Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425659
• Other study ID #: CRE-2006.404-T
• Status: Completed
• Phase: N/A
• First received: January 22, 2007
• Last updated: July 9, 2009
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• home sleep study
different in algorithm arrangement for diagnosing sleep apnea
• home CPAP titration (Autoset)
continuous positive airway pressure device for treatment of sleep apnea
• CPAP
usual practice

Locations

Country	Name	City	State
China	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of the new home sleep study device compare with conventional inpatient sleep study		1 year	No
Secondary	The relative efficacy between different algorithm		1 year	No
Secondary	Failure rates in different algorithms which need to switch to the conventional algorithm		1 year	No