Ambulatory Versus Conventional Approach Diagnosing OSA

OSA Clinical Trial

Official title:

A Randomized Controlled Study Assessing the Role of an Ambulatory Approach Versus the Conventional Approach in Managing Suspected Obstructive Sleep Apnoea Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01828216
• Other study ID #: amb_hosp_OSA
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2013
• Last updated: April 8, 2013
• Start date: January 2013

Study information

• Verified date: April 2013
• Source: Chinese University of Hong Kong
• Contact: Karen Yiu
• Phone: 852 26323532
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Very few studies have examined different models of care involving initial ambulatory home-based diagnosis in diagnosing OSA, identifying patients who benefit from CPAP, and reducing the need for 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• symptoms of OSA with home embletta AHI >= 15/hr.

Exclusion Criteria:

• unstable cardiovascular diseases (e.g. recent unstable angina, myocardial infarction, stroke or TIA 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 SaO2 <92%

• psychiatric disease that limits the ability to give informed consent or complete the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• OSA
• Sleep Apnea, Obstructive

Intervention

Device:
• Embletta
The EmblettaTM PDS 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 anpea-hyponea 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
• conventional PSG
conventional type I sleep study according to ASSM

Locations

Country	Name	City	State
China	The Chinese University of Hong Kong	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in ESS before and after 3 months of CPAP treatment		3 months	No
Secondary	difference in healthcare costs between ambulatory and hospital approach		within 24 months	No