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Agitation clinical trials

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NCT ID: NCT06140342 Recruiting - Dementia Clinical Trials

A Music-Based Mobile App for People Living With Alzheimer's Disease and Related Dementias (ADRD)

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

The purpose of this pilot is to develop a mobile application that detects physiological measures of individuals with Alzheimer's disease and related dementias and triggers auto-play of personalized songs in a wearable device. The investigators will test the feasibility and acceptability of the app. This app may be an important tool to include in daily caregiving in a home setting by extending established benefits of music therapy for people with Alzheimer's disease and related dementias.

NCT ID: NCT06037629 Recruiting - Acute Pain Clinical Trials

Premature Enhanced Automated Capture of Comfort Knowledge

PEACOCK
Start date: February 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals.

NCT ID: NCT05644262 Recruiting - Dementia Clinical Trials

Life's End Benefits of Cannabidiol and Tetrahydrocannabinol

LiBBY
Start date: December 18, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 150 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 24 week optional open-label extension will be offered to participants who complete the double-period.

NCT ID: NCT05557409 Recruiting - Alzheimer Disease Clinical Trials

A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation

ADVANCE-2
Start date: September 6, 2022
Phase: Phase 3
Study type: Interventional

This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.

NCT ID: NCT05397639 Recruiting - Agitation Clinical Trials

Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type

Start date: November 1, 2022
Phase: Phase 3
Study type: Interventional

This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

NCT ID: NCT05273671 Recruiting - Agitation Clinical Trials

Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics

Start date: March 1, 2022
Phase: Phase 4
Study type: Interventional

the investigators hypothesized that Nalbuphine may be alternative pharmacological agent for prevention of emergence agitation in pediatrics who will be scheduled for elective lower abdominal surgical procedures (inguinal hernia repair and hypospadias) during sevoflurane anesthesia

NCT ID: NCT04516057 Recruiting - Alzheimer Disease Clinical Trials

Nabilone for Agitation Blinded Intervention Trial

NAB-IT
Start date: February 1, 2021
Phase: Phase 3
Study type: Interventional

This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms. Agitation is associated with faster progression to institutionalization, increased caregiver burden, poorer quality of life, and increased risk of death. In addition, current pharmacological options show only modest efficacy and elevated risks of adverse events. Therefore, identifying safer and more effective treatments for agitation in AD is a clinical and research priority. Nabilone is a synthetic cannabinoid that is Health Canada-approved to treat chemotherapy-induced nausea and vomiting. The PI's research group completed a 6-week double-blind placebo-controlled randomized cross-over pilot trial in 38 patients with moderate-to-severe AD, providing the first preliminary evidence regarding the safety and efficacy of nabilone in this population. They found that nabilone significantly improved agitation, overall neuropsychiatric symptoms, and caregiver distress. That study was limited by its sample size and questions remain regarding the efficacy of nabilone for nutrition and pain and predictors of response. However, the promising preliminary findings encourage a pivotal, practice-changing phase III trial to inform clinical practice. Participants in this study will be randomized to receive either nabilone or a placebo for 8 weeks. In addition to looking at the effectiveness of nabilone in treating agitation, the researchers will also look at whether it is beneficial for other relevant outcomes for patients with AD including overall neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, and pain. Participants will also be followed for 8 weeks following completion of the study treatment.

NCT ID: NCT04312893 Recruiting - Delirium Clinical Trials

The Effectiveness of Acupuncture for Delirium in Critically Ill Patients

Start date: March 12, 2020
Phase: N/A
Study type: Interventional

Introduction: Intensive care unit (ICU) delirium is an acute onset of brain dysfunction, which can affect 25-80% of ICU patients. Delirium is also associated with long term cognition impairment, higher mortality and higher ICU costs. Previous acupuncture studies showed the potential to prevent delirium. This study will examine the ability of acupuncture to treat ICU delirium. Methods: A double-blind randomized control trial will examine the effect of press tack acupuncture vs. press tack placebos. The patients will be randomly divided (1:1) into one of two groups. A total of 80 ICU patient will have to meet the following criteria: age 20-90, APACHE score <30, Intensive Care Delirium Screening Checklist (ICDSC) >4 points (indicates existing delirium), Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4, -1, -2. Three interventions will be given in each group. The main outcomes will be the delirium days according to the ICDSC.

NCT ID: NCT04039269 Recruiting - Behavior Clinical Trials

Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change

Start date: December 2013
Phase: N/A
Study type: Interventional

The study is designed to test the hypothesis that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.

NCT ID: NCT03398759 Recruiting - Agitation Clinical Trials

Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Emergence agitation is one of the common postoperative complications after functional endoscopic sinus surgery(FESS). The objective of present study is to explore the effectiveness of butorphanol in the alleviation of emergence agitation in patients undergoing Functional Endoscopic Sinus Surgery.