effect of heated humidity with thermosmart™ compared to an intranasal steroid in improving compliance and nasal symptoms in patients using continuous positive airway pressure

Conditions: Obstructive Sleep Apnea; Nasal Congestion; Sinus Congestion

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.

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.

Eligibility 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

Keywords: obstructive sleep apnea nasal congestion sinus congestion