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

NCT00503802 | Completed Phase 2 DMC

• 3 other identifiers: 30678-D06-3050-D 02R01HL084139
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 3

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.

Conditions

Sleep Apnea Syndromes; Nasal Obstruction; Turbinate Hypertrophy

Keywords

Sleep Apnea; Sleep disordered breathing; Nasal Obstruction; Turbinate; Radiofrequency; Continuous positive airway pressure; CPAP; Sleep surgery

Outcome Measures

Primary Outcomes (3)

• Nasal minimum cross-sectional area (measured objectively with acoustic rhinometry)

  Primary outcome at 3 months, secondary outcomes at 6 and 12 months

• CPAP use (measured objectively as pressure-on use)

  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 Outcomes (5)

• 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

• 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

• 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

• Adverse events

  Any time research participant reports and scheduled evaluations at 3, 6, and 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Active RF treatment

Procedure: Radiofrequency Turbinate Reduction

2

SHAM COMPARATOR

Sham RF treatment

Procedure: Sham RF

Interventions

Radiofrequency Turbinate Reduction PROCEDURE

Radiofrequency Turbinate Reduction

1

Sham RF 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.

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator

Study Sites (3)

UW Sleep Disorders Center at Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98104, United States

Location

University of Washington General Clinical Research Center

Seattle, Washington, 98195, United States

Location

Related Publications (11)

• 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. doi: 10.1097/00005537-200110000-00023.

  PMID: 11801946 BACKGROUND

• 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.

  PMID: 16408415 BACKGROUND

• 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. doi: 10.1159/000089836. Epub 2005 Nov 18.

  PMID: 16299414 BACKGROUND

• 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. doi: 10.2500/ajr.2006.20.2940.

  PMID: 17063739 BACKGROUND

• 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. doi: 10.1016/j.otohns.2003.09.016.

  PMID: 14990910 BACKGROUND

• 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. doi: 10.1016/S0194-5998(00)70147-1.

  PMID: 10629486 BACKGROUND

• Hilberg O, Pedersen OF. Acoustic rhinometry: recommendations for technical specifications and standard operating procedures. Rhinol Suppl. 2000 Dec;16:3-17.

  PMID: 11225287 BACKGROUND

• 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. doi: 10.1164/ajrccm.158.2.9712036.

  PMID: 9700127 BACKGROUND

• 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. doi: 10.1164/ajrccm.165.2.2010008.

  PMID: 11790647 BACKGROUND

• 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.

  PMID: 12615790 BACKGROUND

• Jara SM, Hopp ML, Weaver EM. Association of Continuous Positive Airway Pressure Treatment With Sexual Quality of Life in Patients With Sleep Apnea: Follow-up Study of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jul 1;144(7):587-593. doi: 10.1001/jamaoto.2018.0485.

  PMID: 29800001 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Nasal Obstruction

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Otorhinolaryngologic Diseases

Study Officials

• Edward M. Weaver, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 19, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (3)