Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.
Full description
Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patients aged 18-80 years
- Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
- Patients who are using ResMed masks
Exclusion criteria
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Patients who are unable to provide written informed consent
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Patients who are unable to comprehend written and spoken English
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Patients who are using Bilevel PAP
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Patients who are pregnant
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Patients who are suffering any of the following:
- Acute respiratory infection
- Acute sinusitis, otitis media or perforated eardrum
- Pneumothorax or pneumomediastinum
- Recent history of severe epistaxis requiring medical attention
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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