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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ed Weaver, University of Washington
ClinicalTrials.gov Identifier:
NCT00503802
First received: July 17, 2007
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Sleep Apnea Syndromes
Nasal Obstruction
Turbinate Hypertrophy
Procedure: Radiofrequency Turbinate Reduction
Procedure: Sham RF
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Turbinate Reduction & CPAP Use: A Randomized Blinded OSA (TURBO) Trial

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Nasal minimum cross-sectional area (measured objectively with acoustic rhinometry) [ Time Frame: Primary outcome at 3 months, secondary outcomes at 6 and 12 months ] [ Designated as safety issue: No ]
  • CPAP use (measured objectively as pressure-on use) [ Time Frame: Primary outcome at 3 months, secondary outcomes at 6 and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Secondary CPAP Outcome Measures: acceptance, subjective tolerance, pressure, leak, residual breathing events (measured by CPAP device) [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Any time research participant reports and scheduled evaluations at 3, 6, and 12 months ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: July 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503802

Locations
United States, Washington
UW Sleep Disorders Center at Harborview Medical Center
Seattle, Washington, United States, 98104
University of Washington General Clinical Research Center
Seattle, Washington, United States, 98195
Virginia Mason Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Edward M. Weaver, MD, MPH University of Washington
  More Information

Additional Information:
Publications:

Responsible Party: Ed Weaver, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00503802     History of Changes
Other Study ID Numbers: 30678-D, 06-3050-D 02, R01HL084139
Study First Received: July 17, 2007
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Sleep Apnea
Sleep disordered breathing
Nasal Obstruction
Turbinate
Radiofrequency
Continuous positive airway pressure
CPAP
Sleep surgery

Additional relevant MeSH terms:
Apnea
Hypertrophy
Nasal Obstruction
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathological Conditions, Anatomical
Nose Diseases
Airway Obstruction
Respiratory Insufficiency
Otorhinolaryngologic Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014