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The CPAP Effect in Severe Obstructive- Sleep- Apnea Patients Without Daytime Sleepiness: A Control Randomized Trial

NCT00491088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2010-03-01

No results posted yet for this study

Summary

Specific Aim:

1. To prove our hypothesis that in severe OSA patients without daytime sleepiness, CPAP worked as effectively as in severe OSA patients with daytime sleepiness.

Using sham CPAP as the optimal placebo, we conduct a randomized double-blind placebo controlled trial to assess the CPAP effect in severe OSA patients without daytime sleepiness.
2. To establish a model to predict the CPAP effect We use the parameters of five aspects, including changes of polysomnographic parameters, improvement of sleepiness, fatigue and QOL, sympathetic activity, inflammatory mediators and metabolism, to establish a model to predict CPAP effect.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DEVICE

CPAP

CPAP for 12 weeks

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Whey Dong Wu, M.D. · National Taiwan University Hospital

  • Peilin Lee, M.D. · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-08-31
Completion
2009-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00491088 on ClinicalTrials.gov