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Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by ResMed.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
ResMed Identifier:
First received: July 21, 2011
Last updated: March 13, 2012
Last verified: March 2012
This study will determine if modified adaptive servoventilation (ASV) is as effective as the conventional ASV in treating periodic breathing. The study will determine if the modified ASV reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive airway pressure compared to conventional ASV.

Condition Intervention
Periodic Breathing
Breathing-Related Sleep Disorder
Device: Modified Adaptive Servoventilation Device
Device: Conventional Adaptive Servoventilation device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Modified Adaptive Servoventilation Therapy With Conventional Adaptive Servoventilation Therapy in Patients With Periodic Breathing

Further study details as provided by ResMed:

Primary Outcome Measures:
  • Apnea/hypopnea index (AHI) [ Time Frame: Two nights ]
    Physiological sleep signals including pulse oximetry (SpO2), respiratory effort and nasal flow, will be recorded, analysed and reported in the form of an index per hour of sleep.

Secondary Outcome Measures:
  • Oxygen desaturation index (ODI) [ Time Frame: Two nights ]
    Oxygen desaturation index based on SpO2 measurement of number of dips per hour of sleep will be recorded, analysed and reported.

Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified ASV Device: Modified Adaptive Servoventilation Device
The modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed.
Other Name: ResMed Enhanced ASV
Active Comparator: Conventional ASV Device: Conventional Adaptive Servoventilation device
Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed.
Other Names:
  • ResMed AutoSet CS2
  • ResMed VPAP Adapt SV

Detailed Description:

Adaptive servoventilation (ASV) is a type of non-invasive ventilation which ameliorates central sleep and/or mixed apnea and periodic breathing. Previous studies in the field have shown that treatment of periodic breathing with ASV improves sleep quality and quality of life. In reducing central apneas, ASV reduces overall arousal index, and increases overall slow wave sleep and rapid eye movement (REM) sleep more than oxygen, continuous positive airway pressure or bi-level treatments. ASV can also more effectively reduce central apnea and overall apnea/hypopnea index (AHI) in patients on long-term opiates, and appears to effectively treat Complex Sleep Apnea Syndrome. It is more effective than other forms of non-invasive ventilation for patients with central and/or mixed apnea or periodic breathing, and is better tolerated.

This is a prospective, randomised, crossover, observational study. Subjects will spend one night on conventional ASV and one night on modified ASV with full in-lab polysomnography (PSG) during therapy on both nights.

Objective and subjective parameters will be recorded and analysed.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 21+ years old
  • Chronic ResMed ASV therapy patient
  • Current ASV therapy for at least 4 weeks
  • Able to understand fully the study information and participation requirements
  • Provide signed informed consent

Exclusion Criteria:

  • Acute cardiac decompensation
  • Acute myocardial infarction within last 3 months
  • Resuscitation within last 3 months
  • Stroke with swallowing disorders or persistent hemiparesis
  • Blood pressure test at end expiratory pressure (EEP) 10cmH2O not passed
  • Untreated restless legs syndrome
  • Alcohol or drug abuse
  • Known cancer
  • Pregnancy
  • Conditions that could interfere with patients participating in and completing the protocol and/or the investigator deems their enrolment unsuitable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01405313

Heart and Diabetes Centre, Ruhr University Bochum
Bad Oeynhausen, North Rhine Westphalia, Germany, D-32545
Sponsors and Collaborators
Principal Investigator: Olaf Oldenburg, MD Heart and Diabetes Centre, Ruhr University Bochum
  More Information

Responsible Party: ResMed Identifier: NCT01405313     History of Changes
Other Study ID Numbers: MA231210 
Study First Received: July 21, 2011
Last Updated: March 13, 2012

Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders processed this record on February 20, 2017