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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: August 17, 2016
Last verified: August 2016

May 3, 2011
August 17, 2016
May 2011
March 2012   (final data collection date for primary outcome measure)
Activity Endurance Time [ Time Frame: Measured during single day study visit ] [ Designated as safety issue: No ]
Time in minutes of sustained activity while using test treatments
  • 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)
Complete list of historical versions of study NCT01347931 on ClinicalTrials.gov Archive Site
  • Arterial Oxygen Saturation [ Time Frame: Measured during activity testing in a single day study visit ] [ Designated as safety issue: No ]
    O2 saturation measured by pulse oximetry
  • Borg Dyspnea Score [ Time Frame: Measured during activity testing in a single day study visit ] [ Designated as safety issue: No ]

    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

  • 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
Not Provided
Not Provided
 
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.
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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Disease, Chronic Obstructive
  • Airflow Obstruction, Chronic
  • Chronic Obstructive Airway Disease
  • Chronic Obstructive Lung Disease
  • 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:
    • NIOV
    • Oxygen
    • O2
  • Device: Standard Oxygen Cannula
    Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder
    Other Name: Cannula
  • Experimental: NIOV System
    Noninvasive ventilation and oxygen delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder
    Intervention: Device: NIOV System
  • Active Comparator: Standard Oxygen Therapy
    Supplemental oxygen using standard oxygen cannula connected to a portable oxygen cylinder.
    Intervention: Device: Standard Oxygen Cannula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
21 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01347931
CP-00-0034
No
Not Provided
Not Provided
Breathe Technologies, Inc.
Breathe Technologies, Inc.
Not Provided
Principal Investigator: Brian W Carlin, MD West Penn Allegheny Health System
Breathe Technologies, Inc.
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP