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

This study has been completed.
Sponsor:
Information provided by:
Clayton Sleep Insititute
ClinicalTrials.gov Identifier:
NCT00665977
First received: February 7, 2008
Last updated: July 6, 2010
Last verified: July 2010
  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.

Condition Intervention Phase
Obstructive Sleep Apnea
Nasal Congestion
Sinus Congestion
Drug: Thermosmart & placebo
Drug: Placebo Device & Nasacort
Device: Placebo Arm
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Clayton Sleep Insititute:

Primary Outcome Measures:
  • 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nasal Symptom Assessment, Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire, PSQI, Clayton Daytime Fatigue Scale, ESS, FSS, FOSQ, Actigraphy, Sleep, and Diary/Daily Assessments [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: September 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: A
To enter into the single-blind placebo phase, subjects will be setup with a Fisher & Paykel 604 CPAP unit with a heated humidifier and "deactivated" Thermosmart™ tube, thus, only traditional heated humidity will be available. The deactivated unit will still "appear" to function with intact heated humidity settings. The CPAP machine will be set to the patient's prescribed pressure. Subjects will also be given a nasal steroid spray placebo and instructed to deliver one spray in each nostril daily.
Device: Placebo Arm
To enter into the single-blind placebo phase, subjects will be setup with a Fisher & Paykel 604 CPAP unit with a heated humidifier and "deactivated" Thermosmart™ tube, thus, only traditional heated humidity will be available. The deactivated unit will still "appear" to function with intact heated humidity settings. The CPAP machine will be set to the patient's prescribed pressure. Subjects will also be given a nasal steroid spray placebo and instructed to deliver one spray in each nostril daily.
Active Comparator: Double Blind Treatment Group 2
Visit 3 will be identical to visit 2, with the exception being the crossover of double-blind treatment. Subjects will now receive the Fisher & Paykel 604 CPAP machine with traditional heated humidity and a deactivated Thermosmart™ tube set to their prescribed pressure. Subjects will also be given the nasal steroid Nasacort AQ (triamcinolone acetonide) at a dosage of 220 mcg. They will be instructed to deliver two sprays in each nostril daily. Once again, phone follow-up will be made 7-10 days after the visit to assess compliance with study procedures and adverse events.
Drug: Placebo Device & Nasacort
Visit 3 will be identical to visit 2, with the exception being the crossover of double-blind treatment. Subjects will now receive the Fisher & Paykel 604 CPAP machine with traditional heated humidity and a deactivated Thermosmart™ tube set to their prescribed pressure. Subjects will also be given the nasal steroid Nasacort AQ (triamcinolone acetonide) at a dosage of 220 mcg. They will be instructed to deliver two sprays in each nostril daily. Once again, phone follow-up will be made 7-10 days after the visit to assess compliance with study procedures and adverse events.
Active Comparator: Double Blind Treatment Goup 1
a Fisher & Paykel 604 CPAP machine with Thermosmart™ heated humidity set at their prescribed pressure. Subjects will also be given nasal steroid placebo (purified water) and instructed to deliver two sprays in each nostril daily
Drug: Thermosmart & placebo
a Fisher & Paykel 604 CPAP machine with Thermosmart™ heated humidity set at their prescribed pressure. Subjects will also be given nasal steroid placebo (purified water) and instructed to deliver two sprays in each nostril daily

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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665977

Locations
United States, Missouri
Clayton Sleep Institute
St. Louis, Missouri, United States, 63143
Sponsors and Collaborators
Clayton Sleep Insititute
Investigators
Principal Investigator: Eric Powell, PhD St. Louis University
  More Information

No publications provided

Responsible Party: Eric Powell, PhD, Clayton Sleep Institute, LLC
ClinicalTrials.gov Identifier: NCT00665977     History of Changes
Other Study ID Numbers: F & P 07-004
Study First Received: February 7, 2008
Last Updated: July 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Clayton Sleep Insititute:
Obstructive Sleep Apnea
Nasal Congestion
Sinus congestion

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic
Triamcinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014