COPD Clinical Trial
— AVAPS AEOfficial title:
Validation of the AVAPS AE Algorithm in Chronic Obstructive Pulmonary Disease: A Non-randomised Pilot Study
COPD continues to be a cause of major morbidity for patients. Those patients who also have
respiratory failure 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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Age = 21 - Diagnosis of COPD - Currently using Bilevel device - 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). |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Thomas' Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Patrick Murphy | Philips Respironics |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | control of nocturnal hypoventilation | transcutaneous CO2 recording from overnight sleep study whilst using the device at 6 weeks compared to baseline control when using usual device | 6 week assessment | No |
Secondary | Health related quality of life | SRI questionnaire, CAT score, Epworth score, MRC dyspnoea score | 2 weeks | No |
Secondary | Health related quality of life | SRI questionnaire, CAT score, Epworth score, MRC dyspnoea score | 6 weeks | No |
Secondary | Sleep disruption | Full polysomnography performed at baseline (usual device) and 6 weeks (trial device) to examine TST, sleep stage distibution, arousal index, AHI | 6 weeks | No |
Secondary | control of nocturnal hypoventilation | overnight limited respiratory sleep study examining mean SpO2, min SpO2, max tcCO2, 4%ODI | 2 weeks | No |
Secondary | Assessment of nocturnal hypoventilation | overnight limited respiratory sleep study examining mean SpO2, min SpO2, max tcCO2, 4%ODI | 6 weeks | No |
Secondary | Exercise capacity | 6 minute walk test | 6 weeks | No |
Secondary | Exacerbation frequency | patient reported exacerbations following 6 weeks of device usage | 6 weeks | Yes |
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