ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)

September 3, 2020 updated by: Fisher and Paykel Healthcare

Prospective, Randomized, Double-blind Cross-over Study Comparing ThermoSmart® to Conventional Heated Humidity in Patients Suing Continuous Positive Airway Pressure

That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60007
        • Suburban Lung Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ≥ 18 years of age
  2. Previous diagnosis of OSA permitted, but patient must be novel to CPAP and no previous surgical intervention for OSA or treatment with an oral appliance.
  3. AHI ≥ 15 OR AHI ≥ 5 + ESS ≥ 10 OR ESS ≥ 10 + a medical co-morbidity
  4. Patient willing to give informed consent and follow study protocol.

Exclusion Criteria:

  1. Wake resting SpO2 < 90%
  2. Patient requires BiLevel PAP or supplemental oxygen
  3. The patient is medically unstable (e.g. respiratory or cardiac failure)
  4. Patient unwilling to give informed consent or follow study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP with ThermoSmart, then CPAP without ThermoSmart

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.

CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.
Device: CPAP with ThermoSmart, then CPAP without ThermoSmart

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.

CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.

Other Names:
  • ThermoSmart
Experimental: CPAP without ThermoSmart, then CPAP with ThermoSmart

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.

CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.
Device: CPAP without ThermoSmart, then CPAP with ThermoSmart

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.

CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.

Other Names:
  • ThermoSmart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CPAP Compliance
Time Frame: 1, 4 & 8 weeks
1, 4 & 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective & Objective Sleep Parameters
Time Frame: 1, 4 & 8 weeks
1, 4 & 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Collaborators

Suburban Lung Associates

Investigators

  • Principal Investigator: Clifford A Massie, PhD, Suburban Lung Asssociates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 10, 2008

First Submitted That Met QC Criteria

September 10, 2008

First Posted (Estimate)

September 11, 2008

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPHC SLA 2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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