Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea
• Interventions: Device: home CPAP titration (Autoset); Device: home sleep study; Device: CPAP

• Registration Number: NCT00425659
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Newer home sleep study device and algorithm provides an alternative for inpatient sleep study and improve the service provides to patients

Detailed Description

Purpose: Assess different potential algorithms to improve the service and cost utility for diagnosis and treatment of obstructive sleep apnea syndrome (OSAS) in patients with high pretest probability in Hong Kong.

Hypothesis: Newer home sleep study device and algorithm provides an alternative for inpatient sleep study Design: Prospective randomized study Subject: High pretest probability of OSAS patients referred to a tertiary centre.

Study instruments: a portable sleep study device, AutoCPAP and inpatient sleep monitoring system.

Interventions: comparison between 3 different algorithms of health service for OSA patients would be made: conventional in-patient sleep study, empirical treatment and home sleep study.

Main outcome measures: The primary outcome is the validity of the home sleep study device compare to inpatient sleep study. The secondary outcomes are the relative efficacy of different algorithms and the numbers of failed procedures in each algorithm.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-22
• Study First Submitted QC: 2007-01-22
• Study First Posted: 2007-01-23
• Primary Completion: 2009-03
• Study Completion: 2009-06
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-09
• Last Update Posted: 2009-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adult patients with high pretest probability of OSAS, i.e. ESS > 10 or symptomatic patients, with BMI > 23 and/or cranial facial features associated with OSA, as assessed by the attending respiratory physician in the respiratory clinic.
• Patients aged between 18-65 years who agree to participate in the study.

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Exclusion Criteria

• Pregnant women
• Patients who refuse signing consent of the study
• Do not have high pretest probability of OSAS
• Refuse to have home sleep study
• Refuse any treatment offered; or
• Could not comply with the set up of home study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	home CPAP titration (Autoset)	-
1	home sleep study	-
2	CPAP	usual practice

Primary Outcome Measures

Name	Time	Method
Validity of the new home sleep study device compare with conventional inpatient sleep study	1 year

Secondary Outcome Measures

Name	Time	Method
The relative efficacy between different algorithm	1 year
Failure rates in different algorithms which need to switch to the conventional algorithm	1 year

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇨🇳 Hong Kong, China