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Completed

NCT Number: NCT00425659

Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home sleep study

Device

different in algorithm arrangement for diagnosing sleep apnea

Other names: different algorithm arrangement

home CPAP titration (Autoset)

Device

continuous positive airway pressure device for treatment of sleep apnea

Other names: Autoset

CPAP

Device

usual practice

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. The relative efficacy between different algorithm

    Time frame: 1 year

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 23, 2007
Registry last updated
Jul 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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