Randomized Clinical Trial of Nasal Turbinate Reduction to Improve Continuous Positive Airway Pressure (CPAP) Outcomes for Sleep Apnea

Phase 2

Completed

• Conditions: Turbinate Hypertrophy; Sleep Apnea Syndromes; Nasal Obstruction
• Interventions: Procedure: Radiofrequency Turbinate Reduction; Procedure: Sham RF

• Registration Number: NCT00503802
• Lead Sponsor: University of Washington

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 treatment's 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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-19
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• Age 18-80 years
• Newly diagnosed obstructive sleep apnea (apnea-hypopnea index >= 5 events/hour)
• CPAP therapy recommended
• Persistent bilateral inferior turbinate hypertrophy
• American Society of Anesthesiologists Class I-III
• Ability to give informed consent
• Ability and willingness to complete the study protocol
• Fluency in verbal and written English

Read More

Exclusion Criteria

• Previous surgical turbinate treatment
• Other nasal disorders (i.e. recurrent epistaxis, desiccated or crusted mucosa, severe bilateral obstructing septal deformity, or obstructing polyposis)
• Active respiratory tract infections
• Coagulopathy
• Severe psychiatric comorbidity (taking anti-psychotic medication)
• American Society of Anesthesiologists Class IV or V
• Pregnancy
• No telephone
• Plans of moving during the study period
• Known contraindication to lidocaine with epinephrine, oxymetazoline, or acetaminophen

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Radiofrequency Turbinate Reduction	Active RF treatment
2	Sham RF	Sham RF treatment

Primary Outcome Measures

Name	Time	Method
CPAP use (measured objectively as pressure-on use)	Primary outcome at 3 months, secondary outcomes at 6 and 12 months
Nasal minimum cross-sectional area (measured objectively with acoustic rhinometry)	Primary outcome at 3 months, secondary outcomes at 6 and 12 months
Sleep Apnea Quality of Life Index (change measured with Then Test technique)	Primary outcome at 3 months, secondary outcomes at 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary Clinical Outcome Subjective Measures: Quality of Life Change, Symptoms of Nocturnal Obstruction & Related Events (SNORE-25) Scale, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and Short Form-36 version 2	3, 6, and 12 months
Secondary Clinical Outcome Objective Measures: vigilance (psychomotor vigilance task monitor), blood pressure, and plasma C-reactive protein (cardiovascular risk biomarker)	3, 6, and 12 months
Adverse events	Any time research participant reports and scheduled evaluations at 3, 6, and 12 months
Secondary Nasal Outcome Measures: peak inspiratory flow, resistance (rhinomanometry), endoscopy, smell identification test, nasal obstruction symptom evaluation (NOSE) scale, and other nasal treatment history	3, 6, and 12 months
Secondary CPAP Outcome Measures: acceptance, subjective tolerance, pressure, leak, residual breathing events (measured by CPAP device)	3, 6, and 12 months

Trial Locations

Locations (3)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

UW Sleep Disorders Center at Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

University of Washington General Clinical Research Center; 🇺🇸 Seattle, Washington, United States