Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Periodic Breathing Breathing-Related Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified ASV

Modified ASV Enhanced ASV algorithm which includes auto-adjusting expiratory pressure.

Group Type EXPERIMENTAL

Modified Adaptive Servoventilation Device

Intervention Type DEVICE

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

Conventional ASV

Conventional ASV This is the current (predicate) ASV algorithm.

Group Type ACTIVE_COMPARATOR

Conventional Adaptive Servoventilation device

Intervention Type DEVICE

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

Interventions

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Modified Adaptive Servoventilation Device

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

Intervention Type DEVICE

Conventional Adaptive Servoventilation device

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

Intervention Type DEVICE

Other Intervention Names

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ResMed Enhanced ASV ASVAuto ResMed AutoSet CS2 ResMed VPAP Adapt SV ResMed S9 VPAP Adapt

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No