ANZCTR search results

The eustachian tube constitutes a natural conduit between the middle ear (ME) and the nasopharynx and is essential for normal ME function. Eustachian tube dilatory dysfunction (ETDD) causes inadequate ventilation of the ME and is associated with significant morbidity. Several treatments have been proposed to treat ETDD, including breathing manoeuvres, pharmacological agents, mechanical devices and nasal surgery, though these methods have had limited success and can be ineffective at treating the underlying tubal dysfunction. Recently, catheter assisted balloon dilatation of the eustachian tube (BDET) has been undertaken as a means of improving ME ventilation and eustachian tube compliance with safety and success for the treatment of persistent ETDD. The proposed study aims to assess the effectiveness of the Spiggle and Theis Medizentechnik balloon catheter system for the treatment of ETDD in conjunction with medical management (MM) of ETDD compared with MM alone. Participants with a diagnosis of ETTD who consent, will be randomised to BDET + MM or MM alone and followed up at 2,6,12 and 24 weeks. They will undergo repeat examination and tympanometry to examine for resolution of ETDD. The primary outcome measure for the study will be normalisation of tympanometry at 6 weeks post intervention. For patients in the control group that elect to do so, they will be permitted to undergo the intervention intervention. The proposed study is a prospective multicenter, non­-significant risk, randomised control trial that has been designed to demonstrate the superiority of balloon dilatation of the eustachian tube using a eustachian tube balloon catheter plus medical management when compared to medical management alone for the treatment of ETDD.

Cardiovascular disease remains a leading cause of morbidity and mortality in the developed world. Patients who have heart attacks remain the highest risk group, with up to 30% dying or having a further event in 3 years and improved methods of risk stratification are urgently needed. Intra-coronary optical coherence tomography (OCT) is a modality based on near infrared spectrum light with a superior resolution of the high risk components of coronary plaque. We hypothesise that coronary OCT imaging at the time of routine coronary revascularisation when combined with computational methods will be superior to conventional risk scores in predicting future major adverse cardiovascular events. Patients admitted with a Non ST elevation Myocardial Infarction (NSTEMI) and who proceed to inpatient angiography or a ST Elevation Myocardial Infarction (STEMI) and who proceed to non-emergency in-patient angiography or stable/unstable angina may be eligible to participate in the study. The study aims to 1) to determine the predictive value of high risk plaque on OCT for patient oriented clinical events (POCE: recurrent myocardial infarction, coronary revascularisation or death). 2) to determine the predictive value of OCT derived low endothelial shear stress for recurrent POCE. 3) To determine the predictive value of OCT derived high endothelial shear stress for recurrent myocardial infarction and death 4) To develop a multivariate model for predicting residual risk based on multiple imaging parameters and determine its incremental predictive power when added to clinical risk factors and existing risk scores (eg. GRACE-score, Syntax score, Clinical Syntax score).

Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial or ‘TRIDENT’, is investigating the effectiveness of more intensive blood pressure-lowering treatment to prevent recurrent stroke. As part of the TRIDENT study, we are inviting participants to the TRIDENT Cognitive Sub-study to assess the effectiveness of the TRIDENT blood pressure-lowering study treatment on cognition as assessed by neuropsychological tests. ‘Cognition’ is a term referring to memory and other thinking skills. These processes include speed of thinking, finding words, visual skills and problem-solving. Neuropsychological tests, also referred to as ‘cognitive assessments’ assess these mental processes. Cerebral small vessel disease (CSVD) is a disease process in the brain involving small blood vessels. CSVD is common in people who have had a stroke caused by intracerebral haemorrhage (ICH) (large bleed in the brain). CSVD has been shown to be associated with dementia, memory problems, balance disturbances and other neurological conditions such as Parkinson’s disease. CSVD is also known to be more common in people with high blood pressure or hypertension. There is uncertainty, however, if lowering blood pressure slows the progression of cognitive decline associated with CSVD. The purpose of this study is to investigate the effect of intensive blood pressure-lowering treatment on cognitive decline measured by specific neuropsychological tests.

The Synergy Online System collects data via multiple sources including online self-report, health professional and service surveys as well as third-party integrations (e.g. Fitbit) as a means to offer individual user’s personalised assessment and intervention options as well as continuous monitoring. This research employs a naturalistic prospective clinical trial design wherein all individuals presenting for care to a traditional face-to-face or online mental health service (participating in Project Synergy research studies) will be informed of the trial via a tiered consenting process including 'opt-out'. Upon consent, Synergy collects, stores and analyses personal and health information (data) in its database. By taking part in this clinical trial, participants give researchers permission to access their non-identified data, which will be used to scientifically, clinically and analytically validate "stage-based stepped-care" recommendations generated by the System.

Septic shock is a state of low blood pressure resulting from a physiological response to an infection. The low blood pressure commonly presents along with an elevated heart rate, which is in turn associated with poor outcomes in patients. Beta blockers have had favourable effects in the past, but its use in this clinical context may potentially lead to an exacerbation of the low blood pressure. Ivabradine causes selective heart rate reduction via an alternative pathway and is not known to have any other effects on the heart. It has previously been shown to have benefit in the treatment of chronic heart failure and stable cardiac disease, and previous studies have documented safety and tolerability. Furthermore, it has been used in acute medicine for the treat-ment of patients with low blood pressure due to acute heart failure and is currently being tested in critically ill patients with multi-organ failure. We propose to conduct a feasibility study to test whether Ivabradine can be used safely to reduce the heart rate in patients who are in septic shock with an elevated heart rate.

PTSD is the most common psychological disorder in veterans, and while evidence-based treatments exist, much can be done to improve outcomes. The study is a pilot randomised-controlled-trial comparing two interventions in veterans with a diagnosis of PTSD before and after they receive standard hospital treatment. This study will test the efficacy of two types of attention training to augment standard treatment for veterans with a diagnosis of PTSD. Attention training is delivered via computer and involves participants viewing words on a screen and then pressing a corresponding button on the keyboard. The first task, ‘Attention Control Training’ (ACT) works by re-balancing attention, whilst 'Attention Bias Modification; (ABM) aims to decrease over-responding to threat stimuli. We want to investigate whether receiving either one of these attention training programs significantly improves mental health outcomes after receiving standard treatment.

Traditionally, latent tuberculosis infection (LTBI) in Australia are treated with either six to nine months of daily isoniazid (6-9H). These regimens are hepatotoxic and long. Recent randomized trials have shown that two shorter regimens are equally effective, but substantially less toxic. Four months of daily rifampicin (4RIF) and three months of once weekly rifapentine and isoniazid (3HP). This study will address the following primary research question: What is the treatment completion rate for patients with LTBI treated with home-based 3HP plus SMS monitoring, compared to daily self-administered 4RIF?

The purpose of this study is to examine the feasibility of body-mind exercises (called ‘Qigong’) for cancer survivors. Who is it for? You may be eligible for this study if you are aged 18 or over, completed anticancer treatment at least 3 months ago and meet a criteria for insomnia. Study details All participants will partake in a three week group program, involving two face-to-face sessions and three online sessions. The program will involve slow-moving gentle exercise in a standing or sitting position. Participants will complete a diary and answer some questionnaires throughout the three week program and for a week after the program It is hoped this research will provide some evidence of the feasibility and potential benefits of Qigong for insomnia in this patient group.

Cardiac rehabilitation (CR) is an important secondary prevention strategy, yet women’s participation is low. It has been postulated that lower self-efficacy and social and psychological factors contribute to a low participation (Briffa et al 2009). Literature suggests that CR programs specifically designed for women, based on their expressed needs, are effective in improving the physical functioning and symptom status of participants. The aim of this project is to investigate the use of a gendered approach to healthcare through developing strategies to improve women’s heart health in Australia, including evaluating in a randomised controlled trial the benefit of a group-based program, tailored specifically to the needs of women, to increased self-efficacy and improve functional status. Key components of the intervention include information about heart disease, changing social roles, the impact of emotions on cardiovascular health, coping with stress, communication, and strategies to promote self-management. This project incorporates a gendered approach to health care, which is commonly lacking in cardiovascular science.

Insomnia is a highly prevalent chronic illness with approximately 30% of Australian adults classified as having insomnia or insomnia symptoms. The societal costs are significant with an estimated $10.9 billion in direct and indirect costs in Australia. Insomnia patients have poor health related quality-of-life, increased risk of depression, increased workplace disability and costs, impaired driving performance and increased risk of death from motor and unintentional fatal injuries. The majority of people with insomnia who are treated by primary care physicians will be prescribed hypnotic medications. This is despite substantial evidence that hypnotics are only marginally more effective than placebo and are not effective for long-term management. Hypnotics also come with significant risk for a range of side-effects (falls, car crashes, accidents and potentially increased overall mortality). Cognitive Behaviour Therapy for Insomnia (CBTi) has shown to be more effective long-term solution for people with insomnia. However, CBTi has major drawbacks as it requires specifically trained therapists, and is a complex time-consuming composite therapy that may include therapeutically redundant components. Sleep Consolidation Therapy is a behavioural component of CBTi that has been specifically tested in isolation and found to be as effective as multi-component interventions. The therapy ‘consolidates’ sleep-wake schedules by maximising sleep time through restricting bed time. This is achieved by anchoring bed times so that individuals are mildly sleep restricted which promotes sleep onset and decreases wake time in bed. The clinical delivery of the therapy can be relatively short (typically 1 hour delivery + weekly 10 minute telephone calls), but requires clinician input regularly. Sleep Consolidation Therapy has the potential to be delivered more widely as it has been shown to be feasible in primary care settings. We have recently developed a proof-of-concept mobile application following participatory design, user experience focus groups and a pilot study testing the engagement of the application. The mobile application can deliver population-based therapy for insomnia patients thereby improving scalability and treatment options. We now want to test the effectiveness of the mobile application to deliver Sleep Consolidation Therapy in participants with insomnia symptoms.