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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified ASV | Experimental | Modified ASV Enhanced ASV algorithm which includes auto-adjusting expiratory pressure. |
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| Conventional ASV | Active Comparator | Conventional ASV This is the current (predicate) ASV algorithm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Adaptive Servoventilation Device | Device | The modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | One night |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One night |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olaf Oldenburg, MD | Heart and Diabetes Centre, Ruhr University Bochum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart and Diabetes Centre, Ruhr University Bochum | Bad Oeynhausen | North Rhine-Westphalia | D-32545 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11520725 | Background | Teschler H, Dohring J, Wang YM, Berthon-Jones M. Adaptive pressure support servo-ventilation: a novel treatment for Cheyne-Stokes respiration in heart failure. Am J Respir Crit Care Med. 2001 Aug 15;164(4):614-9. doi: 10.1164/ajrccm.164.4.9908114. | |
| 12928310 | Background | Pepperell JC, Maskell NA, Jones DR, Langford-Wiley BA, Crosthwaite N, Stradling JR, Davies RJ. A randomized controlled trial of adaptive ventilation for Cheyne-Stokes breathing in heart failure. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1109-14. doi: 10.1164/rccm.200212-1476OC. Epub 2003 Aug 19. |
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All enrolled participants continued through to group assignment.
Clinic population already established on ASV therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | First Modified ASV Then Conventional ASV | Patients receive Modified ASV algorithm as therapy for 1 night, then Conventional ASV for 1 night |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All 21 patients completed the cross over study design
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified ASV/Conventional ASV | Therapy used was Modified ASV and then Conventional ASV |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Events per hour | One night |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional ASV | Intervention was conventional ASV therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diagnostic Coronary Angiogram | Cardiac disorders | Non-systematic Assessment | Coronary angiogram performed as patient (NYHA Class III) reported increased dyspnea. No relation to medical device or clinical trial. Expected event because of patient illness. |
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None to report
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Medical Affairs | ResMed | +6128841000 | adamb@resmed.com.au |
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| Conventional Adaptive Servoventilation device | Device | Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed. |
|
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| 15252739 | Background | Schadlich S, Konigs I, Kalbitz F, Blankenburg T, Busse HJ, Schutte W. [Cardiac efficiency in patients with Cheyne-Stokes respiration as a result of heart insufficiency during long-term nasal respiratory treatment with adaptive servo ventilation (AutoSet CS)]. Z Kardiol. 2004 Jun;93(6):454-62. doi: 10.1007/s00392-004-0083-3. German. |
| 18486550 | Background | Oldenburg O, Schmidt A, Lamp B, Bitter T, Muntean BG, Langer C, Horstkotte D. Adaptive servoventilation improves cardiac function in patients with chronic heart failure and Cheyne-Stokes respiration. Eur J Heart Fail. 2008 Jun;10(6):581-6. doi: 10.1016/j.ejheart.2008.04.007. Epub 2008 May 16. |
| 18763420 | Background | Javaheri S, Malik A, Smith J, Chung E. Adaptive pressure support servoventilation: a novel treatment for sleep apnea associated with use of opioids. J Clin Sleep Med. 2008 Aug 15;4(4):305-10. |
| 25413958 | Result | Oldenburg O, Spiesshofer J, Fox H, Prib N, Horstkotte D. Performance of conventional and enhanced adaptive servoventilation (ASV) in heart failure patients with central sleep apnea who have adapted to conventional ASV. Sleep Breath. 2015 Sep;19(3):795-800. doi: 10.1007/s11325-014-1083-9. Epub 2014 Nov 21. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Events per hour | One night |
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| 1 |
| 21 |
| 0 |
| 21 |
| EG001 | Modified ASV | Intervention was modified ASV therapy | 0 | 21 | 0 | 21 |
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