Breathing-Related Sleep Disorder, Periodic Breathing
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEModified Adaptive Servoventilation Device
The modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed.
DEVICEConventional Adaptive Servoventilation device
Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed.
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea/Hypopnea Index (AHI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Desaturation Index (ODI) | 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. |
Countries
Germany
Participant flow
Recruitment details
Clinic population already established on ASV therapy.
Pre-assignment details
All enrolled participants continued through to group assignment.
Participants by arm
| Arm | Count |
|---|---|
| Modified ASV/Conventional ASV Therapy used was Modified ASV and then Conventional ASV | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Modified ASV/Conventional ASV |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 69.9 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment Germany | 21 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 1 / 21 | 0 / 21 |
Outcome results
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.
Time frame: One night
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified ASV AHI | Apnea/Hypopnea Index (AHI) | 3.9 Events per hour | Standard Deviation 4.7 |
| Conventional ASV AHI | Apnea/Hypopnea Index (AHI) | 6.4 Events per hour | Standard Deviation 10.9 |
p-value: 0.022t-test, 1 sided
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.
Time frame: One night
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified ASV AHI | Oxygen Desaturation Index (ODI) | 5.2 Events per hour | Standard Deviation 5.3 |
| Conventional ASV AHI | Oxygen Desaturation Index (ODI) | 8.2 Events per hour | Standard Deviation 11.8 |
p-value: 0.016t-test, 1 sided