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Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea

Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea in High Risk Population in Hong Kong

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00425659
Enrollment
150
Registered
2007-01-23
Start date
2007-01-31
Completion date
2009-06-30
Last updated
2009-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

Health utility, Home sleep study

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.

Interventions

different in algorithm arrangement for diagnosing sleep apnea

DEVICEhome CPAP titration (Autoset)

continuous positive airway pressure device for treatment of sleep apnea

DEVICECPAP

usual practice

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Validity of the new home sleep study device compare with conventional inpatient sleep study1 year

Secondary

MeasureTime frame
The relative efficacy between different algorithm1 year
Failure rates in different algorithms which need to switch to the conventional algorithm1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026