44
Participants
Start Date
September 30, 2007
Primary Completion Date
July 31, 2010
Study Completion Date
July 31, 2010
Thermosmart & placebo
a Fisher \& Paykel 604 CPAP machine with Thermosmart™ heated humidity set at their prescribed pressure. Subjects will also be given nasal steroid placebo (purified water) and instructed to deliver two sprays in each nostril daily
Placebo Device & Nasacort
Visit 3 will be identical to visit 2, with the exception being the crossover of double-blind treatment. Subjects will now receive the Fisher \& Paykel 604 CPAP machine with traditional heated humidity and a deactivated Thermosmart™ tube set to their prescribed pressure. Subjects will also be given the nasal steroid Nasacort AQ (triamcinolone acetonide) at a dosage of 220 mcg. They will be instructed to deliver two sprays in each nostril daily. Once again, phone follow-up will be made 7-10 days after the visit to assess compliance with study procedures and adverse events.
Placebo Arm
"To enter into the single-blind placebo phase, subjects will be setup with a Fisher \& Paykel 604 CPAP unit with a heated humidifier and deactivated Thermosmart™ tube, thus, only traditional heated humidity will be available. The deactivated unit will still appear to function with intact heated humidity settings. The CPAP machine will be set to the patient's prescribed pressure. Subjects will also be given a nasal steroid spray placebo and instructed to deliver one spray in each nostril daily."
Clayton Sleep Institute, St Louis
Clayton Sleep Insititute
INDUSTRY