An interventional study of Modified Adaptive Servoventilation Device and Conventional Adaptive Servoventilation device in Periodic Breathing and Breathing-Related Sleep Disorder, sponsored by ResMed. Completed at 1 site in Germany. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-03-20.
Sponsored by ResMed · Not applicable, Interventional, and Treatment
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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This study's enrollment of 21 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
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Exclusion Criteria:
Modified ASV Enhanced ASV algorithm which includes auto-adjusting expiratory pressure.
Device: Modified Adaptive Servoventilation Device
Conventional ASV This is the current (predicate) ASV algorithm.
Device: Conventional Adaptive Servoventilation device
The modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed.
Also known as: ResMed Enhanced ASV, ASVAuto
Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed.
Also known as: ResMed AutoSet CS2, ResMed VPAP Adapt SV, ResMed S9 VPAP Adapt
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
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
Clinic population already established on ASV therapy.
| Milestone | First Modified ASV Then Conventional ASV |
|---|---|
| Started | 21 |
| Completed | 21 |
| Not completed | 0 |
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.
| Events per hour | Modified ASV AHI | Conventional ASV AHI |
|---|---|---|
| Apnea/Hypopnea Index (AHI) | 3.9 ± 4.7 | 6.4 ± 10.9 |
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.
| Events per hour | Modified ASV ODI | Conventional ASV ODI |
|---|---|---|
| Oxygen Desaturation Index (ODI) | 5.2 ± 5.3 | 8.2 ± 11.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional ASV | — | 1/21 (4.8%) | 0/21 (0%) |
| Modified ASV | — | 0/21 (0%) | 0/21 (0%) |
| Event | Conventional ASV | Modified ASV |
|---|---|---|
| Diagnostic Coronary AngiogramCardiac disorders | 1/21 | 0/21 |
All 21 patients completed the cross over study design
| Age, Categorical(Participants) | Modified ASV/Conventional ASV |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 17 |
| Age, Continuous(years) | Modified ASV/Conventional ASV |
|---|---|
| Mean | 69.9 ± 8.7 |
| Sex: Female, Male(Participants) | Modified ASV/Conventional ASV |
|---|---|
| Female | 2 |
| Male | 19 |
| Region of Enrollment(participants) | Modified ASV/Conventional ASV |
|---|---|
| Germany | 21 |
Plan to share: No
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