Obstructive Sleep Apnea
Conditions
Brief summary
Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.
Interventions
DEVICEAPAP A (ResMed AirSense AutoSet)
Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
DEVICEAPAP B (Apex iCH Auto)
Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males aged ≥ 18 years * Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry * Naive to CPAP therapy * Participants willing and able to give written informed consent
Exclusion criteria
* Participants requiring Bi-level PAP * Participants requiring supplemental oxygen * Participants who are pregnant * Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Apnoea-Hypopnoea-Index (AHI) | 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex) | AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour). |
| Mean Oxygen Desaturation Index (ODI) | 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B. | Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mixed Apnoea Index (MAI) | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | Number of obstructive and central apnoeas per hours of nights sleep, Events/hour |
| Hypopnoea-Index HI | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | Number of Hypopnoeas per hour of nights sleep, Events/hour |
| Obstructive Apnoea Index (OAI) | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | Number of obstructive apnoeas per hour of nights sleep, Events/hour |
| Flow Limitation (%) | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | Percent of flow-limited breaths in relation to the overall breaths at night. |
| Mean O2 Saturation | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | Mean blood oxygen Saturation, % |
| Respiratory Effort Related Arousals RERAs | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | Number of RERAs per hour of nights sleep, Events/hour |
| Central Apnoea Index (CAI) | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | Number of central apnoeas during hours of sleep, events/hour |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Patients will be randomised to either APAP A, then APAP B or APAP B, then APAP A. Patients in APAP A, then APAP B will use APAP A on the first night of the evaluation, and APAP B on the second night. Patients in APAP B, then APAP A will use APAP B on the first night of the evaluation and APAP A on the second night.
APAP A (ResMed AirSense AutoSet): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
APAP B (Apex iCH Auto): Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 12.5 |
| Body Mass Index (BMI) | 31.1 kg/m2 STANDARD_DEVIATION 5.3 |
| Neck Size | 41.1 cm STANDARD_DEVIATION 3.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
| waist-to-hip ratio | 1.01 ratio STANDARD_DEVIATION 0.06 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Mean Apnoea-Hypopnoea-Index (AHI)
AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).
Time frame: 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)
Population: 20 patients have used APAP A, for which the primary outcome was calculated. The same 20 patients have used APAP B for which the Primary outcome was calculated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP A (AirSense Auto Set) | Mean Apnoea-Hypopnoea-Index (AHI) | 6.21 events/hour | Standard Deviation 6.73 |
| APAP B (Apex iCH Auto) | Mean Apnoea-Hypopnoea-Index (AHI) | 7.45 events/hour | Standard Deviation 7.57 |
Comparison: Comparison of AHI/ oxygen desaturation index (ODI) of Device A compared with Device B.~Efficacy is defined as a residual AHI and ODI on each night of the trial. PSG scored AHI and ODI will be collected on both trial nights (excluding the ramp period); and compared using the Paired T testp-value: 0.537t-test, 1 sided
p-value: 0.05t-test, 1 sided
Primary
Mean Oxygen Desaturation Index (ODI)
Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour
Time frame: 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP A (AirSense Auto Set) | Mean Oxygen Desaturation Index (ODI) | 7.94 events/hour | Standard Deviation 8.1 |
| APAP B (Apex iCH Auto) | Mean Oxygen Desaturation Index (ODI) | 10.63 events/hour | Standard Deviation 9.5 |
p-value: 0.205t-test, 1 sided
p-value: 0.134t-test, 1 sided
Secondary
Central Apnoea Index (CAI)
Number of central apnoeas during hours of sleep, events/hour
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP A (AirSense Auto Set) | Central Apnoea Index (CAI) | 2.36 events/hour | Standard Deviation 4.08 |
| APAP B (Apex iCH Auto) | Central Apnoea Index (CAI) | 2.51 events/hour | Standard Deviation 5.14 |
Secondary
Flow Limitation (%)
Percent of flow-limited breaths in relation to the overall breaths at night.
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP A (AirSense Auto Set) | Flow Limitation (%) | 49.25 % overall breaths | Standard Deviation 27.61 |
| APAP B (Apex iCH Auto) | Flow Limitation (%) | 43.16 % overall breaths | Standard Deviation 22.59 |
Secondary
Hypopnoea-Index HI
Number of Hypopnoeas per hour of nights sleep, Events/hour
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP A (AirSense Auto Set) | Hypopnoea-Index HI | 3.17 events/hour | Standard Deviation 3.8 |
| APAP B (Apex iCH Auto) | Hypopnoea-Index HI | 5.49 events/hour | Standard Deviation 5.51 |
Secondary
Mean O2 Saturation
Mean blood oxygen Saturation, %
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP A (AirSense Auto Set) | Mean O2 Saturation | 94.210 % total hemoglobin | Standard Deviation 2.414 |
| APAP B (Apex iCH Auto) | Mean O2 Saturation | 93.680 % total hemoglobin | Standard Deviation 2.192 |
Secondary
Mixed Apnoea Index (MAI)
Number of obstructive and central apnoeas per hours of nights sleep, Events/hour
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP A (AirSense Auto Set) | Mixed Apnoea Index (MAI) | 0.115 events/hour | Standard Deviation 0.514 |
| APAP B (Apex iCH Auto) | Mixed Apnoea Index (MAI) | 0.220 events/hour | Standard Deviation 0.744 |
Secondary
Obstructive Apnoea Index (OAI)
Number of obstructive apnoeas per hour of nights sleep, Events/hour
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP A (AirSense Auto Set) | Obstructive Apnoea Index (OAI) | 0.580 events/hour | Standard Deviation 1.525 |
| APAP B (Apex iCH Auto) | Obstructive Apnoea Index (OAI) | 0.885 events/hour | Standard Deviation 1.668 |
Secondary
Respiratory Effort Related Arousals RERAs
Number of RERAs per hour of nights sleep, Events/hour
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APAP A (AirSense Auto Set) | Respiratory Effort Related Arousals RERAs | 0.0 events/hour | Standard Deviation 0 |
| APAP B (Apex iCH Auto) | Respiratory Effort Related Arousals RERAs | 2.81 events/hour | Standard Deviation 12.81 |