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

Obstructive Sleep Apnea Clinical Trial

Official title:

Comparison of Auto-Continuous Positive Airway Pressure Device(Auto-CPAP) With Conventional Fixed CPAP in Chinese Patients With Obstructive Sleep Apnea (OSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307424
• Other study ID #: CRE-2004.258-T
• Status: Completed
• Phase: N/A
• First received: March 27, 2006
• Last updated: March 27, 2006
• Start date: August 2004
• Est. completion date: June 2005

Study information

• Verified date: August 2004
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Hospital AuthorityHong Kong: The Chinese University of Hong Kong
• Study type: Interventional

Clinical Trial Summary

AutoCPAP would lead to better compliance than FixCPAP

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Device:
• AutoCPAP

• FixCPAP

Locations

Country	Name	City	State
China	North District Hospital	Hong Kong
China	Prince of Wales Hospital	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	To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.
Primary	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.
Primary	To compare patient acceptance of the different type of treatment.