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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Activity Endurance Time
Time in minutes of sustained activity while using test treatments
Time frame: Measured during single day study visit
Arterial Oxygen Saturation
O2 saturation measured by pulse oximetry
Time frame: 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
Time frame: Measured during activity testing in a single day study visit
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