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Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

This study is currently recruiting participants.
Verified March 2012 by ResMed
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01405313
First received: July 21, 2011
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Further study details as provided by ResMed:

Primary Outcome Measures:
  • Apnea/hypopnea index (AHI) [ Time Frame: Two nights ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405313

Contacts
Contact: Olaf Oldenburg, MD +49 (0) 5731 97 1258 ooldenburg@hdz-nrw.de

Locations
Germany
Heart and Diabetes Centre, Ruhr University Bochum Recruiting
Bad Oeynhausen, North Rhine Westphalia, Germany, D-32545
Principal Investigator: Olaf Oldenburg, MD            
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
Last Updated: March 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 19, 2013