Comparison of Modified With Conventional Adaptive Servoventilation Processes
- Conditions
- Cheyne-Stokes RespirationPeriodic Breathing
- Interventions
- Device: Adaptive Servo-controlled Ventilation (ASV)
- Registration Number
- NCT01037439
- Lead Sponsor
- ResMed
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 18+ years of age
- consent in writing
- complex nocturnal breathing disorder with Cheyne-Stokes breathing and obstructive sleep apnoea
- AHI > 15/h
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Modified ASV Adaptive Servo-controlled Ventilation (ASV) Modified adaptive servoventilation algorithm for improved treatment of nocturnal breathing disorders Conventional ASV Adaptive Servo-controlled Ventilation (ASV) Current adaptive servoventilation therapy algorithm for non invasive ventilation treatment of Cheyne-Stokes Respiration.
- Primary Outcome Measures
Name Time Method Apnea/hypopnea index (AHI) 1 night sleep number of breathing pauses that occur each hour of sleep
- Secondary Outcome Measures
Name Time Method Average SaO2 1 night sleep average percentage of oxygen saturation in the blood
Pressure stability in presence of mask leaks 1 night sleep How much the CPAP pressure varies when mask leak occurs
CPAP pressure 1 night sleep Continuous Positive Airway Pressure requirement for elimination of nocturnal breathing disorders
Minimum SaO2 1 night sleep The minimum percentage of oxygen saturation recorded in the blood
Trial Locations
- Locations (1)
Ruhrland Hospital
🇩🇪Weg, Essen, Germany