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

Primary Purpose

Obstructive Sleep Apnea, Nasal Congestion, Sinus Congestion

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Thermosmart & placebo

Placebo Device & Nasacort

Placebo Arm

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Nasal Congestion, Sinus congestion

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clayton Sleep Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Arm Label

Double Blind Treatment Group 2

Double Blind Treatment Goup 1

Arm Description

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.

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.

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

Outcomes

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.

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

Full Information

NCT ID

NCT00665977

First Posted

February 7, 2008

Last Updated

July 6, 2010

Sponsor

Clayton Sleep Insititute

1. Study Identification

Unique Protocol Identification Number

NCT00665977

Brief 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

Acronym

Thermosmart

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

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Clayton Sleep Insititute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

CPAP compliance will be significantly higher in both the heated humidity with Thermosmart™ and the nasal steroid phases compared to the double placebo phase. CPAP compliance will be comparably improved in the heated humidity with Thermosmart™ phase versus the nasal steroid phase. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea, Nasal Congestion, Sinus Congestion

Keywords

Obstructive Sleep Apnea, Nasal Congestion, Sinus congestion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Sham Comparator

Arm Description

Arm Title

Double Blind Treatment Group 2

Arm Type

Active Comparator

Arm Description

Arm Title

Double Blind Treatment Goup 1

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Thermosmart & placebo

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Placebo Device & Nasacort

Intervention Description

Intervention Type

Device

Intervention Name(s)

Placebo Arm

Intervention Description

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Powell, PhD

Organizational Affiliation

St. Louis University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clayton Sleep Institute

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63143

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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