Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

ResMed21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Periodic Breathing Breathing-Related Sleep Disorder

Interventions

Modified Adaptive Servoventilation DeviceDEVICE

The modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed.

Conventional Adaptive Servoventilation deviceDEVICE

Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Heart and Diabetes Centre, Ruhr University Bochum

Bad Oeynhausen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Apnea/Hypopnea Index (AHI)

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.

Time frame: One night

Secondary Outcomes

Oxygen Desaturation Index (ODI)

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.

Time frame: One night

Data from ClinicalTrials.gov

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