Status:
COMPLETED
ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)
Lead Sponsor:
Fisher and Paykel Healthcare
Collaborating Sponsors:
Suburban Lung Associates
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00751335
Start Date
August 1 2006
End Date
October 1 2008
Last Update
September 24 2020
Active Locations (1)
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1
Suburban Lung Associates
Chicago, Illinois, United States, 60007