HealthyNCT06920407
BreatheWell: Train Your Breathing, Relax Your Body, Open Your Mind
A study testing Breathing training device (Inspiratory Muscle Training) and Oura Ring in people with Healthy, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Breathing training device (Inspiratory Muscle Training) and Oura Ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or higher
- Stable health for the past 3 months.
Who cannot join
- IMT contraindications 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCLA School of Nursing, Factor Bldg, 700 Tiverton Dr
Los Angeles, California, 90095
About this study
Official title: BreatheWell: Does Breathing Resistance Training Relax the Body and Calm the Mind?
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:
Read more
- 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.
- Conditions
- Healthy
- Being tested
- Breathing training device (Inspiratory Muscle Training), Oura Ring
- Keywords
- Breathing, Stress, Breathing Training, Inspiratory Muscle Training, Breathing resistance training, Interoception, Physical and mental well-being, Health tracking, Oura
- Medical subject headings
- Respiratory Aspiration, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing training device (Inspiratory Muscle Training)Device
Also called Powerbreathe IMT K3 device
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.
Oura RingDevice
Also called biometric 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.
| Study group | Role | What they receive |
|---|---|---|
| IMT | Experimental | 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. Receives: Device: Breathing training device (Inspiratory Muscle Training); Device: Oura Ring |
| IMT Sham | Sham comparator | 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. Receives: Device: Breathing training device (Inspiratory Muscle Training); Device: Oura Ring |
| Control | Active comparator | 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. Receives: Device: Oura Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the completion of the 12-week intervention period, followed by the observational period extending until week 24.
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
Measured: From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24.
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)
Measured: From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24.
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
Measured: From enrollment (first physiology visit) to the end of the 12-week intervention period.
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)
Measured: From enrollment (first physiology visit) to the end of the 12-week intervention period.
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)
Measured: From enrollment (first physiology visit) to the end of the 12-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start26 Aug 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Macey, PhD, University of California, Los Angeles
- Investigators
- Paul Macey, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920407
- Sponsor's protocol ID
- IRB #23-001177
- Other IDs
- 20233469
- Status last verified
- May 2026
- First submitted
- 8 Jul 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BreatheWell: Does Breathing Resistance Training Relax the Body and Calm the Mind?
- ClinicalTrials.gov ID
- NCT06920407
- Acronym / sponsor ID
- IRB #23-001177
- Conditions
- Healthy
- Keywords
- Breathing, Stress, Breathing Training, Inspiratory Muscle Training, Breathing resistance training, Interoception, Physical and mental well-being, Health tracking
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 9 Apr 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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMT | Experimental | Device: Breathing training device (Inspiratory Muscle Training), Device: Oura RingParticipants 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. |
| IMT Sham | Sham comparator | Device: Breathing training device (Inspiratory Muscle Training), Device: Oura RingParticipants 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. |
| Control | Active comparator | Device: Oura RingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or higher
- Stable health for the past 3 months.
Key exclusion criteria (7 listed)
- IMT contraindications 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing training device (Inspiratory Muscle Training)Also: Powerbreathe IMT K3 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. | Device | IMT, IMT Sham |
| Oura RingAlso: biometric ringThe 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. | Device | Control, IMT, IMT Sham |
Primary outcome
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.
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
Change in Body Awareness
Time frame: From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24.
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
Change in Heart Rate Variability (HRV)
Time frame: From enrollment to the end of the 12-week intervention period, followed by an observational period through week 24.
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)
Change in Inspiratory Muscle Strength
Time frame: From enrollment (first physiology visit) to the end of the 12-week intervention period.
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
Change in Peak Inspiratory Flow Rate
Time frame: From enrollment (first physiology visit) to the end of the 12-week intervention period.
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)
Change in Inhaled Volume per Breath
Time frame: From enrollment (first physiology visit) to the end of the 12-week intervention period.
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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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.
Paul Macey, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing training device (Inspiratory Muscle Training) and Oura Ring in people with Healthy, run by University of California, Los Angeles 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 2 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 22 Sep 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
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.). The study lists 6 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 22 Sep 2026.