N/A
N=316
Ambulatory Versus Conventional Approach Diagnosing OSA
OSA
Bottom Line
View on ClinicalTrials.gov: NCT01828216 ↗Enrolled (actual)
316
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment — -2.2; -3.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home sleep study (Device); conventional polysomnography (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chinese University of Hong Kong
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment |
-2.2; -3.5 | — |
| SECONDARY Difference in Healthcare Costs Between Ambulatory and Hospital Approach |
16178; 2332 | — |
Summary
Very few studies have examined different models of care involving initial ambulatory home-based diagnosis in diagnosing obstructive sleep apnea (OSA), identifying patients who benefit from continuous positive airway pressure (CPAP), and reducing the need for polysomnography (PSG). This study aims to assess the role of an ambulatory approach with home diagnostic sleep study. We hypothesize that the ambulatory approach is as good as the conventional approach in managing OSA in terms of improvement of clinical outcome but the former approach will lead to substantial cost savings.
Eligibility Criteria
Inclusion Criteria
- symptoms of OSA with home sleep study AHI >= 15/hr.
Exclusion Criteria
- unstable cardiovascular diseases (e.g. recent unstable angina, myocardial infarction, stroke or transient ischemic attack within the previous 6 months or severe left ventricular failure)
- neuromuscular disease affecting or potentially affecting respiratory muscles
- moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake oxygen saturation of <92%
- psychiatric disease that limits the ability to give informed consent or complete the study
Data sourced from ClinicalTrials.gov (NCT01828216). 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.