Device-guided Breathing for Shortness of Breath in COPD

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286181
• Other study ID #: 10-008433
• Status: Completed
• Phase: N/A
• First received: January 26, 2011
• Last updated: April 1, 2013
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Dyspnea
• Hyperinflation

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No