Comparison of Modified With Conventional Adaptive Servoventilation Processes

Study Overview
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Brief Summary
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The objective of this study is to compare the modified adaptive servoventilation control algorithm of the with the standardised algorithms of routinely-used servoventilation processes (AutoSet CS2) in terms of the effect on obstructive and central events. The aim is to normalise breathing during sleep and hence eliminate the sleep-related breathing disorder, resulting in even more effective treatment of nocturnal breathing disorders in patients with cardiovascular diseases and sleep apnoea, to ensure optimum therapy success.

Detailed Description
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Patients with cardiovascular disorders frequently suffer from sleep-related respiratory disorders (SRRD), such as obstructive sleep apnea (OSA) or a specific form of central sleep apnea, Cheyne-Stokes breathing (CSB, periodic breathing). However there is also a significant incidence of complex nocturnal breathing disorders, with both obstructive and central components. Sleep-related breathing disorders of this kind cause decreases in arterial oxygen saturation through brief hypopneas and apneas. Disturbed breathing also causes the patient to wake frequently during the night (arousals), usually during the hyperventilatory phase of CSB. Repeated arousals cause fragmentation of sleep, and therefore a deep sleep deficit. This leads to increased sleepiness during the day and impaired cognitive performance. Previous studies have shown that Cheyne-Stokes breathing can be treated effectively with adaptive servoventilation. An enhancement to the routinely used algorithm (AutoSet CS2) has been created which allows the algorithm to differentiate between obstructive events and Cheyne-Stokes breathing, and better respond to apneas and hypopneas to eliminate the sleep-related breathing disorder and normalise breathing during sleep.

Official Title
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Comparison of a Modified Adaptive Servoventilation With Conventional Adaptive Servoventilation Processes in Terms of Efficacy Against Complex Nocturnal Breathing Disorders

Conditions
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Periodic Breathing, Cheyne-Stokes Respiration

Intervention / Treatment
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* Device: Adaptive Servo-controlled Ventilation (ASV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18+ years of age consent in writing complex nocturnal breathing disorder with Cheyne-Stokes breathing and obstructive sleep apnoea AHI > 15/h Exclusion Criteria: acute cardiac decompensation acute myocardial infarct within the last 3 months post-resuscitation condition within the last 3 months post-stroke condition with difficulty in swallowing or persisting hemiparesis abuse of medication, alcohol or drugs pregnancy known to be suffering from a tumour

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: Conventional ASV<br>Current adaptive servoventilation therapy algorithm for non invasive ventilation treatment of Cheyne-Stokes Respiration. | Device: Adaptive Servo-controlled Ventilation (ASV)<br>* Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed<br>* Other names: Adapt SV;|
| Experimental: Modified ASV<br>Modified adaptive servoventilation algorithm for improved treatment of nocturnal breathing disorders | Device: Adaptive Servo-controlled Ventilation (ASV)<br>* Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed<br>* Other names: Adapt SV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea/hypopnea index (AHI) | number of breathing pauses that occur each hour of sleep | 1 night sleep | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average SaO2 | average percentage of oxygen saturation in the blood | 1 night sleep | 
| CPAP pressure | Continuous Positive Airway Pressure requirement for elimination of nocturnal breathing disorders | 1 night sleep | 
| Pressure stability in presence of mask leaks | How much the CPAP pressure varies when mask leak occurs | 1 night sleep | 
| Minimum SaO2 | The minimum percentage of oxygen saturation recorded in the blood | 1 night sleep |