Sleep Apnea, Obstructive
Conditions
Keywords
Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure, ICON, ThermoSmart, SensAwake
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).
Interventions
DEVICEConventional CPAP Therapy
HC244 devices without Thermosmart or SensAwake
DEVICEFixed pressure ICON™ without ThermoSmart™
Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™
DEVICEAuto ICON™ with SensAwake™ and ThermoSmart™
APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™
Sponsors
Sleep Health Centers
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software. | On day 90 after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit. | On day 90 after randomization |
Countries
United States
Participant flow
Pre-assignment details
This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.
Participants by arm
| Arm | Count |
|---|---|
| Conventional CPAP Fisher & Paykel HC244™
Conventional CPAP Therapy: HC244 devices without Thermosmart or SensAwake | 0 |
| CPAP Without Humidification Fixed pressure ICON™ without ThermoSmart™
Fixed pressure ICON™ without ThermoSmart™: Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™ | 0 |
| APAP With All Technologies Auto ICON™ with SensAwake™ and ThermoSmart™
Auto ICON™ with SensAwake™ and ThermoSmart™: APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™ | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.
Secondary
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
Population: This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.