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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. |
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| Group 2 | Active Comparator | Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APAP A (ResMed AirSense AutoSet) | Device | Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Apnoea-Hypopnoea-Index (AHI) | AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour). | 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex) |
| Mean Oxygen Desaturation Index (ODI) | Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour | 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B. |
| Measure | Description | Time Frame |
|---|---|---|
| Obstructive Apnoea Index (OAI) | Number of obstructive apnoeas per hour of nights sleep, Events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
| Central Apnoea Index (CAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingo Fietz, Prof | Charite Center of Sleep Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Sleep Medicine, Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | APAP A, Then APAP B | Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B 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 |
| FG001 | APAP B, Then APAP A | Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Apnoea-Hypopnoea-Index (AHI) | AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour). | 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. | Posted | Mean | Standard Deviation | events/hour | 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex) |
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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 | APAP A (AirSense) | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Dr med Ingo Fietze | Charite Department of Sleepmedizin | +49 30 450 513 122 | ingo.fietze@charite.de |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| APAP B (Apex iCH Auto) | Device | Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events |
|
|
Number of central apnoeas during hours of sleep, events/hour
| 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
| Mixed Apnoea Index (MAI) | Number of obstructive and central apnoeas per hours of nights sleep, Events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
| Hypopnoea-Index HI | Number of Hypopnoeas per hour of nights sleep, Events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
| Respiratory Effort Related Arousals RERAs | Number of RERAs per hour of nights sleep, Events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
| Flow Limitation (%) | Percent of flow-limited breaths in relation to the overall breaths at night. | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
| Mean O2 Saturation | Mean blood oxygen Saturation, % | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Neck Size | Mean | Standard Deviation | cm |
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| waist-to-hip ratio | Mean | Standard Deviation | ratio |
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| OG001 | APAP B (Apex iCH Auto) | Patients in the "APAP B, then APAP A" group will use APAP B on the first night of the evaluation and APAP A on the second night. Afterwards the outcome will be calculated for all 20 patients having used treatment APAP A. 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 |
|
|
|
| Primary | Mean Oxygen Desaturation Index (ODI) | Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour | Posted | Mean | Standard Deviation | events/hour | 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B. |
|
|
|
|
| Secondary | Obstructive Apnoea Index (OAI) | Number of obstructive apnoeas per hour of nights sleep, Events/hour | Posted | Mean | Standard Deviation | events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
|
|
|
| Secondary | Central Apnoea Index (CAI) | Number of central apnoeas during hours of sleep, events/hour | Posted | Mean | Standard Deviation | events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
|
|
|
| Secondary | Mixed Apnoea Index (MAI) | Number of obstructive and central apnoeas per hours of nights sleep, Events/hour | Posted | Mean | Standard Deviation | events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
|
|
|
| Secondary | Hypopnoea-Index HI | Number of Hypopnoeas per hour of nights sleep, Events/hour | Posted | Mean | Standard Deviation | events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
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| Secondary | Respiratory Effort Related Arousals RERAs | Number of RERAs per hour of nights sleep, Events/hour | Posted | Mean | Standard Deviation | events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
|
|
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| Secondary | Flow Limitation (%) | Percent of flow-limited breaths in relation to the overall breaths at night. | Posted | Mean | Standard Deviation | % overall breaths | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
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| Secondary | Mean O2 Saturation | Mean blood oxygen Saturation, % | Posted | Mean | Standard Deviation | % total hemoglobin | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | APAP B (Apex) | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| t-test, 1 sided | 0.134 | Mean Difference (Net) | 2.69 | 2-Sided | Non-Inferiority | We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen). |