Vitabreath Pilot in Chronic Obstructive Pulmonary Disease (COPD) Patients
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|ClinicalTrials.gov Identifier: NCT03349437|
Recruitment Status : Completed
First Posted : November 21, 2017
Results First Posted : April 16, 2019
Last Update Posted : May 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|COPD Dyspnea||Device: Vitabreath Device Other: Pursed Lip Breathing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Participants will receive two different interventions after exertion.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 6, 2017|
|Actual Primary Completion Date :||February 20, 2018|
|Actual Study Completion Date :||February 20, 2018|
Experimental: Vitabreath Device
The Philips Respironics investigational device VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support. Pressure support is defined as the difference between inhalation pressure and exhalation pressure. The study device is intended as an adjunct therapy to relieve shortness of breath in COPD patients who experience exertion-related dyspnea to allow them to be more active. The air is delivered to the patient via a mouthpiece on the device.
Device: Vitabreath Device
The VitaBreath device is designed for non-continuous use only and typical device use is expected to be for 2-3 minutes. The device should only be operated for less than 10 minutes at a time. After such time, the device should be turned off for at least 30 minutes
Active Comparator: Pursed Lip Breathing
Pursed lip breathing is a commonly used technique by COPD patients. That involves exhaling through tightly pressed lips and inhaling through the nose with the mouth closed.
Other: Pursed Lip Breathing
Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator.
- Average Distance During Modified 6 Minute Walk Test [ Time Frame: 15 minutes ]Compare the average distance walked during modified 6 minute walk test (M 6MWT) by COPD participants using Pursed Lip Breathing (PLB) versus an intermittent positive airway pressure handheld device, VitaBreath.
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 ClinicalTrials.gov identifier (NCT number): NCT03349437
|United States, Ohio|
|Pullmonary Rehabilition Associates|
|Youngstown, Ohio, United States, 44512|
|United States, Pennsylvania|
|Pittsburgh Pulmonary Associates|
|Jefferson Hills, Pennsylvania, United States, 15025|