Delirium Confusional State

8

Review clinical trials related to Delirium Confusional State. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Effects of Different Types of Music Therapy Combined With Mindful Breathing on Delirium, Pain, and Anxiety in ICU Patients

Delirium is the most common and severe neuropsychiatric complication in the Intensive Care Unit (ICU), with an incidence as high as 87% in the United States, 75.6% in medical ICUs in Taiwan, and 41.7% in surgical ICUs, with patients developing delirium an average of 2.6 days after admission. Delirium is associated with prolonged mechanical ventilation, increased complications, higher in-hospital mortality, greater psychological burden on family members, and elevated clinical pressure on healthcare staff. The National Institute for Health and Care Excellence (NICE) guidelines recommend prioritizing non-pharmacological interventions for delirium prevention, among which music intervention has emerged as one of the most promising strategies due to its low risk, low cost, and feasibility in the ICU setting. Although several international studies have supported its potential benefits, evidence remains inconclusive. Mindfulness-based approaches represent another non-pharmacological strategy that intentionally directs attention to present-moment bodily sensations; mindful breathing exercises are particularly suitable for ICU patients, as they only require patients to adopt a comfortable position in bed and focus on each inhalation and exhalation under guidance, quickly restoring awareness to present bodily experience. Incorporating mindful breathing before and after music listening may therefore facilitate emotional regulation and present-moment awareness, enhancing patient engagement and attentional focus during the intervention. Existing delirium prevention studies in Taiwan have predominantly employed multicomponent care bundles, leaving a gap in empirical evidence regarding music as a standalone intervention. Moreover, scholars have highlighted that musical preference and cultural background influence patients' psychological responses to music, underscoring the importance of cultural appropriateness. In response to this gap, the present study proposes a music intervention combining classical music and Taiwan-localized music with mindful breathing exercises, aiming to examine the effects on ICU delirium incidence and severity, compare the effectiveness of classical versus Taiwan-localized music, and explore the potential benefits on patient anxiety and pain, with the hope of providing a culturally informed, evidence-based music repertoire to guide clinical practice in Taiwan.

Participants needed: 51
Trial details
Age: 20+Biological sex: AllType: InterventionalSponsor: Chimei Medical CenterUpdated: Jun 3, 2026
Eligibility criteria

Adults aged 20 years or older who can communicate verbally or in writing [+3]

Positive delirium screening at ICU admission [+2]

Status: Not yet recruiting

Phenobarbital for Agitated Delirium

The goal of this clinical trial is to test whether the medication phenobarbital is as effective for treating agitated delirium among adult patients admitted to the intensive care unit. Agitated delirium is a condition involving confusion and impulsiveness which is dangerous to both patients and healthcare providers. The main questions this trial aims to answer include: * Can phenobarbital decrease the amount of time patients with agitated delirium spend in the intensive care unit and the hospital? * Does phenobarbital decrease the amount of additional calming medications patients with agitated delirium need? Researchers in this study will compare phenobarbital to other medications commonly used to treat agitated delirium. Participants will be monitored closely to make sure they remain safe and to measure how well their agitation and confusion are managed while they are in the ICU.

Participants needed: 150
Trial details
Phase: Phase 3Age: 21+Biological sex: AllType: InterventionalSponsor: Duke UniversityUpdated: Apr 23, 2026Locations: 1
Eligibility criteria

Adult Patients identified by providers to have agitated or hyperactive delirium

Pregnancy [+3]

Status: Recruiting

Using Virtual Reality to Improve Medical Training

As the U.S. population ages, future physicians must be prepared to care for older adults with multiple health conditions and complex needs. This study will test whether cinematic virtual reality (VR)-an immersive, interactive learning tool-is more effective than traditional lectures in helping medical students learn about geriatric care. Students who complete the VR training will experience realistic patient scenarios that show what can go wrong in medical care and learn how to apply osteopathic principles to improve outcomes. Researchers will compare students' performance on a clinical skills assessment and explore their experiences with the VR training. The goal is to determine whether cinematic virtual reality can better prepare students for residency and improve their ability to provide compassionate, high-quality care for older adults.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ohio UniversityUpdated: Apr 21, 2026Locations: 1
Eligibility criteria

Not listed

Status: Not yet recruiting

Lorazepam for Delirium Prevention in Critically Ill Patients With High Anttila-Index

Delirium is a neuropsychiatric syndrome characterized by cognitive and attentional deficits, circadian rhythm, emotional and psychomotor dysregulation. It is frequently encountered in patients admitted to an Intensive Care Unit (ICU) with a prevalence of 20-80% and associated with higher morbidity and mortality, prolonged hospitalization and cognitive impairment after hospitalization. Alcoholism is an important risk factor that favors the development of delirium and a common comorbidity in patients admitted to the ICU. Patients with alcohol use disorders can develop a withdrawal syndrome after cessation of alcohol consumption. The most severe form of alcohol withdrawal is the alcohol withdrawal delirium, which is characterized by a profound state of confusion. Early recognition and treatment significantly diminish severe complications of alcohol withdrawal delirium, including mortality. The common pharmacological prevention and therapy of alcohol withdrawal syndrome is the administration of benzodiazepines, which have the potential to prevent or mitigate alcohol withdrawal delirium. In the ICU setting the diagnosis of alcoholism based on self-report can be unreliable and complicated by acute illness. The Anttila-Index is a parameter calculated from the carbohydrate-deficient transferrin and the gamma-glutamyltransferase. It has a high sensitivity and specificity for excessive alcohol consumption. Therefore, the Anttila-Index of patients admitted to the ICU could help identify patients at risk for developing delirium due to alcoholism or due to alcoholism in combination with other risk factors. Schreiber et al. recently (October 2023) found significantly higher Anttila-Index in patients with delirium on a medical ICU. The investigators postulate that this also applies to the patients admitted to the mixed (medical and surgical) ICU at the University Hospital Basel (USB), since surgery is an additional crucial risk factor for delirium development. Hypothesis: ICU delirium can be reduced by careful preventive administration of lorazepam in patients admitted to the ICU with an Anttila-Index at or above the cutoff value of four.

Participants needed: 260
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, Basel, SwitzerlandUpdated: Feb 27, 2026
Eligibility criteria

Emergency/unplanned admission to the ICU [+4]

Pre-existing delirium [+6]

Status: Not yet recruiting

Delirium and Heart Failure

Biomarkers such as Systemic Immune-Inflammation Index (SII) and TG/Glucose Ratio (TyG) have shown promise in predicting delirium, reflecting the roles of inflammation and metabolic disturbances in its pathophysiology. This study aims to compare the predictive value of SII and the TyG ratio among other chemical and physiological biomarkers for diagnosing delirium and detecting its severity in older adults with heart failure. These biomarkers reflect different pathophysiological pathways implicated in delirium, including inflammation, cardiovascular stress, and metabolic dysfunction. By evaluating their individual and combined predictive abilities, this research seeks to identify potential tools for early identification of patients at high risk for delirium

Participants needed: 100
Trial details
Age: 60+Biological sex: AllType: ObservationalSponsor: Ain Shams UniversityUpdated: Dec 24, 2025Locations: 1
Eligibility criteria

cognitive impairment [+5]

Status: Not yet recruiting

Point-of-Care AI Assistance and Critical Care Outcomes: A Randomized Trial

This is a prospective, unmasked, randomized, multicenter clinical trial evaluating the impact of point-of-care large language model (LLM)-based decision support on diagnostic accuracy and clinical outcomes in adult medical intensive care unit (MICU) patients. Consecutive adult ICU admissions at participating community hospitals (initially MetroWest Medical Center and St. Vincent Hospital) will be screened for eligibility. Eligible patients will be randomized 1:1 to standard care or an AI-assisted group. In both arms, initial evaluation and management will follow usual practice. For patients randomized to AI assistance, de-identified admission data (history and physical, labs, imaging reports, and other relevant documentation) will be formatted and submitted to a state-of-the-art LLM (ChatGPT-5) at the time of admission. The AI-generated differential diagnosis and therapeutic recommendations will be provided to the admitting team for consideration. For the standard care arm, LLM output will be generated but not shared with clinicians. After discharge, a masked chart review will determine the "ground truth" primary diagnosis and extract outcomes including: Primary Outcome - a composite of medical errors (from time of ICU admission through day 7 of ICU stay, or ICU discharge, whichever comes first); Secondary Outcomes - 90-day mortality, ICU and hospital length of stay, and ventilator-free days.

Participants needed: 1,000
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: MetroWest Artificial Intelligence Research WorkgroupUpdated: Dec 18, 2025Locations: 1
Eligibility criteria

Adult patients (≥ 18 years) admitted to the medical intensive care unit (MICU) a... [+2]

Transfers to the MICU from outside hospitals, operating room, or post-anesthesia... [+5]

Status: Recruiting

Clinical Trial Protocol: Alzheimer's Dementia Underlying Encephalopathy

The goal of this clinical trial is to determine if utilizing the Quest AD-Detect blood test, while patient's are hospitalized for a cognitive diagnosis (such as delirium or encephalopathy), will result in an earlier diagnosis of underlying Alzheimer's disease. * Will this blood test have the ability to distinguish between Alzheimer's disease and other causes of cognitive impairment in the inpatient setting? * Neurology Clinic will complete a 6-month post-hospitalization follow up with patients who have had the Quest AD-Detect Alzheimer's Disease blood test completed while they were inpatient to discuss the risk assessment portfolio

Participants needed: 30
Trial details
Age: 60-90Biological sex: AllType: InterventionalSponsor: Covenant Health, USUpdated: Oct 29, 2025Locations: 6
Eligibility criteria

Ages 60 to 90 years old [+2]

Age under 60 years [+1]

Status: Not yet recruiting

Management of Non-pharmacologic Delirium With the Use of a Nursing-led E-health Project: a Randonmized Controlled Trial

Application of an action protocol focused on the application of non-pharmacological interventions for managing delirium in the process of prevention, diagnosis and treatment, evaluated using an e-health intervention, with a tablet to introduce on it the data about the prevention, diagnostic and treatment process of each recluted patient, in the Igualada Hospital Center, once a day.

Participants needed: 65
Trial details
Age: 80-130Biological sex: AllType: InterventionalSponsor: Universitat de LleidaUpdated: May 29, 2025Locations: 1
Eligibility criteria

Age over 80 years [+3]

Age under 80 years [+1]