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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clayton Sleep Insititute
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Between the ages of 18-65

• Diagnosis of obstructive sleep apnea (OSA) with apnea/hypopnea index (AHI) > 15/hr

• Currently using CPAP therapy and within 3 weeks to 12 months of initial CPAP titration

• Based on the CPAP nasal symptom questionnaire, a score of at least 3 (sometimes) for at least one of the following nasal symptoms related to their sleep apnea and CPAP usage: nasal congestion, runny nose, sneezing, or nasal irritation

• Willingness to tolerate and continue therapy with nCPAP

• Successfully titrated on nCPAP in a sleep center to a pressure between 6-16 cmH2O

• Willingness to comply and complete study related procedures

• Fluent in the English language

Exclusion Criteria:

• Co-morbid medical condition that is either medically significant and unstable, would interfere with the patient's ability to routinely use CPAP, or is a contraindication for use of a nasal steroid

• Women who are pregnant or who may potentially become pregnant during the course of the research trial.

• CPAP compliance over the past three weeks at screening > 5 hours/night, suggesting no compromised CPAP usage due to adverse nasal symptoms

• Wake resting SaO2 < 90%

• Currently using Bi-Level therapy, supplemental oxygen with CPAP therapy, or using a pressure outside inclusion criteria

• Currently using a Full-Face mask for CPAP therapy

• Current or prior use of the Fisher Paykel 604 CPAP machine with Thermosmart™ heated humidity.

• Patients who were never prescribed a heated humidifier with their CPAP machine (i.e. no humidifier or passover humidifier).

• Intranasal steroid treatment within the previous six months. Patient's currently taking intranasal steroid treatment cannot wash-out of steroid treatment to be included nor if patients have used nasal steroid treatment while on CPAP therapy

• Current upper airway tract infection, influenza, respiratory infection at time of screening or nasal surgery within 90 days of screening

• Prior surgical intervention for obstructive sleep apnea

• Currently taking medications that would be contraindicated to using a nasal steroid. Patients taking hypnotic or wake promoting therapy can participate if they have been on a stable dose prior to CPAP therapy and willing to maintain current dose as prescribed.

• Shift or rotating shift workers or individuals who routinely cannot contribute at least 6 hours/night to sleep/attempting therapy

• Additional sleep disorder that would interfere with routine use of CPAP