ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)

Fisher & Paykel Healthcare

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Device: CPAP without ThermoSmart, then CPAP with ThermoSmart; Device: CPAP with ThermoSmart, then CPAP without ThermoSmart

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00751335

FPHC SLA 2008

Details and patient eligibility

About

That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years of age
2. 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.
3. AHI ≥ 15 OR AHI ≥ 5 + ESS ≥ 10 OR ESS ≥ 10 + a medical co-morbidity
4. Patient willing to give informed consent and follow study protocol.

Exclusion criteria

1. Wake resting SpO2 < 90%
2. Patient requires BiLevel PAP or supplemental oxygen
3. The patient is medically unstable (e.g. respiratory or cardiac failure)
4. Patient unwilling to give informed consent or follow study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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79 participants in 2 patient groups

CPAP with ThermoSmart, then CPAP without ThermoSmart

Experimental group

Description:

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.

Treatment:

Device: CPAP with ThermoSmart, then CPAP without ThermoSmart

CPAP without ThermoSmart, then CPAP with ThermoSmart

Experimental group

Description:

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.

Treatment:

Device: CPAP without ThermoSmart, then CPAP with ThermoSmart