Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure
Condition: Obstructive Sleep Apnea; Nasal Congestion; Sinus Congestion
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      1. CPAP compliance will be significantly higher in both the heated humidity with
           Thermosmart™ and the nasal steroid phases compared to the double placebo phase.

        2. CPAP compliance will be comparably improved in the heated humidity with Thermosmart™
           phase versus the nasal steroid phase.

        3. Improvement in nasal symptoms in using CPAP will be significantly improved in both the
           heated humidity with Thermosmart™ and the nasal steroid phases compared to the double
           placebo phase, and comparable between the heated humidity with Thermosmart™ phase versus
           the nasal steroid phase.

        4. Secondary to improvements in CPAP compliance, measures of daytime functioning and
           quality of life will improve in the heated humidity with Thermosmart™ versus double
           placebo.
    

Detailed description: 
      Eligible participants will undergo this double-blind, placebo controlled, single-blind double
      placebo run-in, crossover trial to determine the efficacy of heated humidity with
      Thermosmart™ in improving compliance and nasal symptoms in patients using CPAP versus a nasal
      steroid and placebo (heated humidity, nasal steroid placebo) phases. After successful
      screening, participants will undergo a two week single-blind double placebo run-in phase
      using heated humidity and a nasal steroid placebo. The double-blind treatment phase will last
      a total of six weeks. Participants will undergo both phases: three weeks using heated
      humidity with Thermosmart™ and nasal steroid placebo and three weeks using a nasal steroid
      with a heated humidifier. Treatment phases will be counterbalanced. Study participation will
      last a total of 8 weeks from screening to completion of double-blind treatment.
    

Intervention name(s): Thermosmart & placebo; Placebo Device & Nasacort; Placebo Arm
Intervention type(s): Drug; Drug; Device
Intervention description(s): 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; 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.; 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.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; Nasal Congestion; Sinus congestion