N/A
N=79
ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00751335 ↗Enrolled (actual)
79
Serious AEs
—
Results posted
Sep 2020
Primary outcome: Primary: CPAP Compliance
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPAP with ThermoSmart, then CPAP without ThermoSmart (Device); CPAP without ThermoSmart, then CPAP with ThermoSmart (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fisher and Paykel Healthcare
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CPAP Compliance |
— | — |
| SECONDARY Subjective & Objective Sleep Parameters |
— | — |
Summary
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.
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.
Data sourced from ClinicalTrials.gov (NCT00751335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.