N/A
N=20
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT00906958 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Apnoea-Hypopnoea Index (AHI) — 1.69; 1.73 Events/Hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nexus Flow Generator (Device); VPAP Flow Generator 25 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnoea-Hypopnoea Index (AHI) |
1.69; 1.73 | — |
| PRIMARY Oxygen Desaturation Index |
1.95; 1.68 | — |
| SECONDARY Comfort of Breathing |
8.0; 7.0 | — |
| SECONDARY Satisfaction of Treatment |
9.5; 8.0 | — |
| SECONDARY Refreshed Feel |
9.0; 8.0 | — |
Summary
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.
Eligibility Criteria
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
- Patients who are unable to provide written informed consent
- Patients who are unable to comprehend written and spoken English
- Patients who are using Bilevel PAP
- Patients who are pregnant
- 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
Data sourced from ClinicalTrials.gov (NCT00906958). 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.