Completed

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

What is being tested

Twice daily practice of device-guided slow breathing.

Behavioral

Who is being recruted

Chronic Disease+9

+ Dyspnea

+ Lung Diseases

Over 40 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: January 2011

See protocol details

Summary

Principal SponsorMayo Clinic

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2011

Actual date on which the first participant was enrolled.

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 TitleDevice-guided Slow Breathing in COPD Patients With Clinically Significant Dyspnea: Phase 2

NCT01286181

Principal SponsorMayo Clinic

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseDyspneaLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiration DisordersRespiratory Tract DiseasesSigns and SymptomsSigns and Symptoms, RespiratoryPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

Criteria

3 inclusion criteria required to participate

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

3 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Mayo Clinic in Rochester

Rochester, United StatesOpen Mayo Clinic in Rochester in Google Maps

CompletedOne Study Center