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OpenTrials
Completed

NCT Number: NCT00307424

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

AutoCPAP would lead to better compliance than FixCPAP

Completed

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North District Hospital, Hong Kong, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AutoCPAP

Device

FixCPAP

Device

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Mar 28, 2006
Registry last updated
Mar 28, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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