Comparison Between Auto CPAP and Fixed CPAP in Chinese Patients With OSA

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT00307424
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

AutoCPAP would lead to better compliance than FixCPAP

Detailed Description

A prospective, randomized crossover cohort. Study subjects consisted of patients newly diagnosed with obstructive sleep apnea (OSA) confirmed with sleep study. All are CPAP naïve.

Randomization:

Arm 1: auto CPAP sleep study then auto CPAP for 2 months Arm 2: fixed CPAP titration then fixed CPAP for 2 months

Then switch over to the other arm

Trial end after 4 months, compliance and other parameters would be compared between two arms as described in the endpoint session.

Study Timeline

• Status Verified: 2004-08
• Study Start: 2004-08
• Study Completion: 2005-06
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Last Update Submitted: 2006-03-27
• Study First Posted: 2006-03-28
• Last Update Posted: 2006-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All subjects should be CPAP naïve.
• OSA confirmed with sleep study
• Presence of daytime symptoms with excessive daytime sleepiness
• Age between 18 to 65
• RDI greater than 30
• Agreed to participate in trial with informed consent signed

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Exclusion Criteria

• Patients not suitable to nasal CPAP because of facial abnormality leading to poor mask fitting.
• Patients with known COPD with type II failure
• Patients with known heart failure.
• Patients with predominant central sleep apnea.
• Patients need bilevel positive airway pressure ventilation.
• Patients refusing to participate the trial.
• Patients have difficulty to follow up regularly.
• patients with untreated or under treatment of hypothyroidism

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.
To compare the clinical efficacy of auto-CPAP and fixed CPAP in terms of pressure level to abolish OSA, Epworth sleepiness scale and quality of life questionnaire.
To compare patient acceptance of the different type of treatment.

Trial Locations

Locations (2)

Prince of Wales Hospital; 🇨🇳 Hong Kong, China

North District Hospital; 🇨🇳 Hong Kong, China