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Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients | Clinical Trials | Clareo Health

COMPLETEDNA

Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients

Pilot Study to Assess the Effect of Providing Intermittent Positive Airway Pressure in COPD Patients in Order to Relieve Their Exertion Related Shortness of Breath

NCT03349437•Philips Respironics

View on ClinicalTrials.gov

Summary

Dyspnea is the most common symptom limiting the ability of COPD patients to perform activities of daily living. Although there has been research involving the benefit of providing Non Invasive Ventilation (NIV) during exercise to increase tolerance overall, there is little research specifically looking at shortening dyspnea recovery times associated with exercise. We hypothesize that providing intermittent non-invasive positive pressure therapy (a form of NIV or PAP) with a handheld device to COPD patients immediately after exertion can relieve their dyspnea, and consequently allow them to be more active. In this study, we are comparing the distance walked as measured by a modified 6-Minute Walk Test (6MWT) of 20 COPD patients using VitaBreath (NIV) device versus Pursed Lip Breathing.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 40
•Ability to provide consent
•COPD diagnosis
•Forced Expiratory Volume in one second (FEV1) \<55 and ≥ 25 percent of predicted value
•Perceived Shortness of Breath via the Modified Medical Research Counsel Dyspnea questionnaire (rating of 2 or greater) (Appendix B)
•Able to follow directions
•Able to tolerate mild physical activity
•Pursed Lip Breathing as standard of care
•No evidence of bullous lung disease (with any bullae greater than 3cm in diameter) as confirmed by a CT scan within the past one year.

Exclusion Criteria

•Subjects who are acutely ill, medically complicated or who are medically unstable as determined by the investigator.
•Suffering from COPD exacerbation at time of enrollment or 60 days prior
•Subjects who are not currently prescribed oxygen and manifest oxygen desaturation below 88% on the screening 6MWT
•Subjects with heart disease or neuromuscular disease.
•Subjects who are not prescribed short-acting bronchodilator medication
•Patients who have experienced recent barotrauma or pneumothorax
•Unstable angina or Myocardial Infarction during past month
•Uncontrolled Hypertension (systolic blood pressure of \>180mmHg (millimeters of Mercury) and a diastolic \>100mmHg)
•Heart Rate \>120 at rest
•Subjects who have trouble coordinating their breathing with the device during the device training, or cannot tolerate the device mouthpiece resulting in leaks from the nasal cavity
+1 more criteria

Locations (2)

Pullmonary Rehabilition Associates

Youngstown, Ohio, United States

Pittsburgh Pulmonary Associates

Jefferson Hills, Pennsylvania, United States

Key Dates

Start Date

November 6, 2017

Primary Completion Date

February 20, 2018

Completion Date

February 20, 2018

Last Updated

May 8, 2019

Enrollment

ACTUAL participants

Conditions

COPDDyspnea

Interventions

Vitabreath Device

DEVICE

Pursed Lip Breathing

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

Effect of Telenursing on Oral Health

Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

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