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Psychomotor Agitation clinical trials

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NCT ID: NCT06451952 Not yet recruiting - Clinical trials for Agitation in Dementia, Including Alzheimer's Disease

Virtual Darkness Theraphy for Agitation in Dementia

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

Behavioral and psychological symptoms of dementia (BPSD) such as anxiety, depression, psychosis and agitation, are prevalent, often treatment resistant, resource demanding and significantly deteriorates cognition, independency, quality of life and mortality in people with dementia. The DARK.DEM trial aims at developing new diagnostics and treatment for BPSD in both specialized and municipal dementia care. The investigators will develop digital phenotyping by determining the convergent validity of data from a smartwatch against established psychometric scales for BPSD for patients admitted to NKS Olaviken gerontopsychiatric hospital. The investigators will conduct an open label single blinded randomized controlled trial to determine the effectiveness, feasibility and safety of virtual darkness as adjunctive treatment of agitation in patients with dementia admitted to the hospital. The investigators will randomize minimum 72 patients to treatment as usual (psychotropic drugs, psychological and environmental interventions) or 14 days of virtual darkness therapy, that is, exposure to light deprived of blue wavelengths from 19.00-08.00, provided in a secluded patient unit with circadian lightening. Primary outcome is 14 days change in agitation assessed with Cohen-Mansfield Agitation Inventory. Secondary outcomes are change in diurnal variation of motor activity assessed with a smartwatch, other BPSD, activities of daily living, quality of life, use of psychotropic drugs, use of restraints and coercion, length of hospital stay and resource utilization. The investigators will conduct focus group interviews with managers and staff in nursing homes to explore barriers, enablers and adaptions to support implementation of the new methods in municipal dementia care

NCT ID: NCT06387953 Not yet recruiting - Emergence Delirium Clinical Trials

Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy

Start date: May 2024
Phase: N/A
Study type: Interventional

This is a randomized, prospective, double-blinded (patient and outcome-assessor) trial. Our goal is to assess efficacy of Bridge Therapy (versus sham bridge therapy) to prevent emergence agitation following general anesthesia. Primary Objective: Activation of Bridge Therapy from the time of the pre incision "time out" until 24 hours after admission to the PACU (Post Anesthesia Care Unit) is associated with reduced frequency and intensity of emergence agitation. Secondary Objective: Bridge Therapy activation will also result in a lower incidence of rescue pharmacologic treatment of agitation. Tertiary Objective: Activation of Bridge Therapy during a stable anesthetic state is associated with a reduced Patient State Index as measured on Sedline

NCT ID: NCT06312618 Not yet recruiting - Emergence Agitation Clinical Trials

Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation

Start date: March 15, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is: • Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine? Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane.

NCT ID: NCT06218680 Not yet recruiting - Emergence Agitation Clinical Trials

Efficacy of Low Dose Propofol Given at the End of Sevoflurane Anesthesia for Prevention of Emergence Agitation in Pediatric Patient Undergoing MRI Scan

Start date: January 20, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare Efficacy of low dose propofol(0.5 mg/kg) vs placebo given at the end of sevoflurane anesthesia for prevention of emergence agitation in pediatric patient undergoing MRI scan. The main question it aims to answer is "Can low dose propofol reduce the incidence of emergence agitation after general anesthesia?" Participants will be given propofol 0.5 mg/kg or saline according to the allocated group at the completion of MRI scan

NCT ID: NCT06104436 Not yet recruiting - Dementia Clinical Trials

Individualized Music Playlist Based on ISO Principle for De-escalation of Agitation in Dementia

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

The goal of this clinical trial is to evaluate the efficacy of an Individualized Music Playlist (InMP) composed of preferred music genres sequenced according to the ISO-Principle, for the immediate de-escalation of agitation in dementia, compared with preferred music (PM) and treatment as usual (TAU).

NCT ID: NCT06079710 Not yet recruiting - Anesthesia Clinical Trials

Effect of Intraoperative and Awakening Electroencephalogram on Awakening Agitation After General Anesthesia in Children

Start date: November 1, 2023
Phase:
Study type: Observational

The purpose of this study was to analyze the relationship between intraoperative and awakening electroencephalogram waveforms and awakening agitation after general anesthesia in children

NCT ID: NCT06052254 Not yet recruiting - Agitation Clinical Trials

Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type

Start date: December 2023
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.

NCT ID: NCT05974527 Not yet recruiting - Schizophrenia Clinical Trials

Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department

Start date: September 1, 2023
Phase: Phase 4
Study type: Interventional

This is a single-arm pilot study to examine the impact of BXCL501 (sublingual film formulation of dexmedetomidine) administration on reducing the severity of undifferentiated acute agitation in patients presenting to the emergency department with underlying bipolar disorder or schizophrenia. This study is designed to evaluate BXCL501 for its FDA-approved indication -- treatment of agitation associated with bipolar disorder or schizophrenia -- applied in the emergency department setting.

NCT ID: NCT05803642 Not yet recruiting - Acute Agitation Clinical Trials

A Study of Olanzapine in Patients With Acute Agitation

Start date: March 28, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania.

NCT ID: NCT05774145 Not yet recruiting - COPD Clinical Trials

Dexmeditomedine Versus No Sedation in Management of Agitation in COPD Patients Receiving Noninvasive Ventilation

Start date: March 2023
Phase:
Study type: Observational

The aim is to compare sedation using dexmedetomidine to sedation -free approach in management of agitated COPD patients receiving NIV