Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea

Chinese University of Hong Kong150 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

150

Conditions

Sleep Apnea

Interventions

home sleep studyDEVICE

different in algorithm arrangement for diagnosing sleep apnea

home CPAP titration (Autoset)DEVICE

continuous positive airway pressure device for treatment of sleep apnea

CPAPDEVICE

usual practice

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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. 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.

Locations (1)

The Chinese University of Hong Kong

Hong Kong, China

Outcomes

Primary Outcomes

Validity of the new home sleep study device compare with conventional inpatient sleep study

Time frame: 1 year

Secondary Outcomes

The relative efficacy between different algorithm

Time frame: 1 year

Failure rates in different algorithms which need to switch to the conventional algorithm

Time frame: 1 year

Data from ClinicalTrials.gov

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