Expired Study
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St. Louis, Missouri 63143


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00665977


Primary Contact:

Principal Investigator
Eric Powell, PhD
St. Louis University


Backup Contact:

N/A


Location Contact:

St. Louis, Missouri 63143
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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