Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIOV System | Experimental | Noninvasive ventilation and oxygen delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder |
|
| Standard Oxygen Therapy | Active Comparator | Supplemental oxygen using standard oxygen cannula connected to a portable oxygen cylinder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIOV System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Activity Endurance Time | Time in minutes of sustained activity while using test treatments | Measured during single day study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Oxygen Saturation | O2 saturation measured by pulse oximetry | Measured during activity testing in a single day study visit |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian W Carlin, MD | West Penn Allegheny Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Standard Oxygen Therapy |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard Oxygen Cannula | Device | Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder |
|
|
| Measured during activity testing in a single day study visit |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| NIOV System |
|
Per protocol
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Group | All subjects participating in 2-way crossover design study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Activity Endurance Time | Time in minutes of sustained activity while using test treatments | Per Protocol | Posted | Mean | Standard Deviation | minutes | Measured during single day study visit |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Arterial Oxygen Saturation | O2 saturation measured by pulse oximetry | Per Protocol | Posted | Mean | Standard Deviation | percentage of oxyHb saturation | Measured during activity testing in a single day study visit |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Per Protocol | Posted | Median | 95% Confidence Interval | units on a scale | Measured during activity testing in a single day study visit |
|
|
Continuously monitored during a Single day study visit lasting up to 4 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Oxygen Therapy | Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder. 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. | 0 | 29 | 0 | 29 | ||
| EG001 | Breathe NIOV System | Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder 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. | 0 | 29 | 0 | 29 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard J. Morishige, MS, RRT | Clinical Reseach Consulting | 510-606-0375 | rjmorishige@gmail.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D000072601 | Cannula |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Participants |
|
|