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

University of California, Los Angeles (UCLA)

Status: Invitation-only

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06920407

IRB #23-001177

20233469 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

IMT

Experimental group

Description:

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.

Treatment:

Device: Oura Ring

Device: Breathing training device (Inspiratory Muscle Training)

IMT Sham

Sham Comparator group

Description:

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.

Treatment:

Device: Oura Ring

Device: Breathing training device (Inspiratory Muscle Training)

Control

Active Comparator group

Description:

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.

Treatment:

Device: Oura Ring