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

PHASE2CompletedINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
Sleep Apnea SyndromesNasal ObstructionTurbinate Hypertrophy
Interventions
PROCEDURE

Radiofrequency Turbinate Reduction

Radiofrequency Turbinate Reduction

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.

Trial Locations (3)

98104

UW Sleep Disorders Center at Harborview Medical Center, Seattle

Virginia Mason Medical Center, Seattle

98195

University of Washington General Clinical Research Center, Seattle

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

lead

University of Washington

OTHER

NCT00503802 - Randomized Clinical Trial of Nasal Turbinate Reduction to Improve Continuous Positive Airway Pressure (CPAP) Outcomes for Sleep Apnea | Biotech Hunter | Biotech Hunter