Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00491088
Status:
COMPLETED
Last Update Posted:
2010-03-01
First Post:
2007-06-21
Brief Title:
The CPAP Effect in Severe Obstructive- Sleep- Apnea Patients Without Daytime Sleepiness A Control Randomized Trial
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The CPAP Effect in Severe Obstructive- Sleep- Apnea Patients Without Daytime Sleepiness A Control Randomized Trial
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 didnt 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 couldnt 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 doesnt 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
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 didnt 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 couldnt 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 doesnt 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None