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Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01405313
First received: July 21, 2011
Last updated: January 30, 2017
Last verified: September 2012
  Purpose
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: No masking
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: One night ]
    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. Apnea-Hypopnea Index is calculated counting all apneas (reduction of respiratory flow by >90% for at least 10 seconds) plus all hypopneas (reduction of respiratory flow by >30% for at least 10 seconds with a 4% SpO2 reduction) divided by hours of sleep.


Secondary Outcome Measures:
  • Oxygen Desaturation Index (ODI) [ Time Frame: One night ]
    Oxygen desaturation index based on SpO2 measurement of number of dips (number of times per hour of sleep that SpO2 Drops by at least 3% below the basic value) will be recorded, analysed and reported.


Enrollment: 21
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified ASV
Modified ASV Enhanced ASV algorithm which includes auto-adjusting expiratory pressure.
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 Names:
  • ResMed Enhanced ASV
  • ASVAuto
Active Comparator: Conventional ASV
Conventional ASV This is the current (predicate) ASV algorithm.
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
  • ResMed S9 VPAP Adapt

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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01405313

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

Publications:

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01405313     History of Changes
Other Study ID Numbers: MA231210
Study First Received: July 21, 2011
Results First Received: September 20, 2012
Last Updated: January 30, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Wake Disorders
Parasomnias
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on March 23, 2017