N/A
Completed N=30
In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency
Pulmonary Disease, Chronic Obstructive · Airflow Obstruction, Chronic · Chronic Obstructive Airway Disease · Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT01347931 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Activity Endurance Time — 7.24; 13.38 minutes — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Activity Endurance Time |
7.24; 13.38 | <0.05 sig |
| SECONDARY Arterial Oxygen Saturation |
90.65; 94.78 | <0.05 sig |
| SECONDARY Borg Dyspnea Score |
3; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01347931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.