An interventional study of Minimal-Intervention - Specification of device settings in Obstructive Sleep Apnea, sponsored by Heinen und Löwenstein GmbH & Co. KG. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-29.
Sponsored by Heinen und Löwenstein GmbH & Co. KG · Not applicable, Interventional, and Treatment
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.
1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's planned enrollment of 80 is above the median of 51 across 966 interventional studies indexed under Apnea.
Browse Apnea studies →Heinen und Löwenstein GmbH & Co. KG is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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).
Device: Minimal-Intervention - Specification of device settings
- 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
Also known as: Specification of device settings
Apnea-Hypopnea Index (AHI /h TST)
number of apneas and hypopneas per hour of sleep time (TST)
Time frame: 2 days: change from recorded AHI in diagnostic PSG-acquistion to recorded AHI in treatment PSG-acquistion
Obstructive Apnea-Hypopnea Index (oAHI /h TST)
number of obstructive apneas and hypopneas per hour of sleep time (TST)
Time frame: 2 days: diagnostic and treatment PSG-acquistion
Obstructive Apnea Index (oAI /h TST)
number of obstructive apneas per hour of sleep time (TST)
Time frame: 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)
Time frame: 2 days: diagnostic and treatment PSG-acquistion
Oxygen Desaturation Index (ODI /h TST)
number of oxygen desaturations per hour of sleep time (TST)
Time frame: 2 days: diagnostic and treatment PSG-acquistion
Arousal Index (ArI /h TST)
number of arousals per hour of sleep time (TST)
Time frame: 2 days: diagnostic and treatment PSG-acquistion
Respiratory Arousal Index (ArI_resp /h TST)
number of respiratory arousals per hour of sleep time (TST)
Time frame: 2 days: diagnostic and treatment PSG-acquistion
Snore (Snore /% TST)
Percentage of total sleep time with snoring
Time frame: 2 days: diagnostic and treatment PSG-acquistion
Slow-wave sleep (N3 /% TST)
Percentage of total sleep time with slow wave sleep
Time frame: 2 days: diagnostic and treatment PSG-acquistion
therapy pressure /hPa
P95, P90 and median treatment pressure (hPa) in auto-CPAP night with prismaLINE
Time frame: 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.
Time frame: 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 %
Time frame: 2 days: diagnostic and treatment PSG-acquistion
Plan to share: No
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This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Heinen und Löwenstein GmbH & Co. KG