Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518128
Status:
COMPLETED
Last Update Posted:
2012-05-22
First Post:
2007-08-16
Brief Title:
Measuring Effectiveness in Sleep Apnea Surgery
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Measuring Effectiveness in Sleep Apnea Surgery
Status:
COMPLETED
Status Verified Date:
2012-05
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:
The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery To achieve this goal we will examine key health-related C-reactive protein homocysteine leptin the homeostasis model of insulin resistance and heart rate variability and functional sleep-related quality of life and vigilance measures among a surgical group of OSA patients who do not tolerate non-surgical treatment positive airway pressure PAP and a comparison group of matched OSA patients who tolerate PAP
Detailed Description:
The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery To achieve this goal we will examine key health-related C-reactive protein homocysteine leptin the homeostasis model of insulin resistance and heart rate variability and functional sleep-related quality of life and vigilance measures among a surgical group of OSA patients who do not tolerate non-surgical treatment positive airway pressure PAP and a comparison group of matched OSA patients who tolerate PAP We propose to measure the impact of surgical OSA treatment on these health-related and functional outcomes measures with the following three analyses 1 to assess the changes seen with surgical treatment 2 to compare changes seen with surgical and PAP treatment and 3 to evaluate the association between changes in respiratory patterns during sleep and changes in health-related and functional outcomes measures for both surgical and PAP treatment
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