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

Sleep Apnea, Obstructive Clinical Trial

Official title:

Prospective, Randomized, Double-blind Cross-over Study Comparing ThermoSmart® to Conventional Heated Humidity in Patients Suing Continuous Positive Airway Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751335
• Other study ID #: FPHC SLA 2008
• Status: Completed
• Phase: N/A
• Start date: August 2006
• Est. completion date: October 2008

Study information

• Verified date: September 2020
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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 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.

Locations

Country	Name	City	State
United States	Suburban Lung Associates	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare	Suburban Lung Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP Compliance		1, 4 & 8 weeks
Secondary	Subjective & Objective Sleep Parameters		1, 4 & 8 weeks

External Links

•   Chicago Sleep Group
•   Fisher & Paykel Healthcare
•   Suburban Lung Associates