Comparison of Modified With Conventional Adaptive Servoventilation Processes
Comparison of a Modified Adaptive Servoventilation With Conventional Adaptive Servoventilation Processes in Terms of Efficacy Against Complex Nocturnal Breathing Disorders
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 21, 2009
CompletedFirst Posted
Study publicly available on registry
December 23, 2009
CompletedFebruary 5, 2021
February 1, 2021
1.3 years
December 21, 2009
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Apnea/hypopnea index (AHI)
number of breathing pauses that occur each hour of sleep
1 night sleep
Secondary Outcomes (4)
Average SaO2
1 night sleep
CPAP pressure
1 night sleep
Pressure stability in presence of mask leaks
1 night sleep
Minimum SaO2
1 night sleep
Study Arms (2)
Conventional ASV
ACTIVE COMPARATORCurrent adaptive servoventilation therapy algorithm for non invasive ventilation treatment of Cheyne-Stokes Respiration.
Modified ASV
EXPERIMENTALModified adaptive servoventilation algorithm for improved treatment of nocturnal breathing disorders
Interventions
Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed
Eligibility Criteria
You may qualify if:
- + years of age
- consent in writing
- complex nocturnal breathing disorder with Cheyne-Stokes breathing and obstructive sleep apnoea
- AHI \> 15/h
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (1)
Ruhrland Hospital
Weg, Hesse, 45239, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helmut Teschler, MD
University Hospital, Ruhrland Hospital Essen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2009
First Posted
December 23, 2009
Study Start
June 1, 2008
Primary Completion
September 1, 2009
Study Completion
December 1, 2009
Last Updated
February 5, 2021
Record last verified: 2021-02