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

NCT06920407 | Enrolling By Invitation

• 2 other identifiers: IRB #23-00117720233469
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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)

  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

  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)

  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)

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

Study Arms (3)

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.

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.

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.

Device: Oura Ring

Interventions

Breathing training device (Inspiratory Muscle Training) 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.

Also known as: Powerbreathe IMT K3 device

IMT; IMT Sham

Oura Ring 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.

Also known as: biometric ring

Control; IMT; IMT Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA School of Nursing, Factor Bldg, 700 Tiverton Dr

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration; Psychological Well-Being

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Paul Macey, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: April 9, 2025
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

US (1)