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Comparison of Modified With Conventional Adaptive Servoventilation Processes

Primary Purpose

Periodic Breathing, Cheyne-Stokes Respiration

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Adaptive Servo-controlled Ventilation (ASV)
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodic Breathing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ruhrland Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional ASV

Modified ASV

Arm Description

Current adaptive servoventilation therapy algorithm for non invasive ventilation treatment of Cheyne-Stokes Respiration.

Modified adaptive servoventilation algorithm for improved treatment of nocturnal breathing disorders

Outcomes

Primary Outcome Measures

Apnea/hypopnea index (AHI)
number of breathing pauses that occur each hour of sleep

Secondary Outcome Measures

Average SaO2
average percentage of oxygen saturation in the blood
CPAP pressure
Continuous Positive Airway Pressure requirement for elimination of nocturnal breathing disorders
Pressure stability in presence of mask leaks
How much the CPAP pressure varies when mask leak occurs
Minimum SaO2
The minimum percentage of oxygen saturation recorded in the blood

Full Information

First Posted
December 21, 2009
Last Updated
February 2, 2021
Sponsor
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT01037439
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodic Breathing, Cheyne-Stokes Respiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional ASV
Arm Type
Active Comparator
Arm Description
Current adaptive servoventilation therapy algorithm for non invasive ventilation treatment of Cheyne-Stokes Respiration.
Arm Title
Modified ASV
Arm Type
Experimental
Arm Description
Modified adaptive servoventilation algorithm for improved treatment of nocturnal breathing disorders
Intervention Type
Device
Intervention Name(s)
Adaptive Servo-controlled Ventilation (ASV)
Other Intervention Name(s)
AutoSet CS2, Adapt SV
Intervention Description
Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed
Primary Outcome Measure Information:
Title
Apnea/hypopnea index (AHI)
Description
number of breathing pauses that occur each hour of sleep
Time Frame
1 night sleep
Secondary Outcome Measure Information:
Title
Average SaO2
Description
average percentage of oxygen saturation in the blood
Time Frame
1 night sleep
Title
CPAP pressure
Description
Continuous Positive Airway Pressure requirement for elimination of nocturnal breathing disorders
Time Frame
1 night sleep
Title
Pressure stability in presence of mask leaks
Description
How much the CPAP pressure varies when mask leak occurs
Time Frame
1 night sleep
Title
Minimum SaO2
Description
The minimum percentage of oxygen saturation recorded in the blood
Time Frame
1 night sleep

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Teschler, MD
Organizational Affiliation
University Hospital, Ruhrland Hospital Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruhrland Hospital
City
Weg
State/Province
Essen
ZIP/Postal Code
45239
Country
Germany

12. IPD Sharing Statement

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Comparison of Modified With Conventional Adaptive Servoventilation Processes

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