Clinical trial NCT00665977: Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure
Official title: Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea
Nasal Congestion
Sinus Congestion
Keywords: Obstructive Sleep Apnea
Nasal Congestion
Sinus congestion
Lead sponsor: Clayton Sleep Insititute
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

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 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

Primary outcomes:
measure: Although an exact & universal definition of CPAP compliance has not been determined. Compliance will be tracked by the CPAP unit and downloaded into an analysis program for review at each visit.
timeFrame: 8 weeks
Secondary outcomes:
measure: Nasal Symptom Assessment, Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire, PSQI, Clayton Daytime Fatigue Scale, ESS, FSS, FOSQ, Actigraphy, Sleep, and Diary/Daily Assessments
timeFrame: 8 weeks
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
Study officials:
affiliation: St. Louis University
name: Eric Powell, PhD
role: PRINCIPAL_INVESTIGATOR
References: