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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIOV System
Standard Oxygen Cannula
Sponsored by
Breathe Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allegheny General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NIOV System

Standard Oxygen Therapy

Arm Description

Noninvasive ventilation and oxygen delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder

Supplemental oxygen using standard oxygen cannula connected to a portable oxygen cylinder.

Outcomes

Primary Outcome Measures

Activity Endurance Time
Time in minutes of sustained activity while using test treatments

Secondary Outcome Measures

Arterial Oxygen Saturation
O2 saturation measured by pulse oximetry
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

Full Information

First Posted
May 3, 2011
Last Updated
August 17, 2016
Sponsor
Breathe Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01347931
Brief Title
In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency
Official Title
In-home Evaluation of the Breathe Technologies Noninvasive Open Ventilation (NIOV™) System in Patients With Severe Respiratory Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Breathe Technologies, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Airflow Obstruction, Chronic, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIOV System
Arm Type
Experimental
Arm Description
Noninvasive ventilation and oxygen delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder
Arm Title
Standard Oxygen Therapy
Arm Type
Active Comparator
Arm Description
Supplemental oxygen using standard oxygen cannula connected to a portable oxygen cylinder.
Intervention Type
Device
Intervention Name(s)
NIOV System
Other Intervention Name(s)
NIOV, Oxygen, O2
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Oxygen Cannula
Other Intervention Name(s)
Cannula
Intervention Description
Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder
Primary Outcome Measure Information:
Title
Activity Endurance Time
Description
Time in minutes of sustained activity while using test treatments
Time Frame
Measured during single day study visit
Secondary Outcome Measure Information:
Title
Arterial Oxygen Saturation
Description
O2 saturation measured by pulse oximetry
Time Frame
Measured during activity testing in a single day study visit
Title
Borg Dyspnea Score
Description
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
Time Frame
Measured during activity testing in a single day study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian W Carlin, MD
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

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

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