Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea

Study Overview
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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.

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

Conditions
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Sleep Apnea

Intervention / Treatment
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* Device: home sleep study
* Device: home CPAP titration (Autoset)
* Device: CPAP


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3<br> | Device: home CPAP titration (Autoset)<br>* continuous positive airway pressure device for treatment of sleep apnea<br>* Other names: Autoset;|
| Experimental: 1<br> | Device: home sleep study<br>* different in algorithm arrangement for diagnosing sleep apnea<br>* Other names: different algorithm arrangement;|
| Other: 2<br>usual practice | Device: CPAP<br>* usual practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of the new home sleep study device compare with conventional inpatient sleep study |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relative efficacy between different algorithm |  | 1 year | 
| Failure rates in different algorithms which need to switch to the conventional algorithm |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health utility, Home sleep study