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

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

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

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: CPAP with ThermoSmart, then CPAP without ThermoSmart
* Device: CPAP without ThermoSmart, then CPAP with ThermoSmart


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP with ThermoSmart, then CPAP without ThermoSmart<br>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. | Device: CPAP with ThermoSmart, then CPAP without ThermoSmart<br>* 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.<br>* Other names: ThermoSmart;|
| Experimental: CPAP without ThermoSmart, then CPAP with ThermoSmart<br>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. | Device: CPAP without ThermoSmart, then CPAP with ThermoSmart<br>* 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.<br>* Other names: ThermoSmart;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP Compliance |  | 1, 4 & 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective & Objective Sleep Parameters |  | 1, 4 & 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure