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Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention
Bu çalışma, yoğun bakımda deliryum (delirium) gelişen hastalarda ışık terapisi cihazının sirkadiyen (biyolojik) ritimleri dengelemeye etkisini incelemektedir. Çalışmaya, en az 2 gün yoğun bakımda kalması beklenen ve deliryum saptanan 18 yaş ve üzeri hastalar alınmaktadır. Faz uygulanmayan bir çalışma olup yürütülmekte ve halen katılımcı almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Patient capable of giving consent or additionally existing legal caregiver or authorized/spouse representative in case of non-consenting patients in the intensive care unit * Male and female patients with age ≥ 18 years * Expected intensive care unit stay ≥ 2 days * Positive delirium during and up to a maximum of 30 days after study inclusion (determined by CAM-ICU, at least once per shift) Exclusion Criteria: * Participation in other clinical studies during the study period and ten days before * Previous ICU treatment during the current hospital stay * Patients with psychiatric diseases * Patients with a history of stroke and known severe 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 * Amaurosis * History of sleep-related breathing disorders * History or suspicion of hypoxic brain damage * History or suspicion of elevated intracranial pressure in the last 7 days before study inclusion * Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial * The informed consent of the patient or the subject's legally acceptable representative can't be obtained in time * History of photoallergic reactions or history of visually triggered seizures * Severe eye diseases (e.g. retinopathy, glaucoma) or high sensitivity to bright light * Patients with liver cirrhosis * Patients with a probability of survival \<24h * Optic neuritis within the last 3 months * Travel across two time zones within 3 months prior to study screening * Women who are pregnant, have a positive pregnancy test, are breastfeeding or plan to become pregnant during the course of this clinical trial * Therapy-refractory blood coagulation disorder and inability to consent are exclusion criteria for a muscle biopsy