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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01347931
Recruitment Status : Completed
First Posted : May 5, 2011
Results First Posted : October 11, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pulmonary Disease, Chronic Obstructive
Airflow Obstruction, Chronic
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Interventions: Device: NIOV System
Device: Standard Oxygen Cannula

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Oxygen Therapy

Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.

Breathe 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.


Participant Flow for 2 periods

Period 1:   Standard Oxygen Therapy
    Standard Oxygen Therapy
STARTED   30 
COMPLETED   29 
NOT COMPLETED   1 
Withdrawal by Subject                1 

Period 2:   NIOV System
    Standard Oxygen Therapy
STARTED   29 
COMPLETED   29 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per protocol

Reporting Groups
  Description
Overall Study Group All subjects participating in 2-way crossover design study

Baseline Measures
   Overall Study Group 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Mean (Standard Deviation)
 72  (6.3) 
Gender 
[Units: Participants]
 
Female   18 
Male   12 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   4 
White   26 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   30 


  Outcome Measures

1.  Primary:   Activity Endurance Time   [ Time Frame: Measured during single day study visit ]

2.  Secondary:   Arterial Oxygen Saturation   [ Time Frame: Measured during activity testing in a single day study visit ]

3.  Secondary:   Borg Dyspnea Score   [ Time Frame: Measured during activity testing in a single day study visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Richard J. Morishige, MS, RRT
Organization: Clinical Reseach Consulting
phone: 510-606-0375
e-mail: rjmorishige@gmail.com



Responsible Party: Breathe Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01347931     History of Changes
Other Study ID Numbers: CP-00-0034
First Submitted: May 3, 2011
First Posted: May 5, 2011
Results First Submitted: March 8, 2015
Results First Posted: October 11, 2016
Last Update Posted: October 11, 2016