In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency

Not Applicable

Completed

Conditions: Chronic Obstructive Airway Disease
Airflow Obstruction, Chronic
Pulmonary Disease, Chronic Obstructive
Chronic Obstructive Lung Disease

Brief Summary: The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted ventilation, and a comfortable low-profile device, will result in a mean improvement in perceived well-being and ability to perform ADLs, as measured by patient-reported outcome (PRO) instruments.

Detailed Description: This will be a prospective, open-label, crossover study in up to 12 stable subjects with chronic respiratory insufficiency who require LTOT. Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator system during selected activities of daily living. Subjects will participate in the study for up to 9 home visits, with Visits 1 and 2 each lasting for approximately 4 hours, and Visits 3-9 lasting approximately 1-2 hours each. Subjects may discontinue study participation at any time.

Recruitment & Eligibility

Inclusion Criteria

Adult male and female subjects, 21-80 years of age
Diagnosis of chronic respiratory insufficiency including COPD and interstitial lung disease
Requires use of continuous nasal oxygen of at least 2 lpm
Reports limitation of activity due to fatigue or breathlessness
Fluent in written and spoken English language
Ability to be properly fitted with the Breathe nasal mask
Ability to tolerate and be appropriately titrated on the Breathe ventilator
Ability to communicate self-assessment of dyspnea, comfort, and fatigue
Ability and willingness to participate in the study including walking and other activities of daily living
Ability to provide written informed consent

Exclusion Criteria

Recent history of frequent or severe epistaxis
Symptoms of acute respiratory exacerbation within 48 hours of Study Day 1
Discharge from the hospital within 30 days of study enrollment
Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment or who are unlikely to be able to comply with trial requirements
Subjects with conditions that, in the Investigator's opinion, contraindicates study participation

Arm && Interventions

Group	Intervention	Description
Standard Oxygen Therapy	Standard Oxygen Cannula	Supplemental oxygen using standard oxygen cannula connected to a portable oxygen cylinder.
NIOV System	NIOV System	Noninvasive ventilation and oxygen delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder

Primary Outcome Measures

Name	Time	Method
Activity Endurance Time	Measured during single day study visit	Time in minutes of sustained activity while using test treatments

Secondary Outcome Measures

Name	Time	Method
Borg Dyspnea Score	Measured during activity testing in a single day study visit	Borg Dyspnea score is measured using a 11-point visual analog scale. The lower the score on the scale, the less breathlessness patient experiences. The score ranges from: 0 = No breathlessness at all, representing better outcome 10 = Maximum, representing worse outcome
Arterial Oxygen Saturation	Measured during activity testing in a single day study visit	O2 saturation measured by pulse oximetry