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

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: CPAP with ThermoSmart, then CPAP without ThermoSmart; Device: CPAP without ThermoSmart, then CPAP with ThermoSmart

• Registration Number: NCT00751335
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-09-10
• Study First Submitted QC: 2008-09-10
• Study First Posted: 2008-09-11
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2020-09
• Results First Submitted: 2020-09-03
• Results First Submitted QC: 2020-09-03
• Last Update Submitted: 2020-09-03
• Results First Posted: 2020-09-24
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CPAP with ThermoSmart, then CPAP without ThermoSmart	CPAP with ThermoSmart, then CPAP without ThermoSmart	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.
CPAP without ThermoSmart, then CPAP with ThermoSmart	CPAP without ThermoSmart, then CPAP with ThermoSmart	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.

Primary Outcome Measures

Name	Time	Method
CPAP Compliance	1, 4 & 8 weeks

Secondary Outcome Measures

Name	Time	Method
Subjective & Objective Sleep Parameters	1, 4 & 8 weeks

Trial Locations

Locations (1)

Suburban Lung Associates; 🇺🇸 Chicago, Illinois, United States