Phase
Condition
Acute Rhinitis
Sinus Infections
Sleep Apnea Syndromes
Treatment
N/AClinical Study ID
Ages 16-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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) forat least one of the following nasal symptoms related to their sleep apnea and CPAPusage: 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
Exclusion Criteria:
Co-morbid medical condition that is either medically significant and unstable, wouldinterfere with the patient's ability to routinely use CPAP, or is a contraindicationfor use of a nasal steroid
Women who are pregnant or who may potentially become pregnant during the course of theresearch trial.
CPAP compliance over the past three weeks at screening > 5 hours/night, suggesting nocompromised CPAP usage due to adverse nasal symptoms
Wake resting SaO2 < 90%
Currently using Bi-Level therapy, supplemental oxygen with CPAP therapy, or using apressure 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™ heatedhumidity.
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 currentlytaking intranasal steroid treatment cannot wash-out of steroid treatment to beincluded nor if patients have used nasal steroid treatment while on CPAP therapy
Current upper airway tract infection, influenza, respiratory infection at time ofscreening 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 beenon a stable dose prior to CPAP therapy and willing to maintain current dose asprescribed.
Shift or rotating shift workers or individuals who routinely cannot contribute atleast 6 hours/night to sleep/attempting therapy
Additional sleep disorder that would interfere with routine use of CPAP
Study Design
Study Description
Connect with a study center
Clayton Sleep Institute
St. Louis, Missouri 63143
United StatesSite Not Available

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