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

NCT ID: NCT06920407

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-07-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Breathing training device (Inspiratory Muscle Training)

Intervention Type: 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 Ring

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

Breathing training device (Inspiratory Muscle Training)

Intervention Type: 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 Ring

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Oura Ring

Intervention Type: DEVICE

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.

Interventions

Breathing 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.

Intervention Type: DEVICE

Oura 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.

Intervention Type: DEVICE

Other Intervention Names

Powerbreathe IMT K3 device; biometric ring

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Paul Macey, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Macey, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

UCLA School of Nursing, Factor Bldg, 700 Tiverton Dr

Los Angeles, California, United States

Countries

United States

Other Identifiers

20233469

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB #23-001177

Identifier Type: -

Identifier Source: org_study_id