Randomized Clinical Trial of Nasal Turbinate Reduction to Improve Continuous Positive Airway Pressure (CPAP) Outcomes for Sleep Apnea
Condition: Sleep Apnea Syndromes; Nasal Obstruction; Turbinate Hypertrophy
MeSH terms: Apnea; Sleep Apnea Syndromes; Nasal Obstruction; Hypertrophy
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Radiofrequency Turbinate Reduction; Sham RF
Intervention type(s): Procedure; Procedure
Intervention description(s): Radiofrequency Turbinate Reduction; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sleep Apnea; Sleep disordered breathing; Nasal Obstruction; Turbinate; Radiofrequency; Continuous positive airway pressure; CPAP; Sleep surgery