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

Study Overview
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Brief Summary
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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
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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.

Official Title
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In-home Evaluation of the Breathe Technologies Noninvasive Open Ventilation (NIOV™) System in Patients With Severe Respiratory Insufficiency

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

Intervention / Treatment
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* Device: NIOV System
* Device: Standard Oxygen Cannula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIOV System<br>Noninvasive ventilation and oxygen delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder | Device: NIOV System<br>* Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.<br>* Other names: O2;|
| Active Comparator: Standard Oxygen Therapy<br>Supplemental oxygen using standard oxygen cannula connected to a portable oxygen cylinder. | Device: Standard Oxygen Cannula<br>* Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder<br>* Other names: Cannula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity Endurance Time | Time in minutes of sustained activity while using test treatments | Measured during single day study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Oxygen Saturation | O2 saturation measured by pulse oximetry | Measured during activity testing in a single day study visit | 
| Borg Dyspnea Score | 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 | Measured during activity testing in a single day study visit |