Back to resultsComparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
Primary Purpose
Sleep Apnea, Obstructive
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventional CPAP Therapy
Fixed pressure ICON™ without ThermoSmart™
Auto ICON™ with SensAwake™ and 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, ICON, ThermoSmart, SensAwake
Eligibility Criteria
Inclusion Criteria:
- Aged 18-70 years with moderate-to-severe OSA (Apnea Hypopnea Index equal to or greater than 10 per hour).
- Successful titration Polysomnography (PSG).
- Fluency in both written and spoken English.
Exclusion Criteria:
- Participants prescribed and fitted with any PAP device in the past 2 years.
- Contraindicated for CPAP or AutoCPAP therapy.
- Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
- Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
- Previous surgery for OSA or snoring or any surgery of the mouth, nose, sinuses or airways.
- If SensAwake™ or ThermoSmart™ was disabled on the treatment arm (or conversely) during the study protocol.
- If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
- If the physician objects to their patient taking part in the study.
Sites / Locations
- Sleep HealthCenters
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Conventional CPAP
CPAP without Humidification
APAP with all technologies
Arm Description
Fisher & Paykel HC244™
Fixed pressure ICON™ without ThermoSmart™
Auto ICON™ with SensAwake™ and ThermoSmart™
Outcomes
Primary Outcome Measures
Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.
Secondary Outcome Measures
Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit.
Full Information
NCT ID
NCT01517763
First Posted
January 17, 2012
Last Updated
May 19, 2019
Sponsor
Fisher and Paykel Healthcare
Collaborators
Sleep Health Centers
1. Study Identification
Unique Protocol Identification Number
NCT01517763
Brief Title
Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
The site closed down, therefore the study has been terminated.
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
Collaborators
Sleep Health Centers
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard care with a fixed pressure Continuous Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).
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, ICON, ThermoSmart, SensAwake
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional CPAP
Arm Type
Placebo Comparator
Arm Description
Fisher & Paykel HC244™
Arm Title
CPAP without Humidification
Arm Type
Active Comparator
Arm Description
Fixed pressure ICON™ without ThermoSmart™
Arm Title
APAP with all technologies
Arm Type
Experimental
Arm Description
Auto ICON™ with SensAwake™ and ThermoSmart™
Intervention Type
Device
Intervention Name(s)
Conventional CPAP Therapy
Intervention Description
HC244 devices without Thermosmart or SensAwake
Intervention Type
Device
Intervention Name(s)
Fixed pressure ICON™ without ThermoSmart™
Intervention Description
Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™
Intervention Type
Device
Intervention Name(s)
Auto ICON™ with SensAwake™ and ThermoSmart™
Intervention Description
APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™
Primary Outcome Measure Information:
Title
Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.
Time Frame
On day 90 after randomization
Secondary Outcome Measure Information:
Title
Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit.
Time Frame
On day 90 after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-70 years with moderate-to-severe OSA (Apnea Hypopnea Index equal to or greater than 10 per hour).
Successful titration Polysomnography (PSG).
Fluency in both written and spoken English.
Exclusion Criteria:
Participants prescribed and fitted with any PAP device in the past 2 years.
Contraindicated for CPAP or AutoCPAP therapy.
Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
Previous surgery for OSA or snoring or any surgery of the mouth, nose, sinuses or airways.
If SensAwake™ or ThermoSmart™ was disabled on the treatment arm (or conversely) during the study protocol.
If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
If the physician objects to their patient taking part in the study.
Facility Information:
Facility Name
Sleep HealthCenters
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
We'll reach out to this number within 24 hrs