Phase 3
N=10
Validation of the AVAPS AE Algorithm in Chronic Obstructive Pulmonary Disease (COPD) Patients
COPD · OSA
Bottom Line
View on ClinicalTrials.gov: NCT01601977 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Control of Nocturnal Hypoventilation — 6.5; 6.7 kPa
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AVAPS-AE (Device); Usual care (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Patrick Murphy
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Control of Nocturnal Hypoventilation |
6.4; 6.5 | — |
| SECONDARY Health Related Quality of Life |
61; 59 | — |
| SECONDARY Health Related Quality of Life |
61; 59 | — |
| SECONDARY Total Sleep Time |
330; 306 | — |
| SECONDARY Control of Nocturnal Hypoventilation |
6.4; 6.5 | — |
| SECONDARY Exercise Capacity |
190; 175 | — |
| SECONDARY Exacerbation Frequency |
0; 0 | — |
Summary
COPD continues to be a cause of major morbidity for patients. Those patients who also have respiratory failure and obstructive sleep apnoea are at higher risk of exacerbations and death and have worse health related quality of life than similar COPD patients without respiratory failure.
Treatment options in this group of patients have been limited and data to support the use of machines to assist breathing (non-invasive ventilators) in stable patients are limited. A major limitation of these devices has been patient acceptance and achieving sufficient control of sleep breathing disturbance.
Currently devices are set at a fixed pressure to support the breathing throughout the night. The new software within the trial device will aim to better match the support provided by the machine to that needed by the patient. It is hoped that this may offer enhanced comfort as well as superior control of respiratory failure.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 21
- Diagnosis of COPD
- Currently using Bilevel device for COPD-OSA overlap syndrome
- Ability to provide consent
- Documentation of medical stability by PI
Exclusion Criteria
- Subjects, who are acutely ill, medically complicated or who are medically unstable.
- Subjects in whom PAP therapy is otherwise medically contraindicated.
- Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- Subjects with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLMI > 10).
Data sourced from ClinicalTrials.gov (NCT01601977). 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.