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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307424
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : March 28, 2006
Information provided by:
Chinese University of Hong Kong

Brief Summary:
AutoCPAP would lead to better compliance than FixCPAP

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: AutoCPAP Device: FixCPAP Not Applicable

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.


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 Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Comparison of Auto-Continuous Positive Airway Pressure Device(Auto-CPAP) With Conventional Fixed CPAP in Chinese Patients With Obstructive Sleep Apnea (OSA)
Study Start Date : August 2004
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Primary Outcome Measures :
  1. To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.
  2. 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.
  3. To compare patient acceptance of the different type of treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00307424

North District Hospital
Hong Kong, China
Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: To K Wang, FHKCP Prince of Wales Hosptial

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00307424     History of Changes
Other Study ID Numbers: CRE-2004.258-T
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: March 28, 2006
Last Verified: August 2004

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases