Extended Evaluation of the Efficacy of a Proactive FOT-based Auto-CPAP Algorithm
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|ClinicalTrials.gov Identifier: NCT03070756|
Recruitment Status : Unknown
Verified December 2017 by Heinen und Löwenstein GmbH & Co. KG.
Recruitment status was: Recruiting
First Posted : March 6, 2017
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Minimal-Intervention - Specification of device settings||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extended Evaluation of the Efficacy of a Proactive FOT-based Auto-CPAP Algorithm in Patients With Predominantly Obstructive Sleep Apnea|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||March 2018|
treatment group (auto-CPAP)
Participants of this study undergo an diagnostic PSG night. The diagnostic night is followed by an auto-CPAP treatment night.
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
Other Name: Specification of device settings
- Apnea-Hypopnea Index (AHI /h TST) [ Time Frame: 2 days: change from recorded AHI in diagnostic PSG-acquistion to recorded AHI in treatment PSG-acquistion ]number of apneas and hypopneas per hour of sleep time (TST)
- Obstructive Apnea-Hypopnea Index (oAHI /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]number of obstructive apneas and hypopneas per hour of sleep time (TST)
- Obstructive Apnea Index (oAI /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]number of obstructive apneas per hour of sleep time (TST)
- Central Apnea-Hypopnea Index (cAHI /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]number of central apneas and hypopneas per hour of sleep time (TST)
- Oxygen Desaturation Index (ODI /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]number of oxygen desaturations per hour of sleep time (TST)
- Arousal Index (ArI /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]number of arousals per hour of sleep time (TST)
- Respiratory Arousal Index (ArI_resp /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]number of respiratory arousals per hour of sleep time (TST)
- Snore (Snore /% TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]Percentage of total sleep time with snoring
- Slow-wave sleep (N3 /% TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]Percentage of total sleep time with slow wave sleep
- therapy pressure /hPa [ Time Frame: 1 day: treatment night (auto-CPAP) ]P95, P90 and median treatment pressure (hPa) in auto-CPAP night with prismaLINE
- leakage / l/min [ Time Frame: 1 day: treatment night (auto-CPAP) ]P95, percentage of therapy time with leakage > 50 l/min and median leakage during auto-CPAP treatment night.
- Time in Bed with oxygen saturation < 90% (SpO2 < 90 % / %TIB) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]Percentage of time in Bed with an oxygen sturation < 90 %
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070756
|Contact: Regina Schäfer||004972182830 ext firstname.lastname@example.org|
|Contact: Alexander Grimm||004972182830 ext email@example.com|
|Wissenschaftliches Institut Bethanien e.V.||Recruiting|
|Solingen, Germany, 42699|
|Contact: Winfried J. Randerath, Professor 004921263 ext 6001 firstname.lastname@example.org|
|Contact: Marcel Treml, PhD 00492126366 ext 61 email@example.com|
|Principal Investigator: Winfried J. Randerath, Professor|
|Sub-Investigator: Wiebke Dorn, MD|
|Study Director:||Winfried J. Randerath, Professor||Wissenschaftliches Institut Bethanien e.V|