Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

Not Applicable

Completed

Interventions: Device: Conventional Adaptive Servoventilation device
Device: Modified Adaptive Servoventilation Device

Brief Summary: 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.

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Conventional ASV	Conventional Adaptive Servoventilation device	Conventional ASV This is the current (predicate) ASV algorithm.
Modified ASV	Modified Adaptive Servoventilation Device	Modified ASV Enhanced ASV algorithm which includes auto-adjusting expiratory pressure.

Primary Outcome Measures

Name	Time	Method
Apnea/Hypopnea Index (AHI)	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

Name	Time	Method
Oxygen Desaturation Index (ODI)	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.