N/A
Completed N=79
ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)
Sleep Apnea, Obstructive
Source: ClinicalTrials.gov NCT00751335 ↗
Enrolled (actual)
79
Serious AEs
—
Results posted
Sep 2020
Primary outcomePrimary: CPAP Compliance
Summary
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CPAP Compliance |
— | — |
| SECONDARY Subjective & Objective Sleep Parameters |
— | — |
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. Informational only — not medical advice.