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Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01405313
First Posted: July 29, 2011
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ResMed
July 21, 2011
July 29, 2011
September 20, 2012
March 20, 2017
March 20, 2017
July 2011
September 2011   (Final data collection date for primary outcome measure)
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.
AHI [ Time Frame: Two nights ]
Physiological sleep signals including SpO2, respiratory effort and nasal flow, will be recorded, analysed and reported in the form of an index per hour of sleep.
Complete list of historical versions of study NCT01405313 on ClinicalTrials.gov Archive Site
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.
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.
Not Provided
Not Provided
 
Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV
Comparison of Modified Adaptive Servoventilation Therapy With Conventional Adaptive Servoventilation Therapy in Patients With Periodic Breathing
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Periodic Breathing
  • Breathing-Related Sleep Disorder
  • 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
  • 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
  • Experimental: Modified ASV
    Modified ASV Enhanced ASV algorithm which includes auto-adjusting expiratory pressure.
    Intervention: Device: Modified Adaptive Servoventilation Device
  • Active Comparator: Conventional ASV
    Conventional ASV This is the current (predicate) ASV algorithm.
    Intervention: Device: Conventional Adaptive Servoventilation device

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01405313
MA231210
No
Not Provided
Plan to Share IPD: No
ResMed
ResMed
Not Provided
Principal Investigator: Olaf Oldenburg, MD Heart and Diabetes Centre, Ruhr University Bochum
ResMed
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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