Device-guided Breathing for Shortness of Breath in COPD

Study Overview
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Brief Summary
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Although drug therapies and pulmonary rehabilitation have greatly improved COPD symptoms, as many as 50% of patients with severe COPD have inadequately controlled dyspnea. Device-guided breathing is a behavioral intervention that guides respiratory rates into a therapeutic range; prolongation of the expiratory phase improves hyperinflation, the most significant driver of dyspnea in this population. Device-guided breathing, has no known side-effects, and may represent a cost effective adjunctive treatment for dyspnea in severe COPD.

Official Title
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Device-guided Slow Breathing in COPD Patients With Clinically Significant Dyspnea: Phase 2

Conditions
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COPD, Dyspnea, Hyperinflation

Intervention / Treatment
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* Behavioral: Twice daily practice of device-guided slow breathing.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current or former cigarette smokers of at least 10 pack-years Clinically significant dyspnea, as determined by a score of at least 2 on the Medical Research Council Dyspnea Score questionnaire (0-4), or through pulmonary function test results of a residual volume (RV) of > 150% predicted or an FEV1 of <65% predicted Clinical diagnosis of chronic obstructive pulmonary disease Exclusion Criteria: Unable to use the slow-breathing device due to hearing impairment Poor motivation or lack of interest in using the device Pulmonary Rehabilitation ordered as a new therapy at the time of enrollment

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device-guided slow breathing<br> | Behavioral: Twice daily practice of device-guided slow breathing.<br>* Participants are asked to use the slow-breathing device for 20 minutes twice daily, for 8 weeks. Participants receive weekly telephone calls to monitor device use and are encouraged to use pursed-lips when following the breathing tones of the device while exhaling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine effect of increased device-guided breathing on health-related quality of life measures. | Pre and post device use measures of dyspnea, health-related quality of life, stress, adn self-efficacy for managing chronic disease will be obtained through self-administered questionnaires. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate effect of device-guided slow breathing on daily physical activity. | Evaluate the effect of a higher intensity of device-guided breathing (20 minutes twice daily for 8 weeks) on daily physical activity, as measured by a gold-standard activity monitor, before and after device use. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Biofeedback, Dyspnea, Quality of life, Stress