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BreatheWell: Train Your Breathing, Relax Your Body, Open Your Mind

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Sep 1, 2026 → Apr 1, 2027
See other at-risk trials from University of California, Los Angeles

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Sep 1, 2026 to Apr 1, 2027
    • Study completion pushed from Jan 30, 2027 to Apr 1, 2027
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 6 words
  2. Notable Start date: Jul 1, 2024 to Aug 26, 2025
    • Primary completion date: Jul 1, 2026 to Sep 1, 2026
    • Study completion date: Jul 1, 2026 to Jan 30, 2027
    v3
  3. Minor Eligibility criteria expanded, about 14 wordsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06920407
Lead Sponsor University of California, Los Angeles
Conditions
(from sponsor)
Healthy
Related terms Psychological Well-Being, Respiratory Aspiration
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov