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

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.

Study Overview

• Status: Completed
• Conditions: Cheyne-Stokes Respiration; Periodic Breathing
• Intervention / Treatment: Device: Adaptive Servo-controlled Ventilation (ASV)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Essen
    • Weg, Essen, Germany, 45239
      • Ruhrland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional ASV; Current adaptive servoventilation therapy algorithm for non invasive ventilation treatment of Cheyne-Stokes Respiration.	Device: Adaptive Servo-controlled Ventilation (ASV); Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed; Other Names: AutoSet CS2; Adapt SV
Experimental: Modified ASV; Modified adaptive servoventilation algorithm for improved treatment of nocturnal breathing disorders	Device: Adaptive Servo-controlled Ventilation (ASV); Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed; Other Names: AutoSet CS2; Adapt SV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea/hypopnea index (AHI)	number of breathing pauses that occur each hour of sleep	1 night sleep

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average SaO2	average percentage of oxygen saturation in the blood	1 night sleep
CPAP pressure	Continuous Positive Airway Pressure requirement for elimination of nocturnal breathing disorders	1 night sleep
Pressure stability in presence of mask leaks	How much the CPAP pressure varies when mask leak occurs	1 night sleep
Minimum SaO2	The minimum percentage of oxygen saturation recorded in the blood	1 night sleep

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Helmut Teschler, MD, University Hospital, Ruhrland Hospital Essen

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 21, 2009
• First Submitted That Met QC Criteria: December 21, 2009
• First Posted (Estimate): December 23, 2009

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Aspiration; Cheyne-Stokes Respiration
• Other Study ID Numbers: MAEssenASV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No