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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Breathe Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01347931
First received: May 3, 2011
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Airflow Obstruction, Chronic
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Device: Breathe NIOV System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In-home Evaluation of the Breathe Technologies Noninvasive Open Ventilation (NIOV™) System in Patients With Severe Respiratory Insufficiency

Resource links provided by NLM:


Further study details as provided by Breathe Technologies, Inc.:

Primary Outcome Measures:
  • Dyspnea Score [ Time Frame: Periodically over four hours ] [ Designated as safety issue: No ]
    Borg Dyspnea Score (BDS)

  • Fatigue Score [ Time Frame: Periodically over four hours ] [ Designated as safety issue: No ]
    Fatigue Visual Analogue Scale (VAS)

  • Comfort Score [ Time Frame: Periodically over four hours ] [ Designated as safety issue: No ]
    Comfort Visual Analog Scale (VAS)


Secondary Outcome Measures:
  • Heart rate [ Time Frame: Up to four hours each study visit ] [ Designated as safety issue: No ]
  • Respiratory rate [ Time Frame: Up to four hours each study visit ] [ Designated as safety issue: No ]
  • Oxygen saturation [ Time Frame: Up to four hours each study visit ] [ Designated as safety issue: No ]
    Pulse oximetry

  • Partial pressure of carbon dioxide measured transcutaneously (TcPCO2) [ Time Frame: Periodically over four hours ] [ Designated as safety issue: No ]
  • Actigraphy [ Time Frame: Up to four hours each study visit ] [ Designated as safety issue: No ]
    Actigraphy monitor

  • Quality of Life (QOL) [ Time Frame: Before intervention begins on the first study day (baseline); at the completion of the first study day; at the completion of study days 2-9. ] [ Designated as safety issue: No ]
    Chronic Respiratory Questionnaire


Enrollment: 30
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Oxygen Therapy Device: Breathe NIOV System
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.
Other Names:
  • NIOV
  • Oxygen
  • O2
Experimental: Breathe NIOV System Device: Breathe NIOV System
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.
Other Names:
  • NIOV
  • Oxygen
  • O2

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347931

Locations
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Breathe Technologies, Inc.
  More Information

No publications provided

Responsible Party: Breathe Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01347931     History of Changes
Other Study ID Numbers: CP-00-0034
Study First Received: May 3, 2011
Last Updated: April 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Lung Diseases, Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Respiration Disorders

ClinicalTrials.gov processed this record on September 22, 2014