Extended Evaluation of the Efficacy of a Proactive FOT-based Auto-CPAP Algorithm
NCT ID: NCT03070756
Last Updated: 2017-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2016-10-31
2018-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment group (auto-CPAP)
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).
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Initial diagnosis of predominant obstructive sleep apnea (percentage of central respiratory events \< 20 %)
* informed written consent
Exclusion Criteria
* Participation in another clinical trial that influences the initiation of auto-CPAP treatment by specifications of device settings or titration procedure
* acute cardiac decompensation
* severe arrhythmia
* severe hypotension, particularly in combination with intravascular volume depletion
* severe epistaxis
* high risk of barotrauma
* decompensated pulmonary conditions
* pneumothorax or pneumomediastinum
* pneumocephalus
* cranial trauma
* status following brain surgery or surgical intervention on the pituitary gland or the middle/inner ear
* acute sinus infection (sinusitis), middle ear infection (otitis media) or perforated eardrum
* dehydration
Data of patients who completed the study protocol will be excluded from statistical analysis if one of the following criteria applies:
* AHI \<= 15,0 (n/h TST) or percentage of central respiratory events \>= 20% in the second, study specific PSG-diagnostic night
* application of incorrect device settings
* insufficient data quality of PSG-acquisition
* the device was applied outside range of indication
* data of diagnostic night are not acquired as a PSG
* total time of softSTART duration exceeded 60 min
* the auto-CPAP device was restarted \>= 3 times during the treatment night. Recurrent reductions of device therapy pressure to start level (device restarts) which are applied within a time frame of \<= 5 minutes after another restart will be assigned to previous restart und therefore numbered as one. Restarts which take place before initial falling asleep will not be numbered.
* the application time of the auto-CPAP device was \<6h during treatment night
18 Years
ALL
No
Sponsors
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Heinen und Löwenstein GmbH & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Winfried J. Randerath, Professor
Role: STUDY_DIRECTOR
Wissenschaftliches Institut Bethanien e.V
Locations
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Wissenschaftliches Institut Bethanien e.V.
Solingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Winfried J. Randerath, Professor
Role: primary
Marcel Treml, PhD
Role: backup
Other Identifiers
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16-pLINE-AC-1
Identifier Type: -
Identifier Source: org_study_id