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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00491088
First received: June 21, 2007
Last updated: February 25, 2010
Last verified: February 2010
  Purpose

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.

Condition Intervention
Sleep Apnea, Obstructive
Device: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The CPAP Effect in Severe Obstructive- Sleep- Apnea Patients Without Daytime Sleepiness: A Control Randomized Trial

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • improvement of sleepiness [ Time Frame: after 4-week and 12-week CPAP treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement of fatigue and QOL, sympathetic activity, inflammatory mediators and metabolism [ Time Frame: after 4-week and 12-week CPAP treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CPAP
    CPAP for 12 weeks
Detailed Description:

Obstructive sleep apnea (OSA) is a common disease, which affects 4% middle-aged men and 2% women. Daytime sleepiness is one of the symptoms of OSA which drive patients to seek medical help. Sleepiness in OSA has been reported to be raised by microarousal, altered sleep structure and somnogenic cytokine and modifications in body metabolism. The assessments of daytime sleepiness included objective measures, like multiple sleep latency test and subjective measures, like Epworth sleepiness scale (ESS).

So far, continuous positive airway pressure (CPAP) is the standard treatment for patients with severe OSA. CPAP could improve daytime wakefulness, blood pressure and quality of life (QOL). Several studies tried to identify factors predicting the CPAP effect and most concluded CPAP was not effective for patients with high apnea-hypopnea index but not sleepy. All of them determine the CPAP effect in terms of daytime function, lowering of blood pressure and QOL. None of these studies evaluate the CPAP effects in terms of improvement of sympathetic hyperactivity, inflammatory mediators and metabolic abnormalities. Therefore, we assumed patients whose daytime functions didn't improve after CPAP treatment still possibly got benefit from altering factors contributing to cardiovascular consequences.

Our previous study showed that CPAP effect in OSA patients without sleepiness was as well as in patients with sleepiness, except that plasma level of norepinephrine and 24hr mean arterial blood pressure could be lowered more in patients with sleepiness. However, without optimal placebo and randomization, the actual role of CPAP in treating non-sleepy OSA patients still couldn't be determined.

Recently sham CPAP was developed, which mimicked all the characteristics of a true CPAP except for the null pressure applied to the upper airway of the patient. Moreover, sham CPAP doesn't influence sleep efficiency, arousals, or apnea-hypopnea index. Therefore, in this project, using sham CPAP as a placebo, we propose a randomized double-blind placebo controlled trial to assess the effectiveness of CPAP in severe OSA patients without daytime sleepiness. We also establish a model to predict the CPAP effect. The results would change the current practice of managing severe OSA patients without daytime sleepiness.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe obstructive sleep apnea (AHI>=30/hr) age, sex, BMI match control subject

Exclusion Criteria:

Patients were excluded when they:

  • Refused to participate in this study
  • Had severe obstructive pulmonary disease or active neurological events
  • Enrolled in other studies at the same time
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491088

Locations
Taiwan
Naitonal Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Whey Dong Wu, M.D. National Taiwan University Hospital
Principal Investigator: Peilin Lee, M.D. National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Peilin Lee/attending physician, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00491088     History of Changes
Other Study ID Numbers: 200701063R
Study First Received: June 21, 2007
Last Updated: February 25, 2010
Health Authority: Taiwan: Department of Health

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 April 21, 2014