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

NCT ID: NCT00503802

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-06-30

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.

Conditions

Sleep Apnea Syndromes; Nasal Obstruction; Turbinate Hypertrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Active RF treatment

Group Type: ACTIVE_COMPARATOR

Radiofrequency Turbinate Reduction

Intervention Type: PROCEDURE

Radiofrequency Turbinate Reduction

2

Sham RF treatment

Group Type: SHAM_COMPARATOR

Sham RF

Intervention Type: PROCEDURE

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.

Interventions

Radiofrequency Turbinate Reduction

Radiofrequency Turbinate Reduction

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Ed Weaver

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward M. Weaver, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

UW Sleep Disorders Center at Harborview Medical Center

Seattle, Washington, United States

Virginia Mason Medical Center

Seattle, Washington, United States

University of Washington General Clinical Research Center

Seattle, Washington, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 11801946 (View on PubMed)

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. doi: 10.1093/sleep/28.12.1554.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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. doi: 10.1161/01.cir.0000052627.99976.18.

Reference Type: BACKGROUND

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Reference Type: DERIVED

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Other Identifiers

06-3050-D 02

Identifier Type: OTHER

Identifier Source: secondary_id

R01HL084139

Identifier Type: NIH

Identifier Source: secondary_id

View Link

30678-D

Identifier Type: -

Identifier Source: org_study_id