Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure

PHASE3CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Obstructive Sleep ApneaNasal CongestionSinus Congestion
Interventions
DRUG

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

DRUG

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.

DEVICE

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."

Trial Locations (1)

63143

Clayton Sleep Institute, St Louis

All Listed Sponsors
lead

Clayton Sleep Insititute

INDUSTRY

NCT00665977 - Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure | Biotech Hunter | Biotech Hunter