Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT03070756
Eligibility Criteria:
Inclusion Criteria:
* Apnea-Hypopnea Index (AHI) \> 15,0 (n/h Total Sleep Time)
* Initial diagnosis of predominant obstructive sleep apnea (percentage of central respiratory events \< 20 %)
* informed written consent
Exclusion Criteria:
* missing informed written consent
* 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
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:
* non adherence to in-/exclusion criteria
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03070756
Study Brief:
Protocol Section:
NCT03070756