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

June 17, 2013 updated by: Ed Weaver, University of Washington

Turbinate Reduction & CPAP Use: A Randomized Blinded OSA (TURBO) Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

242

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98195
        • University of Washington General Clinical Research Center
      • Seattle, Washington, United States, 98104
        • UW Sleep Disorders Center at Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Active RF treatment
Procedure: Radiofrequency Turbinate Reduction
Radiofrequency Turbinate Reduction
Sham Comparator: 2
Sham RF treatment
Procedure: Sham RF
The steps of the procedure are as follows: 1) application of topical anesthetic to the turbinate mucosa bilaterally; 2) injection of 1.0 ml of lidocaine 1% with epinephrine 1:100,000 with a 30-gauge needle into each inferior turbinate anteriorly; 3) delay five minutes for local anesthetic to take full effect; 4) re-insertion of the anesthetic needle to check for complete anesthesia on one side, and injection of another 1.0 ml of lidocaine 1% with epinephrine 1:100,000 5) placement of the radiofrequency electrode (23-gauge, 1 cm long) into the inferior turbinate; 6) delivery of 300 Joules of radiofrequency energy to the turbinate over 29 seconds (no energy will be delivered in sham procedure)7) placement of a cotton pledget (soaked in oxymetazoline solution 0.05%) against the treatment site 8) repeat steps 3 - 8 for the contra-lateral inferior turbinate; 9) removal of the cotton pledgets after several minutes; and 11) observation of hemostasis.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary Nasal Outcome Measures: peak inspiratory flow, resistance (rhinomanometry), endoscopy, smell identification test, nasal obstruction symptom evaluation (NOSE) scale, and other nasal treatment history
Time Frame: 3, 6, and 12 months
3, 6, and 12 months
Secondary CPAP Outcome Measures: acceptance, subjective tolerance, pressure, leak, residual breathing events (measured by CPAP device)
Time Frame: 3, 6, and 12 months
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)
Time Frame: 3, 6, and 12 months
3, 6, and 12 months
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
Time Frame: 3, 6, and 12 months
3, 6, and 12 months
Adverse events
Time Frame: Any time research participant reports and scheduled evaluations at 3, 6, and 12 months
Any time research participant reports and scheduled evaluations at 3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Edward M. Weaver, MD, MPH, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30678-D
  • 06-3050-D 02 (Other Identifier: University of Washington Human Subjects Division)
  • R01HL084139 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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