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Completed

NCT Number: NCT01037439

Comparison of Modified With Conventional Adaptive Servoventilation Processes

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruhrland Hospital

Weg, Hesse, 45239, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adaptive Servo-controlled Ventilation (ASV)

Device

Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed

Other names: AutoSet CS2, Adapt SV

Primary outcomes

  1. Apnea/hypopnea index (AHI)

    Time frame: 1 night sleep

    number of breathing pauses that occur each hour of sleep

Secondary outcomes

  1. Average SaO2

    Time frame: 1 night sleep

    average percentage of oxygen saturation in the blood

  2. CPAP pressure

    Time frame: 1 night sleep

    Continuous Positive Airway Pressure requirement for elimination of nocturnal breathing disorders

  3. Pressure stability in presence of mask leaks

    Time frame: 1 night sleep

    How much the CPAP pressure varies when mask leak occurs

  4. Minimum SaO2

    Time frame: 1 night sleep

    The minimum percentage of oxygen saturation recorded in the blood

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 23, 2009
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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