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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 3, 2011
Last Updated Date	April 20, 2012
Start Date ^ICMJE	May 2011
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 4, 2011)	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)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01347931 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 4, 2011)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency
Official Title ^ICMJE	In-home Evaluation of the Breathe Technologies Noninvasive Open Ventilation (NIOV™) System in Patients With Severe Respiratory Insufficiency
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pulmonary Disease, Chronic Obstructive Airflow Obstruction, Chronic Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Intervention ^ICMJE	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
Study Arm (s)	Active Comparator: Standard Oxygen Therapy Intervention: Device: Breathe NIOV System Experimental: Breathe NIOV System Intervention: Device: Breathe NIOV System
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	March 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	21 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01347931
Other Study ID Numbers ^ICMJE	CP-00-0034
Has Data Monitoring Committee	No
Responsible Party	Breathe Technologies, Inc.
Study Sponsor ^ICMJE	Breathe Technologies, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Breathe Technologies, Inc.
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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