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

NCT00665977 | Completed Phase 3

• 1 other identifier: F & P 07-004
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.CPAP compliance will be comparably improved in the heated humidity with Thermosmart™ phase versus the nasal steroid phase.
3. 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. 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.

Conditions

Obstructive Sleep Apnea; Nasal Congestion; Sinus Congestion

Keywords

Obstructive Sleep Apnea; Nasal Congestion; Sinus congestion

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Nasal Symptom Assessment, Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire, PSQI, Clayton Daytime Fatigue Scale, ESS, FSS, FOSQ, Actigraphy, Sleep, and Diary/Daily Assessments

  8 weeks

Study Arms (3)

A

SHAM COMPARATOR

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

Double Blind Treatment Group 2

ACTIVE COMPARATOR

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

Double Blind Treatment Goup 1

ACTIVE COMPARATOR

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

Interventions

Thermosmart & placebo DRUG

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

Double Blind Treatment Goup 1

Placebo Device & Nasacort DRUG

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.

Double Blind Treatment Group 2

Placebo Arm DEVICE

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.

A

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Clayton Sleep Insititute: lead

Study Sites (1)

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Nasal Obstruction

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Eric Powell, PhD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: April 24, 2008
• Study Start: September 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

US (1)