticipants will perform Inspiratory Muscle Training (IMT) using the PowerBreathe IMT K3 device at 65% resistance, focusing on the effects of higher resistance training on respiratory strength, physical well-being, and emotional well-being.
- Sham Comparator: IMT ShamParticipants will perform the IMT procedure using the PowerBreathe IMT K3 device at 15% resistance to assess the effects of lower resistance on overall physical and emotional well-being, compared to higher resistance training.
- Active Comparator: ControlParticipants will not undergo the IMT procedure and will instead receive general health awareness through the Oura ring (a biometric ring and app), serving as the baseline group for comparison.
Primary Outcome Measure
Change in Psychological Well-Being [ Time Frame: From enrollment to the completion of the 12-week intervention period, followed by the observational period extending until week 24. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCLA School of Nursing, Factor Bldg, 700 Tiverton Dr | Los Angeles | California | 90095 | - |
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