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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive; Chronic Obstructive Lung Disease; Chronic Obstructive Airway Disease; Airflow Obstruction, Chronic
• Intervention / Treatment: Device: NIOV System; Device: Standard Oxygen Cannula

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NIOV System; Noninvasive ventilation and oxygen delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder	Device: NIOV System; 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.; Other Names: Oxygen; O2; NIOV
Active Comparator: Standard Oxygen Therapy; Supplemental oxygen using standard oxygen cannula connected to a portable oxygen cylinder.	Device: Standard Oxygen Cannula; Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder; Other Names: Cannula

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Breathe Technologies, Inc.
• Investigators: Principal Investigator: Brian W Carlin, MD, West Penn Allegheny Health System

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: May 3, 2011
• First Submitted That Met QC Criteria: May 4, 2011
• First Posted (Estimate): May 5, 2011

Study Record Updates

• Last Update Posted (Estimate): October 11, 2016
• Last Update Submitted That Met QC Criteria: August 17, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency
• Other Study ID Numbers: CP-00-0034