Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/2/2013 |
| Start Date: | January 2012 |
| End Date: | June 2013 |
| Contact: | Hanie Shahpari, MSc |
| Email: | hanie.shahpari@fphcare.co.nz |
| Phone: | +6495740123 |
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).
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.
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