Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea

The Chinese University of Hong Kong

Status: Completed

Conditions: Sleep Apnea

Treatments: Device: CPAP; Device: home sleep study; Device: home CPAP titration (Autoset)

Study type: Interventional

Funder types: Other

Identifiers

NCT00425659

CRE-2006.404-T

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

3

Active Comparator group

Treatment:

Device: home CPAP titration (Autoset)

1

Experimental group

Treatment:

Device: home sleep study

2

Other group

Description:

usual practice

Treatment:

Device: CPAP