Back to resultsThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP with ThermoSmart, then CPAP without ThermoSmart
CPAP without ThermoSmart, then CPAP with ThermoSmart
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age
- 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.
- AHI ≥ 15 OR AHI ≥ 5 + ESS ≥ 10 OR ESS ≥ 10 + a medical co-morbidity
- Patient willing to give informed consent and follow study protocol.
Exclusion Criteria:
- Wake resting SpO2 < 90%
- Patient requires BiLevel PAP or supplemental oxygen
- The patient is medically unstable (e.g. respiratory or cardiac failure)
- Patient unwilling to give informed consent or follow study protocol.
Sites / Locations
- Suburban Lung Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CPAP with ThermoSmart, then CPAP without ThermoSmart
CPAP without ThermoSmart, then CPAP with ThermoSmart
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
CPAP Compliance
Secondary Outcome Measures
Subjective & Objective Sleep Parameters
Full Information
NCT ID
NCT00751335
First Posted
September 10, 2008
Last Updated
September 3, 2020
Sponsor
Fisher and Paykel Healthcare
Collaborators
Suburban Lung Associates
1. Study Identification
Unique Protocol Identification Number
NCT00751335
Brief Title
ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)
Official Title
Prospective, Randomized, Double-blind Cross-over Study Comparing ThermoSmart® to Conventional Heated Humidity in Patients Suing Continuous Positive Airway Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
Collaborators
Suburban Lung Associates
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP with ThermoSmart, then CPAP without ThermoSmart
Arm Type
Experimental
Arm Description
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.
Arm Title
CPAP without ThermoSmart, then CPAP with ThermoSmart
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CPAP with ThermoSmart, then CPAP without ThermoSmart
Other Intervention Name(s)
ThermoSmart
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
CPAP without ThermoSmart, then CPAP with ThermoSmart
Other Intervention Name(s)
ThermoSmart
Intervention Description
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.
Primary Outcome Measure Information:
Title
CPAP Compliance
Time Frame
1, 4 & 8 weeks
Secondary Outcome Measure Information:
Title
Subjective & Objective Sleep Parameters
Time Frame
1, 4 & 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years of age
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.
AHI ≥ 15 OR AHI ≥ 5 + ESS ≥ 10 OR ESS ≥ 10 + a medical co-morbidity
Patient willing to give informed consent and follow study protocol.
Exclusion Criteria:
Wake resting SpO2 < 90%
Patient requires BiLevel PAP or supplemental oxygen
The patient is medically unstable (e.g. respiratory or cardiac failure)
Patient unwilling to give informed consent or follow study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clifford A Massie, PhD
Organizational Affiliation
Suburban Lung Asssociates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suburban Lung Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.sublung.com
Description
Suburban Lung Associates
URL
http://fphcare.com
Description
Fisher & Paykel Healthcare
URL
http://www.chicagosleepgroup.com
Description
Chicago Sleep Group
Learn more about this trial
ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)
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