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 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT02143661
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients with age ≥ 18 years
* Expected intensive Care unit stay ≥ 48 hours
* Invasive mechanical ventilation or non-invasive mechanical ventilation (with positive ventilation pressure \>6 hours/day and high flow \>30 liters) on the day of intensive care unit admission
Exclusion Criteria:
* Participation in other clinical studies 10 days before study inclusion and during the study period
* Patients with psychiatric diseases
* Patients with a history of stroke and known residual cognitive deficits
* Patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary resuscitation followed by therapeutic hypothermia during entire hospital stay
* Analphabetism
* Anacusis or Hypoacusis with hearing aid device, Amaurosis
* Non-German speaking
* Allergies to any substance of the electrode fixing material
* Lacking willingness to save and hand out data within the study
* Accommodation in an institution due to an official or judicial order
* History of sleep disorders
* History or suspicion of hypoxic brain damage (e.g. intracranial bleeding)
* History or suspicion of elevated intracranial pressure in the last 7 days before study inclusion
* Patients with an open chest after cardiac surgery
* The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
* Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02143661
Study Brief:
Protocol Section:
NCT02143661