Comparison of Modified With Conventional Adaptive Servoventilation Processes

Cheyne-Stokes Respiration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037439
• Other study ID #: MAEssenASV
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: February 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cheyne-Stokes Respiration
• Periodic Breathing
• Respiratory Aspiration

Intervention

Device:
• Adaptive Servo-controlled Ventilation (ASV)
Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed

Locations

Country	Name	City	State
Germany	Ruhrland Hospital	Weg	Essen

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea/hypopnea index (AHI)	number of breathing pauses that occur each hour of sleep	1 night sleep
Secondary	Average SaO2	average percentage of oxygen saturation in the blood	1 night sleep
Secondary	CPAP pressure	Continuous Positive Airway Pressure requirement for elimination of nocturnal breathing disorders	1 night sleep
Secondary	Pressure stability in presence of mask leaks	How much the CPAP pressure varies when mask leak occurs	1 night sleep
Secondary	Minimum SaO2	The minimum percentage of oxygen saturation recorded in the blood	1 night sleep