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This study implements an extended (post marked) examination of the efficacy of a proactive auto-CPAP algorithm, which is based on the forced oscillation technique (FOT) in a sample of patients with predominantly obstructive sleep apnea. The auto-CPAP algorithm examined in this study is implemented in the medical devices prisma20A and prismaLAB (Löwenstein Medical Technology).
Patients diagnosed with obstructive sleep apnea and who comply with inclusion criteria of the study will be informed about the possibility of participation. Following informed and written consent, participants will undergo a PSG-diagnostic night according to clinical routine, followed by an auto-CPAP treatment night with a prismaLINE device (prismaLAB or prisma20A). The device settings applied in the treatment night are defined by the study protocol (see interventions). Following the auto-CPAP treatment night, study participation is completed. Any following treatment and patient care is administered according to clinical routine.
Primary and secondary outcome measures of sleep stage and respiratory event indices are evaluated at diagnostic night and auto-CPAP treatment night.
The enrollment consists of two phases. During phase 1 (training phase) 10 participants are enrolled and complete the study protocol. Phase 1 serves as a training phase to establish a common standard of data quality and acquisition. Data of the training phase are not included in the statistical analysis. Following the training phase the efficacy of the auto-CPAP algorithm is evaluated in a sample of 70 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group (auto-CPAP) | Other | Participants of this study undergo an diagnostic PSG night. The diagnostic night is followed by an auto-CPAP treatment night. Interventions: The treatment night is in line with the routine procedure of the laboratory except the following intervention: the device settings for the treatment night are applied according to the study protocol (minimal intervention). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal-Intervention - Specification of device settings | Device | - device settings for auto-CPAP treatment night: therapy mode=APAP, Pmin=5hPa,Pmax=20 hPa, Soft-Start duration <=15 min, softPAP Level is selected based on patient comfort |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index (AHI /h TST) | number of apneas and hypopneas per hour of sleep time (TST) | 2 days: change from recorded AHI in diagnostic PSG-acquistion to recorded AHI in treatment PSG-acquistion |
| Measure | Description | Time Frame |
|---|---|---|
| Obstructive Apnea-Hypopnea Index (oAHI /h TST) | number of obstructive apneas and hypopneas per hour of sleep time (TST) | 2 days: diagnostic and treatment PSG-acquistion |
| Obstructive Apnea Index (oAI /h TST) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria Statistical Evaluation:
Data of patients who completed the study protocol will be excluded from statistical analysis if one of the following criteria applies:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Regina Schäfer | Contact | 004972182830 | 23 | regina.schaefer@loewensteinmedical.de |
| Alexander Grimm | Contact | 004972182830 | 28 | alexander.grimm@loewensteinmedical.de |
| Name | Affiliation | Role |
|---|---|---|
| Winfried J. Randerath, Professor | Wissenschaftliches Institut Bethanien e.V | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wissenschaftliches Institut Bethanien e.V. | Recruiting | Solingen | 42699 | Germany |
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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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|
number of obstructive apneas per hour of sleep time (TST)
| 2 days: diagnostic and treatment PSG-acquistion |
| Central Apnea-Hypopnea Index (cAHI /h TST) | number of central apneas and hypopneas per hour of sleep time (TST) | 2 days: diagnostic and treatment PSG-acquistion |
| Oxygen Desaturation Index (ODI /h TST) | number of oxygen desaturations per hour of sleep time (TST) | 2 days: diagnostic and treatment PSG-acquistion |
| Arousal Index (ArI /h TST) | number of arousals per hour of sleep time (TST) | 2 days: diagnostic and treatment PSG-acquistion |
| Respiratory Arousal Index (ArI_resp /h TST) | number of respiratory arousals per hour of sleep time (TST) | 2 days: diagnostic and treatment PSG-acquistion |
| Snore (Snore /% TST) | Percentage of total sleep time with snoring | 2 days: diagnostic and treatment PSG-acquistion |
| Slow-wave sleep (N3 /% TST) | Percentage of total sleep time with slow wave sleep | 2 days: diagnostic and treatment PSG-acquistion |
| therapy pressure /hPa | P95, P90 and median treatment pressure (hPa) in auto-CPAP night with prismaLINE | 1 day: treatment night (auto-CPAP) |
| leakage / l/min | P95, percentage of therapy time with leakage > 50 l/min and median leakage during auto-CPAP treatment night. | 1 day: treatment night (auto-CPAP) |
| Time in Bed with oxygen saturation < 90% (SpO2 < 90 % / %TIB) | Percentage of time in Bed with an oxygen sturation < 90 % | 2 days: diagnostic and treatment PSG-acquistion |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |