Clinical trial NCT01037439: Comparison of Modified With Conventional Adaptive Servoventilation Processes
Official title: Comparison of a Modified Adaptive Servoventilation With Conventional Adaptive Servoventilation Processes in Terms of Efficacy Against Complex Nocturnal Breathing Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodic Breathing
Cheyne-Stokes Respiration
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Apnea/hypopnea index (AHI)
timeFrame: 1 night sleep
Secondary outcomes:
measure: Average SaO2
timeFrame: 1 night sleep
measure: CPAP pressure
timeFrame: 1 night sleep
measure: Pressure stability in presence of mask leaks
timeFrame: 1 night sleep
measure: Minimum SaO2
timeFrame: 1 night sleep
Other outcomes:
Locations:
city: Weg
country: Germany
facility: Ruhrland Hospital
state: Essen
Study officials:
affiliation: University Hospital, Ruhrland Hospital Essen
name: Helmut Teschler, MD
role: PRINCIPAL_INVESTIGATOR
References: