Status:
COMPLETED
Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure
Lead Sponsor:
Clayton Sleep Insititute
Conditions:
Obstructive Sleep Apnea
Nasal Congestion
Eligibility:
All Genders
16-65 years
Phase:
PHASE3
Brief 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 i...
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 improvin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00665977
Start Date
September 1 2007
End Date
July 1 2010
Last Update
July 7 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clayton Sleep Institute
St Louis, Missouri, United States, 63143