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Ambulatory Versus Conventional Approach Diagnosing OSA

NCT01828216 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2016-03-29

Study results available
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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.

Conditions

  • OSA

Interventions

DEVICE

Home sleep study

The home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events

DEVICE

conventional polysomnography

conventional type I sleep study according to international guidelines

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • David Hui, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01828216 on ClinicalTrials.gov