Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure

Last updated: July 6, 2010
Sponsor: Clayton Sleep Insititute
Overall Status: Completed

Phase

3

Condition

Acute Rhinitis

Sinus Infections

Sleep Apnea Syndromes

Treatment

N/A

Clinical Study ID

NCT00665977
F & P 07-004
  • Ages 16-65
  • All Genders

Study 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.

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

Total Participants: 44
Study Start date:
September 01, 2007
Estimated Completion Date:
July 31, 2010

Study 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.

Connect with a study center

  • Clayton Sleep Institute

    St. Louis, Missouri 63143
    United States

    Site Not Available

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