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

NCT06920407 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-13

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Paul Macey, PhD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2026-09-01
Completion
2027-01-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06920407 on ClinicalTrials.gov