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Delirium clinical trials

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NCT ID: NCT06232317 Enrolling by invitation - Surgery Clinical Trials

Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients

Start date: December 9, 2023
Phase: N/A
Study type: Interventional

This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.

NCT ID: NCT06117761 Enrolling by invitation - Delirium Clinical Trials

Combined Activity and Cognitive Intervention for ICU Survivors

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

This mixed-methods study comprising a 3-arm pilot RCT and a qualitative study aims to investigate the preliminary effects and feasibility of a home-based combined activity and cognitive intervention for ICU survivors (COMBAT-ICU). Adopting a 3-arm design with COMBAT-ICU, exercise and attention placebo study arms will enable us to evaluate the added effects, if any, of the novel combined intervention compared with the standard exercise-only rehabilitation strategy and attention placebo. Data triangulation from quantitative and qualitative aspects can facilitate result interpretation. The study's objectives are: 1. To evaluate the preliminary effects of the COMBAT-ICU intervention for ICU survivors on PICS, physical, mental and cognitive outcomes, HRQoL, unplanned re-hospitalisation rate, and mortality. 2. To explore the feasibility and acceptability of the COMBAT-ICU intervention and ICU survivors' intervention engagement experience. The hypothesis of the first objective is that upon completion of the COMBAT-ICU intervention, ICU survivors will have reduced PICS, improved physical function, mental health, cognition and HRQoL, and reduced unplanned readmissions and mortality compared with the exercise and attention placebo groups at post-intervention and 3 months thereafter. While the hypothesis of the second objective is that the COMBAT-ICU intervention is feasible and acceptable for ICU survivors.

NCT ID: NCT06063161 Enrolling by invitation - Parkinson Disease Clinical Trials

Music Therapy to Prevent Hospital-acquired Delirium in Parkinson's Disease and Dementia With Lewy Bodies

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test whether a music therapy intervention (MT) prevents hospital-acquired delirium (HaD) in patients with Parkinson's disease (PD) and Dementia with Lewy Bodies (DLB). Delirium is defined as a mental state in which you are confused, disoriented, and not able to think or remember clearly. It can start suddenly and is usually temporary. It is common among patients with PD/DLB during hospitalization. We are conducting a randomized controlled feasibility pilot study of music therapy (MT) in patients with PD/DLB in the inpatient acute hospital setting. We are testing if receiving music therapy lowers the risk of delirium, compared to other interventions. We are also testing if music therapy lowers the need for certain restraints and medications during the hospitalization. Participants admitted to UMass Memorial Medical Center will be invited to participate. Participants will be asked to undergo a music therapy intervention for 30 minutes 3 times per week, and to listen to personalized music playlists for 60 minutes 4 times per week. Participants will be assessed for HaD every 24 hours, and will undergo additional surveys and questionnaires. Researchers will compare the music therapy intervention to two another comparison groups: one group assigned to listen to music on their own, and one group assigned to receive only standard treatments. About one-third of the participants will be assigned to each of the three study groups.

NCT ID: NCT05864677 Enrolling by invitation - Critical Illness Clinical Trials

Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery

Cereb-POD
Start date: January 15, 2023
Phase: N/A
Study type: Interventional

Postoperative delirium (POD) and postoperative neuropsychological dysfunction are frequently noted in critically ill patients undergoing elective or emergency surgery and treated in the intensive care unit (ICU). Delirium is a serious complication that prolongs hospital stay and contributes to poor outcomes and increased risk of death. The pathomechanisms of delirium are still not very well recognized and there are several theories that seem to explain it. The most important pathomechanisms of delirium are associated with cerebral ischaemia, disorders in acetylcholinergic system, disorders in neuronal plasticity and oxidative stress. Cerebrolysin, a mixture of various peptides obtained from the structural proteins of the pig's brain, possesses strong antioxidative and neuronal protective properties. Cerebrolysin is recommended to treat patients with dementia, after cerebral ischemia and after brain trauma. It has been documented that Cerebrolysin reduces the severity of secondary brain damage after ischemia, improving neuronal plasticity and then cognitive function, and reducing severity of oxidative stress. Based on these properties it can be speculated that Cerebrolysin may reduce the risk of postoperative delirium in patients undergoing elective surgery, which are associated with a high risk of postoperative delirium.

NCT ID: NCT05453929 Enrolling by invitation - Clinical trials for Lumbar Spine Disease

Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery

Start date: September 16, 2021
Phase: N/A
Study type: Interventional

The effect of deep neuromuscular blockade (NMB) during spine surgery reduced postoperative pain and bleeding in recent studies. Therefore by reducing these two factors, which were the contributing factors for postoperative delirium, deep NMB is expected to reduce the postoperative delirium. This study was designed to determine whether the deep NMB lowered the incidence of delirium after lumbar surgery.

NCT ID: NCT05431595 Enrolling by invitation - Delirium Clinical Trials

Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy

Start date: July 19, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

To examine the effects of haloperidol, chlorpromazine, valproic acid and placebo, in conjunction with standardized non-pharmacologic interventions, in the first line treatment of agitated delirium in hospitalized patients with cancer. This double-blind, randomized clinical trial aims to provide evidence on various therapeutic options for palliating delirium, thereby reducing delirium-related distress and ultimately alleviating suffering.

NCT ID: NCT05220761 Enrolling by invitation - Delirium Clinical Trials

Family Assessment of Pediatric Delirium

FAM-CAPD
Start date: August 9, 2021
Phase:
Study type: Observational

In this study the investigators will assess the validity, reliability and acceptability of utilizing family members to complete a delirium screen using the Cornell Assessment of Pediatric Delirium (CAPD).

NCT ID: NCT04973150 Enrolling by invitation - Ophthalmology Clinical Trials

Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Participants (preschool children), because their cognitive ability and anti pressure ability are obviously weaker than adults, most of the children who have this kind of operation and anesthesia stressors will have perioperative anxiety. After eye surgery, they need to bandage their eyes with gauze (single or double), so that the participants are in a state of complete or partial darkness for a certain period of time, which is easy to produce dark phobia. In clinical practice, investigators found that more than 80% of children with advanced ophthalmology were prone to leprosy, resistance, crying and other symptoms after general anesthesia, which brought greater difficulties to nursing. How to improve the cognitive ability of preschool children, reduce the anxiety level of children during the perioperative period, the incidence of postoperative detention and the difficulty of nursing are new topics worthy of exploration.

NCT ID: NCT04834427 Enrolling by invitation - Postoperative Pain Clinical Trials

Safety and Efficacy Evaluation of S (+) - Ketamine in Children

Start date: April 20, 2022
Phase: Phase 4
Study type: Interventional

A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in children in perioperative settings.

NCT ID: NCT04047485 Enrolling by invitation - Dementia Clinical Trials

Evaluation of the Effect of Cataract Surgery on Cognitive Function in Very Elderly Patients

Start date: February 2, 2019
Phase:
Study type: Observational

The study intends to measure the evolution over time of the cognitive capacity of patients undergoing cataract surgery in relation to the opaque lens removal surgery (cataract) in a population considered to be at risk of neurocognitive degeneration. Secondary objectives: • Estimate the incidence of postoperative cognitive dysfunctions and any episodes of perioperative delirium with the aim of demonstrating the safety of cataract surgery in the elderly patient in terms of cognitive functions and impact on the psychological state. In the context of the study a risk sub-population analysis will be carried out, evaluating the trend over time of the "endothelial cells count" parameter The elderly population remains, due to the aging of the cornea, a population "at risk" for significant alterations from the clinical point of view. During the study the endothelial cells count will be monitored, in order to be able to evaluate the safety of the cataract surgery and to be able to correctly correlate a possible deterioration in the visual acuity of patients with corneal decompensation. To evaluate the progress of the endothelial cells count in the elderly patient during the pre-intervention and post-intervention period. Since the low values of cellular media in endothelial microscopy are an element that increases the risk of complications during cataract surgery, the study wants to assess how waiting times between filter visits and cataract surgery can cause an elderly patient worsening of this parameter even in a few months. The trend of the same parameter will be monitored even after the intervention since in case of decrease, the low endothelial count could cause an alteration of visual acuity and therefore a minor improvement in cognitive performance. The research will be set as a longitudinal observational study where will be compared in each patient the parameters analyzed in the 6 months prior to cataract surgery and in the 3 months following the operation itself. Patients will be enrolled during the first cataract filter visit, will be submitted to simple questions and their clinical data will be collected. Subsequently, before and after three months of surgery repeated cognitive testing and the control normally performed instrumental tests during follow-up. A clinical follow-up will be provided, during normal follow-up visits at 20 days and 6 months after the patient's surgery: the following information will be collected during these visits - BCVA (visual acuity) - endothelial cells microscopy - OCT macula and optic nerve - Catquest 9SF; - Barthel Index; - Six Item Cognitive Test - Confusion Assessment Method (CAM): this exam will be performed within 24 hours of post-surgery and 20 days after surgery. It is important to underline that the cognitive tests proposed to patients consist of simple questions that do not depend on the visual ability of the subject.