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

Sleep Apnea Syndromes Clinical Trial

— TURBO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503802
• Other study ID #: 30678-D
• Secondary ID: 06-3050-D 02R01H
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2007
• Last updated: June 17, 2013
• Start date: July 2007
• Est. completion date: June 2011

Study information

• Verified date: June 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrophy
• Nasal Obstruction
• Sleep Apnea Syndromes
• Turbinate Hypertrophy

Intervention

Procedure:
• Radiofrequency Turbinate Reduction
Radiofrequency Turbinate Reduction
• 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.

Locations

Country	Name	City	State
United States	University of Washington General Clinical Research Center	Seattle	Washington
United States	UW Sleep Disorders Center at Harborview Medical Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (10)

Flemons WW, Reimer MA. Development of a disease-specific health-related quality of life questionnaire for sleep apnea. Am J Respir Crit Care Med. 1998 Aug;158(2):494-503. — View Citation

Flemons WW, Reimer MA. Measurement properties of the calgary sleep apnea quality of life index. Am J Respir Crit Care Med. 2002 Jan 15;165(2):159-64. — View Citation

Friedman M, Tanyeri H, Lim JW, Landsberg R, Vaidyanathan K, Caldarelli D. Effect of improved nasal breathing on obstructive sleep apnea. Otolaryngol Head Neck Surg. 2000 Jan;122(1):71-4. — View Citation

Hilberg O, Pedersen OF. Acoustic rhinometry: recommendations for technical specifications and standard operating procedures. Rhinol Suppl. 2000 Dec;16:3-17. Erratum in: Rhinol 2001 Jun;39(2):119. — View Citation

Lam DJ, James KT, Weaver EM. Comparison of anatomic, physiological, and subjective measures of the nasal airway. Am J Rhinol. 2006 Sep-Oct;20(5):463-70. — View Citation

Li HY, Engleman H, Hsu CY, Izci B, Vennelle M, Cross M, Douglas NJ. Acoustic reflection for nasal airway measurement in patients with obstructive sleep apnea-hypopnea syndrome. Sleep. 2005 Dec;28(12):1554-9. — View Citation

Powell NB, Zonato AI, Weaver EM, Li K, Troell R, Riley RW, Guilleminault C. Radiofrequency treatment of turbinate hypertrophy in subjects using continuous positive airway pressure: a randomized, double-blind, placebo-controlled clinical pilot trial. Laryngoscope. 2001 Oct;111(10):1783-90. — View Citation

Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. — View Citation

Sugiura T, Noda A, Nakata S, Yasuda Y, Soga T, Miyata S, Nakai S, Koike Y. Influence of nasal resistance on initial acceptance of continuous positive airway pressure in treatment for obstructive sleep apnea syndrome. Respiration. 2007;74(1):56-60. Epub 2005 Nov 18. — View Citation

Yokoe T, Minoguchi K, Matsuo H, Oda N, Minoguchi H, Yoshino G, Hirano T, Adachi M. Elevated levels of C-reactive protein and interleukin-6 in patients with obstructive sleep apnea syndrome are decreased by nasal continuous positive airway pressure. Circulation. 2003 Mar 4;107(8):1129-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal minimum cross-sectional area (measured objectively with acoustic rhinometry)		Primary outcome at 3 months, secondary outcomes at 6 and 12 months	No
Primary	CPAP use (measured objectively as pressure-on use)		Primary outcome at 3 months, secondary outcomes at 6 and 12 months	No
Primary	Sleep Apnea Quality of Life Index (change measured with Then Test technique)		Primary outcome at 3 months, secondary outcomes at 6 and 12 months	No
Secondary	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	No
Secondary	Secondary CPAP Outcome Measures: acceptance, subjective tolerance, pressure, leak, residual breathing events (measured by CPAP device)		3, 6, and 12 months	No
Secondary	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	No
Secondary	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	No
Secondary	Adverse events		Any time research participant reports and scheduled evaluations at 3, 6, and 12 months	No

External Links

•   Sleep Apnea Research Group