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

Completed · Phase 3 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea, Nasal Congestion, Sinus Congestion

In brief

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.

Key facts

Study ID: NCT00665977
Run by: Clayton Sleep Insititute
People needed: 44
Starts: 2007-09-01
Expected to finish: 2010-07-01
Last updated by the study team: 2010-07-07

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Clayton Sleep Institute — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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