NCT03349437

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD
• Dyspnea

Interventions

Type	Name	Description
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
OTHER	Pursed Lip Breathing	Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator.

Timeline

• Start date: 2017-11-06
• Primary completion: 2018-02-20
• Completion: 2018-02-20
• First posted: 2017-11-21
• Last updated: 2019-05-08
• Results posted: 2019-04-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study