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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00307424
First received: March 27, 2006
Last updated: NA
Last verified: August 2004
History: No changes posted
  Purpose

AutoCPAP would lead to better compliance than FixCPAP


Condition Intervention
Obstructive Sleep Apnea
 Device: AutoCPAP
Device: FixCPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:

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

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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.

Study Start Date: August 2004
Estimated Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307424

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

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00307424     History of Changes
Other Study ID Numbers: CRE-2004.258-T
Study First Received: March 27, 2006
Last Updated: March 27, 2006
Health Authority: Hong Kong: Hospital Authority
Hong Kong: The Chinese University of Hong Kong

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013