Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea

NCT ID: NCT00425659

Last Updated: 2009-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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3

Group Type ACTIVE_COMPARATOR

home CPAP titration (Autoset)

Intervention Type DEVICE

continuous positive airway pressure device for treatment of sleep apnea

1

Group Type EXPERIMENTAL

home sleep study

Intervention Type DEVICE

different in algorithm arrangement for diagnosing sleep apnea

2

usual practice

Group Type OTHER

CPAP

Intervention Type DEVICE

usual practice

Interventions

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home sleep study

different in algorithm arrangement for diagnosing sleep apnea

Intervention Type DEVICE

home CPAP titration (Autoset)

continuous positive airway pressure device for treatment of sleep apnea

Intervention Type DEVICE

CPAP

usual practice

Intervention Type DEVICE

Other Intervention Names

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different algorithm arrangement Autoset

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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CUHK

Principal Investigators

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Kin W To, MBChB

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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CRE-2006.404-T

Identifier Type: -

Identifier Source: org_study_id

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