Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503802
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2007-07-17
Brief Title:
Randomized Clinical Trial of Nasal Turbinate Reduction to Improve Continuous Positive Airway Pressure CPAP Outcomes for Sleep Apnea
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Turbinate Reduction CPAP Use A Randomized Blinded OSA TURBO Trial
Status:
COMPLETED
Status Verified Date:
2013-06
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:
TURBO
Brief Summary:
Obstructive sleep apnea occurs in 2-4 of middle age adults and results in significant morbidity and mortality The first line therapy is provision of continuous positive airway pressure CPAP via a nasal mask chronically Nasal resistance related to nasal turbinate enlargement may compromise CPAP treatment This randomized double-blind sham-placebo-controlled trial tests the hypothesis that nasal turbinate reduction improves the nasal passage CPAP use and sleep apnea quality of life in newly diagnosed sleep apnea patients who are recommended CPAP therapy
Detailed Description:
Obstructive sleep apnea syndrome afflicts at least 2 - 4 of adults and is associated with significant morbidity and mortality Continuous positive airway pressure CPAP therapy is the primary treatment for sleep apnea in adults but non-adherence to CPAP limits its effectiveness Even with maximal medical therapy nasal obstruction is common in sleep apnea patients and may hamper both CPAP adherence and efficacy However the most common cause of nasal obstruction in sleep apnea patients turbinate hypertrophy is surgically correctable Treatment of nasal obstruction may lead to more successful use of CPAP The long-term goal of the proposed research is to develop a novel multi-disciplinary multi-modal approach to therapy in order to improve clinically important treatment outcomes for sleep apnea The short-term objectives of this proposal are to
1 Quantify the effect of nasal turbinate reduction on the nasal airway
2 Determine whether turbinate reduction increases CPAP use or efficacy and
3 Determine whether turbinate reduction positively influences CPAP treatment outcomes
We will employ a single-site randomized double-blind sham-placebo-controlled trial to test the hypotheses that turbinate reduction
1 increases nasal airway cross-sectional area
2 increases mean nightly objective CPAP use and
3 improves sleep apnea quality of life 3 months after CPAP titration
We will use the radiofrequency turbinate reduction surgical technique which allows ethical randomization and effective blinding Three six and 12 months after turbinate reduction and CPAP titration we will measure the change in the minimal nasal cross-sectional area level of CPAP use and improvement in sleep apnea quality of life Secondary outcomes will capture this treatments broader impact on the nose CPAP and sleep apnea If turbinate reduction can be shown to improve sleep apnea outcomes through increased use or efficacy of CPAP therapy this trial will demonstrate the value and effectiveness of a novel multidisciplinary combined medical-surgical approach to the management of obstructive sleep apnea syndrome
1 Quantify the effect of nasal turbinate reduction on the nasal airway
2 Determine whether turbinate reduction increases CPAP use or efficacy and
3 Determine whether turbinate reduction positively influences CPAP treatment outcomes
We will employ a single-site randomized double-blind sham-placebo-controlled trial to test the hypotheses that turbinate reduction
1 increases nasal airway cross-sectional area
2 increases mean nightly objective CPAP use and
3 improves sleep apnea quality of life 3 months after CPAP titration
We will use the radiofrequency turbinate reduction surgical technique which allows ethical randomization and effective blinding Three six and 12 months after turbinate reduction and CPAP titration we will measure the change in the minimal nasal cross-sectional area level of CPAP use and improvement in sleep apnea quality of life Secondary outcomes will capture this treatments broader impact on the nose CPAP and sleep apnea If turbinate reduction can be shown to improve sleep apnea outcomes through increased use or efficacy of CPAP therapy this trial will demonstrate the value and effectiveness of a novel multidisciplinary combined medical-surgical approach to the management of obstructive sleep apnea syndrome
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-3050-D 02 | OTHER | None | None |
| R01HL084139 | NIH | University of Washington Human Subjects Division | httpsreporternihgovquickSearchR01HL084139 |