ANZCTR search results

Schizophrenia impacts 7 per 1000 people globally, and half have developed metabolic syndrome, representing significant cardiometabolic burden leading to excess early mortality. Moreover, schizophrenia commonly starts early in life (late adolescence and 20s), is chronic and requires long term pharmacotherapy which is often obesigenic. This means that individuals may begin to suffer from sleep apnoea much earlier than the general population and have a much longer life-time hypoxic burden. This 4-site 140 patient non-inferiority trial will inform health funders, clinicians, patients and their carers as to the 12-month clinical and cost benefits of funding simpler at home tests (i.e. 3 nights of at-home overnight oximetry instead of full in-laboratory polysomnography) for sleep apnoea in this special and severely undertreated population to speed access to treatment. Key clinical outcomes are Quality of Life (AQoL-8D - which also helps to inform the cost effectiveness), sleepiness, HbA1c, affect and cognition. Our highly skilled clinical and clinical trials research team will enable widespread and rapid translation of trial outcomes into clinical practice, creating a unique opportunity to gather evidence to generate significant health improvements for this high metabolic-risk population that is notably under-served. The main objective of this study is to evaluate whether 3-night home oximetry is clinically non-inferior (in terms of quality of life) and more cost effective, to the standard in-laboratory method.

Despite strong evidence demonstrating the ubiquity of mobile phones in hospitals, and their potential to act as fomites for pathogens and healthcare associated infections, there remains a paucity of evidence specifically reporting their use in the high-risk area of the intensive care unit. Furthermore, previous studies of mobile phone use in healthcare settings have been survey-based and have not specifically reported violations of infection control procedures. Therefore, this study aimed to observe the real-time mobile phone use and behaviours of patients, visitors, and healthcare workers in ICU. Additionally, the study investigated the impact of mobile phone use on the five moments of hand hygiene, with results expected to inform future studies of potential mobile phone sanitisation solutions.

Preterm infants, particularly those born before 31 weeks, are at risk of incurable blindness from a condition called retinopathy of prematurity (ROP). Regular screening eye examinations in the neonatal intensive care units (NICU) monitor for ROP disease. Unfortunately, these eye examinations are painful and stressful, and research has shown that untreated stress in preterm infants leads to adverse neurodevelopment and even mental health problems. Currently there is no effective and safe way of reducing distress from eye examinations. In this study, we propose using a medication, dexmedetomidine for pain relief for the ROP eye checks. Dexmedetomidine is used increasingly for sick babies in NICUs, usually intravenously (which is painful and distressing in itself). We plan to give dexmedetomidine intranasally(via a special nasal spray device) as well as the usual standard comfort measures and compare pain scores and other physiological parameters such as oxygen levels, heart rates and breathing rates from this group of babies to those who will receive usual comfort strategies used during standard ROP eye examinations. We hypothesise that intranasal dexmedetomidine would reduce infant discomfort and improve infant physiological parameters including oxygenation.

Australian families of patients with severe neurological impairments (SNIs) lack mental health support despite high rates of depression, anxiety and stress. Parents and siblings report poor mental health, including anxiety and depression symptoms, and difficulties communicating with each other about the patient’s condition. This project will pilot an online intervention designed to improve sibling mental health and communication between siblings and parents called SIBS-ONLINE. SIBS-ONLINE was developed in Norway in 2023 and this will be the first study to test it with an Australian sample. The online program runs for six weeks – so siblings and parents will attend one session per week, six times.

The aim of the study is to prove that there is no greater risk of infection or inflammation to the patient when the patient, who has successfully completed the competency, self exchanges an antibiotic infuser compared with a nurse completing the same procedure. When this hypothesis has been proven then the local health district will be looking at amending procedure in community to accommodate community patients to avoid presenting to emergency departments or delay discharge from hospital due to antibiotic intravenous treatment.

The current project is a single-arm pilot trial which aims to evaluate user engagement, feasibility, and acceptability of a tailored digital CBM-I intervention for adolescents who have elevated symptoms of generalised anxiety, social anxiety, and/or panic disorder, above a clinical threshold. An improved CBM-I program has been developed in consultation with adolescents and mental health professionals to maximise engagement and relevance of content and features for adolescents with anxiety. Adolescents aged 14-17 years who are reported to experience anxiety symptoms above a clinical cut-off on a self-report diagnostic measure are eligible to participate. User engagement will be assessed by objective usage data (i.e., number of sessions completed, participant dropout, time spent using program) as well as a questionnaire and semi-structured exit interview immediately post-intervention or at time of dropout. Changes in anxiety (and, secondarily, depressive symptoms) and life interference, and interpretation bias will be assessed before and after the intervention period.

A total of 16 autistic children (3-8 years of age) who are nonverbal or minimally speaking will be recruited to participate in this project to evaluate Language Acquisition through Motor Planning (LAMP). LAMP is an AAC based therapeutic approach based on neurological and motor learning principles. A non-concurrent multiple baseline design with randomised baselines will be used to examine the effectiveness of LAMP delivered (1hr/week for 20 weeks) in a clinical setting. This research project has three key aims: 1. To evaluate the acceptability, feasibility, and effectiveness of LAMP for autistic children with minimal verbal language, delivered in a clinical setting. 2. To explore child, family, and service characteristics associated with individual outcomes. 3. To examine the clinician maintenance of fidelity to the LAMP therapy approach after completing the LAMP training workshop and certification program.

Eosinophilic oesophagitis (EoE) is a chronic inflammatory condition causing narrowing of the oesophagus, manifesting clinically as dysphagia and food bolus impaction (FBO).Proton pump inhibitors (PPI’s) are a mainstay in treatment of EoE, and have proven efficacy in inducing and maintaining remission according to systematic reviews and meta-analysis. Optimal total daily dose and dose frequency schedule of PPI is an under-researched area of immediate relevance to patient care and implications include convenience, cost and safety. In the context of a current knowledge gap for optimal dosing of pantoprazole for patients with EoE who have responded to routine dosing at 40mg orally twice daily, we propose a RCT of dose adjustment to 40mg tablet orally once daily compared to 20mg tablet orally once daily, with a formalised treatment protocol and the ascertainment of symptom scores (questionnaire), endoscopic appearance, and histological findings (biopsy). The results will have the potential to improve management in future.

Eosinophilic oesophagitis (EoE) is a common cause of dysphagia and is now the leading cause of food bolus impaction (FBO) in Western countries. The most effective treatment for EoE is budesonide orodispersible tablet (BOT - Jorveza™). A new topical corticosteroid called Jorveza became available in May of 2022 and demonstrated efficacy with complete resolution of EoE at 1mg orally twice daily in 80% of recipients. Many patients and clinicians attempt dose reduction to 1mg orally once daily with the hope of improving convenience, compliance and reducing side effects, yet there is no evidence that reducing total dose or reducing dose frequency will maintain remission. A randomised trial of Budesonide Orodispersible tablet (BOT) at 2mg orally once daily compared to 1mg orally once daily in patients with EoE who initially respond to 1mg orally twice daily is thus proposed.

This study aims to investigate the effects of low-level laser therapy (LLLT) during orthodontic tooth intrusion. Specifically, it will assess whether LLLT can reduce tooth root resorption, preserve pulp chamber volume, and decrease patient-reported pain compared to a sham (inactive) laser. Maxillary first premolar teeth will be intruded over an 8-week period, and changes in root and pulp volumes will be quantitatively measured using micro-CT imaging.