Device-guided Breathing for Shortness of Breath in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01286181
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : April 4, 2013
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COPD Dyspnea Hyperinflation Behavioral: Twice daily practice of device-guided slow breathing. Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Device-guided Slow Breathing in COPD Patients With Clinically Significant Dyspnea: Phase 2
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Device-guided slow breathing Behavioral: Twice daily practice of device-guided slow breathing.
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.

Primary Outcome Measures :
  1. Determine effect of increased device-guided breathing on health-related quality of life measures. [ Time Frame: 8 weeks ]
    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.

Secondary Outcome Measures :
  1. Evaluate effect of device-guided slow breathing on daily physical activity. [ Time Frame: 8 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01286181

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Roberto Benzo, MD Mayo Clinic

Responsible Party: Roberto P. Benzo, Principal Investigator, Mayo Clinic Identifier: NCT01286181     History of Changes
Other Study ID Numbers: 10-008433
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by Roberto P. Benzo, Mayo Clinic:
Quality of life

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms