Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV
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|ClinicalTrials.gov Identifier: NCT01405313|
Recruitment Status : Completed
First Posted : July 29, 2011
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Periodic Breathing Breathing-Related Sleep Disorder||Device: Modified Adaptive Servoventilation Device Device: Conventional Adaptive Servoventilation device||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Modified Adaptive Servoventilation Therapy With Conventional Adaptive Servoventilation Therapy in Patients With Periodic Breathing|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Experimental: Modified ASV
Modified ASV Enhanced ASV algorithm which includes auto-adjusting expiratory pressure.
Device: Modified Adaptive Servoventilation Device
The modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed.
Active Comparator: Conventional ASV
Conventional ASV This is the current (predicate) ASV algorithm.
Device: Conventional Adaptive Servoventilation device
Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed.
- Apnea/Hypopnea Index (AHI) [ Time Frame: 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.
- Oxygen Desaturation Index (ODI) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405313
|Heart and Diabetes Centre, Ruhr University Bochum|
|Bad Oeynhausen, North Rhine Westphalia, Germany, D-32545|
|Principal Investigator:||Olaf Oldenburg, MD||Heart and Diabetes Centre, Ruhr University Bochum|