Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV
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About
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.
Full 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.
Enrollment
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
21 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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