Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients

Study Overview
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Brief Summary
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This study compares the titration pressures achieved through two auto-titrating modalities, a new incremental fixed pressure mode versus routine auto-adjusting pressure mode, in CPAP-naïve obstructive sleep apnea patients. The aim of the study is to verify that this new modality achieves a lower titration pressure.

Detailed Description
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In patients with obstructive sleep apnea (OSA) on CPAP treatment, a CPAP titration test is usually performed to achieve the optimal pressure to maintain upper airway patency, abolish obstructive respiratory events and reduce the occurrence of adverse events. This pressure is called titration pressure. Until now, we used to perform, after an adaptation period, a single-night outpatient test with an automated device preset on auto-adjusting pressure modality (APAP). The incremental fixed pressure modality (EZ START) was initially developed to ease patients into having a positive sleep therapy experience from the very beginning. This mode gradually increases air pressure night-by-night until the preset therapeutic pressure is reached. In each good therapy session, the device performs in fixed pressure overnight and we get a real residual apnea-hypopnea index (rAHI). For this study, we will use the same device (DreamStation auto CPAP, Philips Respironics, Murrysville, PA, USA), a web-based system to telemonitor patient therapy (EncoreAnywhere) and perform for each individual patient the two modalities in a telemonitoring crossover randomized single-blind (patient) way.

Official Title
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A Telemonitoring Crossover Study Comparing a New Incremental Fixed Pressure Titration Modality Versus Auto-adjustable Titration for CPAP-naïve Obstructive Sleep Apnea Patients

Conditions
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Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Disordered Breathing, Respiration; Sleep Disorder, Respiratory Tract Disease, Sleep Disorders, Intrinsic, Sleep Wake Disorders

Intervention / Treatment
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* Device: EZ START Titration
* Device: APAP Titration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 OSA diagnosis CPAP therapy indication Exclusion Criteria: Previous CPAP therapy Severe COPD Respiratory insufficiency Obesity-hypoventilation syndrome Cardiac failure Recent cerebrovascular disease Central apnea, Cheyne Stokes or similar Important nasal insufficiency or malformation Previous pharyngeal surgery Shift work Psychosocial disability Refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EZ START Titration<br>CPAP titration test performed with an auto CPAP device preset on incremental fixed pressure modality. If the titration pressure is achieved (in a 14-day maximum period) the device will be immediately and remotely preset in CPAP modality with EZ START pressure (if any) for a 14-day period to check the titration pressure performance in a short-time period. Afterwards, the device will be remotely preset on the next modality: auto-adjusting pressure (no wash-out period). | Device: EZ START Titration<br>* The auto CPAP device gradually increases air pressure night-by-night until the preset therapeutic pressure is reached. Pressure range: from 5 to 14 cmH2O. Ramp: 4cmH2O, 20 minutes. Mask: nasal (if no contraindication). Titration pressure: fixed pressure that reduces rAHI below 10, mask leak below 10% of the session, time session above 4 hours.<br>* Other names: EncoreAnywhere;Device: APAP Titration<br>* The auto CPAP device continuously adjusts the pressure in real time to the minimum pressure needed to maintain upper airway patency at any moment. Pressure range: 5 to 14 cm H2O. Ramp: 4cmH2O, 20 minutes. Mask: nasal (if no contraindication). Titration pressure: visual analysis pressure that reduces rAHI below 10 during 90% of the session, mask leak below 10% of the session, therapeutic session above 4 hours.<br>* Other names: EncoreAnywhere;|
| Active Comparator: APAP Titration<br>CPAP titration test performed with an auto CPAP device preset on auto-adjusting pressure modality. If the titration pressure is achieved (in a 14-day maximum period) the device will be immediately and remotely preset in CPAP modality with APAP pressure (if any) for a 14-day period to check the titration pressure performance in a short-time period. Afterwards, the device will be remotely preset on the next modality: incremental fixed pressure (no wash-out period). | Device: EZ START Titration<br>* The auto CPAP device gradually increases air pressure night-by-night until the preset therapeutic pressure is reached. Pressure range: from 5 to 14 cmH2O. Ramp: 4cmH2O, 20 minutes. Mask: nasal (if no contraindication). Titration pressure: fixed pressure that reduces rAHI below 10, mask leak below 10% of the session, time session above 4 hours.<br>* Other names: EncoreAnywhere;Device: APAP Titration<br>* The auto CPAP device continuously adjusts the pressure in real time to the minimum pressure needed to maintain upper airway patency at any moment. Pressure range: 5 to 14 cm H2O. Ramp: 4cmH2O, 20 minutes. Mask: nasal (if no contraindication). Titration pressure: visual analysis pressure that reduces rAHI below 10 during 90% of the session, mask leak below 10% of the session, therapeutic session above 4 hours.<br>* Other names: EncoreAnywhere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Titration pressure | Titration pressure in any modality | 14-day maximum period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP Adherence | Adjusted adherence: days of use (%) * hours of use (mean) | 14-day period | 
| CPAP Efficacy | Residual AHI (mean) in the period | 14-day period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, Titration, Obstructive Sleep Apnea, Telemonitoring, Telemedicine