Comparison of Modified With Conventional Adaptive Servoventilation Processes

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ResMed

Status

Completed

Conditions

Periodic Breathing
Cheyne-Stokes Respiration

Treatments

Device: Adaptive Servo-controlled Ventilation (ASV)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01037439
MAEssenASV

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups

Conventional ASV
Active Comparator group
Description:
Current adaptive servoventilation therapy algorithm for non invasive ventilation treatment of Cheyne-Stokes Respiration.
Treatment:
Device: Adaptive Servo-controlled Ventilation (ASV)
Modified ASV
Experimental group
Description:
Modified adaptive servoventilation algorithm for improved treatment of nocturnal breathing disorders
Treatment:
Device: Adaptive Servo-controlled Ventilation (ASV)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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