ANZCTR search results

This research aims to trial the intervention My Vital Cycles to improve ovulatory menstrual health literacy, mental wellbeing and selected menstrual health challenges among 13–19-year-old adolescent girls. Teachers and school healthcare professionals from 10-12 schools will be trained to deliver the intervention, which will be trialed with a convenience sample of 420 female adolescents. Expected health outcomes include improvements in mental wellbeing and management of cycle dysfunctions including iron and Vitamin D deficiencies.

Since implementation in 2023, the QNRG+ (COSMED, Italy) indirect calorimetry (IC) device has been used regularly in the paediatric critical care unit (PCC) at Perth Children’s Hospital (PCH) as standard of care to guide nutritional targets on invasively mechanically ventilated (IMV) patients. However, feasibility of this device is yet to be described in paediatrics. This observational cohort study aims to 1) describe the implementation and feasibility of IC in PCC to inform practice / resources for other centres nationally and internationally, 2) determine if correlation exists between measured energy requirements and common PCC factors, such as level of sedation, and 3) determine if correlation exists between proportion of IC-guided energy targets delivered and changes in body composition. To describe IC feasibility, we will screen all invasively mechanically ventilated patients daily for an 18-month data collection period, aiming to recruit and screen a minimum of 250 patients, to assess proportion of patients and PCC days where both technical and stability criteria are met, to be able to perform IC. IC tests will be performed on all eligible participants, with proportion of successful vs unsuccessful rests reported. To describe measured energy expenditure (MEE) variability in invasively mechanically ventilated paediatric patients, we will document factors, such as level of sedation, temperature and nutrition, provided during each IC test. Updates to COSMED firmware in 2026 will allow opportunity for IC testing in children who weigh <10kg, and both feasibility and MEE data in this population will be crucial. To describe changes in body composition, skeletal muscle ultrasound and bio-impedance devices will be utilised, as per current PCC standard of care, and daily nutrition data will be collected. Recruitment will continue for a total of 36-months or more to ensure adequate participant numbers, and to capture data on infants and children who are <10kg.

AURA is a single-centre, outcome-blind pilot randomised controlled trial (RCT) designed to evaluate the effectiveness of autofluorescence-guided antimicrobial dressings in managing diabetic foot ulcers (DFUs). Conducted at Fiona Stanley Hospital (FSH), the trial will recruit adult patients from podiatry outpatient and Multidisciplinary Diabetic Foot Ulcer (MDFU) clinics. Eligible participants will be those with a DFU with <50% reduction in area in 4 weeks (“hard to heal ulcers”). Baseline data will be collected in accordance with international standards for DFU management. All participants will have their wounds cleansed and imaged using the MolecuLight i:X device to detect autofluorescence (AF), which indicates bacterial presence. Participants with negative AF (AF-) will receive standard care, including offloading, infection management, glucose control, and sharp debridement, along with inert dressings selected for exudate control, comfort, and cost. Participants with positive AF (AF+) will be randomised into two groups: one receiving antimicrobial dressings (AF+AD) and the other receiving inert dressings (AF+C), both alongside standard care. Dressing changes between clinic visits will be managed by carers or community nurses. All participants will attend follow-up appointments every two weeks over a 12-week period for ongoing podiatric treatment and wound evaluation. The study aims to recruit 60 AF+ patients, with 30 allocated to each treatment arm. The trial’s goal is to assess whether autofluorescence-guided antimicrobial dressing use improves DFU outcomes compared to inert dressings, potentially informing future clinical practice and larger-scale studies.

This study aims to test a new automated device that delivers antibiotics gradually before surgery. The device, called IRIS, gives multiple smaller doses over 30 minutes, rather than one large dose, to reduce the risk of severe allergic reactions. We hypothesize that IRIS will both lower the chance of serious allergic events and still ensure patients receive enough antibiotic protection before surgery starts. By checking how easy IRIS is to use and whether it can safely administer the entire dose on time, we hope to show it can improve patient safety. If successful, this approach could make pre-operative antibiotic administration safer and more reliable in the future.

Pholcodine is an over-the-counter cough medicine that may increase the risk of severe allergic reactions to neuromuscular blocking agents (NMBAs) used during anaesthesia. In March 2023, all pholcodine-containing cough products were withdrawn from the Australian market. This study will use a prospectively approved and maintained Western Australian perioperative allergy registry to examine whether the withdrawal was followed by changes in the number of clinically investigated allergic reactions attributed to NMBAs, compared with reactions attributed to other drugs. Monthly counts of reactions from January 2016 to November 2025 will be analysed using interrupted time-series regression, focusing on level and trend changes at the time of the pholcodine withdrawal. No additional procedures, tests or changes to anaesthetic care are introduced as part of this study; it is a statistical analysis of existing clinical registry data.

The purpose of this research study is to assess the safety and practicality of using wearable devices to monitor vital signs, such as heart rate, temperature and blood pressure, in patients receiving chemotherapy and/or immunotherapy for relapsed/refractory myeloma. Who is it for? you may be eligible for this study if you are an adult who has been diagnosed with relapsed/refractory myeloma. Study details Participants will wear remote monitoring devices for 30 days following the administration of chemo-immunotherapy or CAR-T cell therapy. Vital signs will be checked 4 times a day for 30 days, participants will complete some quality-of-life questionnaires at the end of the monitoring phase and follow-up data will be collected for 100 days. This study is to inform current clinical practice incorporating wearable device technology with a goal to assist patients into the earliest, and safest, timeframe for community-based care while receiving chemo-immunotherapy and cellular therapies.

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.

Co-morbid insomnia and obstructive sleep apnea (COMISA) is common. When these disorders co-occur, they result in additive impairments to patients’ sleep, daytime functioning, and quality of life. Compared to OSA-only patients, patients with COMISA are likely to have mild upper airway collapsibility and a low respiratory arousal threshold. Targeting these two physiological traits serves as the scientific rationale for this investigation. Interestingly, trazodone is the only hypnotic that has been shown to significantly increase the arousal threshold in patients with obstructive sleep apnea (OSA). Trazodone is also effective in treating insomnia. Sulthiame has been shown to target airway collapsibility and high loop gain. As such, the combination of these two agents is postulated as a synergistic approach to the treatment of OSA and insomnia in patients with COMISA. Study Aims: The primary goal of the current study is to determine the effect of the combination of sulthiame and trazodone on OSA and insomnia severity in patients with COMISA. Specifically, we will assess the effect of combination pharmacological therapy on OSA severity as measured by the apnea-hypopnea index [AHI 3a% criteria, primary outcome] and insomnia as measured by the insomnia severity index [ISI, secondary outcome]. Hypothesis: We will test the primary hypothesis that combining therapies to lower loop gain (sulthiame) and increase the arousal threshold (trazodone) will improve OSA severity (AHI3a) and insomnia severity (ISI) compared to placebo in patients with COMISA.

To create scalable solutions for the growing number of people living with dementia, we developed MATCH. MATCH is an eHealth solution – Music Attuned Technology for Care via eHealth – developed to support care staff to use music intentionally to support care with people with dementia. The MATCH App has been developed for home and professional care (RAC/hospital) settings, and preliminary trials have been conducted in Victoria, South Australia, and Western Australia. MATCHplus integrates the MATCH App with a bespoke agitation detection system via wearable sensors and an AI-based music recommender system. In this study we will recruit across different professional care settings to: a) Assess the feasibility of implementing MATCH in dementia care in different professional aged care settings; b) Understand the impact of using MATCH Strategies during care on their job satisfaction and care outcomes using self-reported data from care staff; c) Collect data via clinical assessment tools to understand the impact of using MATCH Strategies during personal care and in moments of agitation on neuropsychiatric symptoms of dementia; d) Explore the feasibility, acceptability and utility of the MATCH agitation detection and prediction system; e) Explore the feasibility, acceptability and utility of the MATCH music recommender system for suggesting appropriate individualised music; f) Understand care staff experiences of using MATCH Strategies during care using post-trial interviews; and g) Understand nursing (registered nurse/nurse-in-charge) and management perspectives on the acceptability and utility of implementing MATCH in their professional care setting using post-trial interviews.

This study is being conducted to find out if the ROMI device can help patients with dizziness to be sent to the right specialist (e.g. vestibular physiotherapist, neurologist) first time rather than a long wait to be assessed by an ENT. This study employs a randomised, controlled trial design to assess both the predictive value and clinical utility of the ROMI test as a triage of those with episodic dizziness. The ROMI is a portable device that allows patients to capture their eye movements during dizziness attacks. Patients referred with undiagnosed vertigo will be prospectively randomised into either a control group which will undergo standard care or into the interventional group which will use the portable diagnostic device and also the standard care pathways. Participants that undertake the ROMI test will do so while on the ENT waitlist and will see the ENT specialist on the date of their allotted appointment with the results of the ROMI test (assessed by an Audiologist) provided to the ENT specialist .