ClinicalTrials.gg
Enrolling by invitationNCT06920407Updated Sep 22, 2026

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

An interventional study of Breathing training device (Inspiratory Muscle Training) and Oura Ring in Healthy, sponsored by University of California, Los Angeles. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Prevention

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Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 17 studies in Psychological Well-Being by University of California, Los Angeles — 5 open to participants now, 5 under way, none of them phase 3. Psychological Well-Being · University of California, Los Angeles.

Planned enrollment
12th of 16
150 · median 430
Started
2025
with 2 others
No phase
15 of 17
4 open now
Registered
12th of 17
by date

Among the 17 studies in Psychological Well-Being by University of California, Los Angeles, this one is the 12th largest by planned enrollment of the 16 interventional ones that give a count, is one of 3 that started in 2025, is one of 15 with no phase, and was the 12th registered.

Psychological Well-Being

2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.

Browse Psychological Well-Being studies →

Open to participants now

5 of the 17 studies in Psychological Well-Being by University of California, Los Angeles are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies in Psychological Well-Being by University of California, Los Angeles, or all of them as a file.
02

Study summary

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.
Read the detailed description

This study seeks to investigate the impact of daily inspiratory muscle training (IMT) over 12 weeks on mental and physical well-being, focusing on whether the effects are sustained three months post-intervention. IMT is a breathing exercise known to improve respiratory function and reduce stress. This research will expand on previous findings showing that IMT can influence psychological states, such as increased awareness of the body, and improved relaxation and well-being. The investigators aim to compare the effects of IMT against a sham IMT group and a health data engagement-only group, assessing whether daily IMT enhances psychological well-being, body awareness, and physical relaxation.

Study Design and Groups:

  • IMT Group: Participants will engage in daily inspiratory muscle training with the Powerbreathe device at moderate to high resistance, aimed at improving respiratory strength and exploring the effects of higher resistance training on well-being.
  • Sham IMT Group: This group will complete daily IMT sessions at low resistance. This type of training encourages slower, deeper breaths, which some participants have found to help with relaxation and improving breath control.
  • Engagement-Only Group: Participants will wear the Oura ring, which tracks health metrics such as heart rate, sleep, and physical activity. They will engage with the app to sync their data and review personal insights, fostering health awareness and self-monitoring.

Key Outcome Measures:

  • Psychological Well-Being: Evaluated using the NIH Toolbox Psychological Well-Being (PWB) test.
  • Body Awareness: Assessed with the Multidimensional Assessment of -Interoceptive Awareness (MAIA) scale.
  • Physical Relaxation: Measured by heart rate variability (RMSSD), which reflects vagal tone and overall relaxation.

Study Procedures:

Participants will complete their assigned interventions for 12 weeks, with data collection at baseline, post-intervention (12 weeks), and at a 3-month follow-up. All participants will be asked to engage with weekly surveys to track their mental and physical health. The study also measures adherence, age, gender, physical activity, and sleep quality as potential confounding factors to better understand the broader impacts of the interventions.

This study aims to compare the effects of IMT at different resistance levels to see if it improves well-being, whether these benefits are maintained over time, and how it compares to simply engaging with health-tracking data.

03

Conditions studied

  • Healthy

Keywords

  • Breathing
  • Stress
  • Breathing Training
  • Inspiratory Muscle Training
  • Breathing resistance training
  • Interoception
  • Physical and mental well-being
  • Health tracking
  • Oura
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 or higher
  • Stable health for the past 3 months.

Exclusion criteria

Exclusion Criteria:

  • IMT which relate to people who should not raise lung, thoracic, or sinus pressures
  • Current or recent (\< 3 months) use of cardiovascular or psychotropic medications
  • Diagnosed psychotic disorders
  • Current participation in therapy
  • Recent initiation of mind-body practice
  • Current major illness or injury
  • Regular use of personal tracking devices to monitor sleep, heart rate, activity, or related physiological data.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    IMT

    Participants 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.

    Device: Breathing training device (Inspiratory Muscle Training) · Device: Oura Ring

  • Sham comparator
    IMT Sham

    Participants 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.

    Device: Breathing training device (Inspiratory Muscle Training) · Device: Oura Ring

  • Active comparator
    Control

    Participants 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.

    Device: Oura Ring

Interventions

  • DeviceBreathing training device (Inspiratory Muscle Training)

    Daily 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.

    Also known as: Powerbreathe IMT K3 device

  • DeviceOura Ring

    The 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.

    Also known as: biometric ring

06

What researchers measure

Primary outcomes

  1. Change in Psychological Well-Being

    Psychological well-being will be assessed using the NIH Toolbox Psychological Well-Being Scale. This instrument evaluates life satisfaction, positive emotions, and sense of purpose. Higher scores indicate greater psychological well-being. Unit of Measure: Standardized scale score

    Time frame: From enrollment to the completion of the 12-week intervention period, followed by the observational period extending until week 24.

  2. Change in Body Awareness

    Body awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA), a validated questionnaire examining emotional awareness, body listening, and self-regulation. Higher scores indicate greater interoceptive awareness. Unit of Measure: Questionnaire scale score

    Time frame: From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24.

  3. Change in Heart Rate Variability (HRV)

    Heart rate variability will be assessed using the Root Mean Square of Successive Differences (RMSSD), reported in milliseconds. RMSSD reflects parasympathetic nervous system activity, with higher values indicating greater physiological relaxation. Unit of Measure: Milliseconds (ms)

    Time frame: From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24.

  4. Change in Inspiratory Muscle Strength

    Inspiratory muscle strength will be measured using the PowerBreathe training device and reported in centimeters of water pressure (cmH₂O), representing the pressure generated during inhalation against resistance. Unit of Measure: cmH₂O

    Time frame: From enrollment (first physiology visit) to the end of the 12-week intervention period.

  5. Change in Peak Inspiratory Flow Rate

    Peak inspiratory flow rate will be measured using the PowerBreathe training device and recorded in liters per minute (L/min), indicating the maximum airflow achieved during inhalation. Unit of Measure: Liters per minute (L/min)

    Time frame: From enrollment (first physiology visit) to the end of the 12-week intervention period.

  6. Change in Inhaled Volume per Breath

    Inhaled volume per breath will be assessed using the PowerBreathe training device and measured in milliliters (mL), indicating changes in lung capacity throughout the intervention. Unit of Measure: Milliliters (mL)

    Time frame: From enrollment (first physiology visit) to the end of the 12-week intervention period.

07

Study locations

1 site
  • UCLA School of Nursing, Factor Bldg, 700 Tiverton Dr
    Los Angeles, California 90095, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Apr 2027, 19 months after the start.

Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 19 months is above that.

Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2024
First posted
Apr 9, 2025
StartActual
Aug 26, 2025
Primary completionEst.
Apr 1, 2027
CompletionEst.
Apr 1, 2027
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06920407
Responsible party
Paul Macey, PhD (Principal Investigator, University of California, Los Angeles) — Principal investigator
First posted
Apr 9, 2025
Start date
Aug 26, 2025
Primary completion
Apr 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Paul Macey, PhD
principal investigator · Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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