ANZCTR search results

Recent studies show that the incidence and severity of obstructive sleep apnoea (OSA) are influenced by the gain or sensitivity of the negative feedback loop controlling breathing (i.e. the loop gain), and that this influence is independent of the contributions made by anatomical and neuromuscular factors such as abnormalities of the soft palate or dysfunction of the oropharyngeal musculature. Accordingly, it follows that if we were to administer a drug that lowers an individuals loop gain, we would reduce the propensity for OSA and thereby ameliorate some, if not all, of the symptoms of sleep disordered breathing. We have evidence that administration of an orally-available drug, LGT-371, does indeed reduce the sensitivity of the peripheral and/or central chemoreceptors (and thereby overall loop gain) in an animal model of sleep disordered breathing and that it reduces the severity of sleep apnoea in the model. We now plan to test whether LGT-371 has a similar action in human subjects with OSA. The primary aim of this study is to assess the effect that LGT-371 has on sleep apnoea severity, loop gain and chemoreceptor sensitivity compared to placebo. Additional measures of sleep apnoea severity, cardiovascular markers (blood pressure & heart rate) and subjective sleepiness will also be assessed as secondary outcomes.

In the course of military training, personnel are trained to attend to cues in their environment that may signal threat, and in deployment situations this training can be life-saving. Upon return to civilian life however, constantly feeling alert and attending to cues that seem threatening can become a problem and in some cases this has been shown to be associated with the development of posttraumatic stress disorder (PTSD). PTSD is a common and often severe problem for many who serve in the military. In particular, it can involve constantly being on the lookout for danger, which may be compounded by training received during military training to be vigilant. Attention control training (ACT) is an intervention designed to modify the fluctuations in attention to threat that underpins PTSD. ACT is brief, computerised program that is delivered once weekly for four weeks. The trial will involve 1806 current serving personnel between 18 to 70 years of age who are transitioning out of the military within the next 12 weeks. Participation involves a number of short self-report assessments and attending weekly ACT or control training sessions over four consecutive weeks. All self-report assessments will be completed online using a mobile phone, and will be done four times in total: immediately before the intervention, immediately post-intervention (4 weeks), and at 3 and 12-months follow-up. The results of this trial will inform the broader military community both in Australia and overseas by improving our understanding of effective preventions for the development of mental health symptoms after military service.

Fibrosis, or hardening of tissues is a common side effect following cancer treatment, particularly radiotherapy. Evidence exists that combined treatment using Pentoxifylline (PTX) and Vitamin E (Vit E) reduces and even reverses fibrosis in breast cancer. This treatment is used at times in head and neck cancer but is not considered ‘routine’ treatment. The purpose of this study is to see whether this treatment can prevent relapse of hardened tissues in those with narrowing (called stricture) of the throat following head and neck cancer treatment. Who is it for? You may be eligible for this study if you are an adult who has completed treatment for head and neck cancer. Study details Participants will be randomly allocated to one of two groups: Group 1: 12 weeks of medication (pentoxifylline and vitamin E). Group 2: 12 weeks of placebo treatment. All participants will then be assessed one year later by endoscopy to measure the hardness of tissue in their throat. It is hoped that this study will demonstrate that this treatment is effective in reducing relapse of fibrosis in patients who have been treated with head and neck cancer.

Data from the 2015 Australian Government Early Developmental Index Census (AEDI; 2015) suggests that around 22% of Australian children are “developmentally vulnerable” on one or more domains at the start of school, with rates as high as 33% in disadvantaged communities. Recent advances in early childhood and brain development science highlight the importance of early identification and intervention for children at developmental risk to maximize child and family function and participation outcomes. Such opportunities are unfortunately missed in a substantial majority due to poor uptake of current surveillance programs that are voluntary with no mechanism for follow up. There is also evidence for an ‘inverse care law’, with those at highest risk (e.g., mothers born overseas, lower educational and income levels) being least likely to access developmental surveillance programs (Eapen et al., 2014). While GPs are usually the first point of contact for families, time pressures and lack of knowledge and confidence about assessments and referral pathways/support systems limit opportunities for early identification/intervention during these most critical years. We believe that by utilizing an interactive web-based tool at general appointments for children and during 18-month vaccination visit contacts at GP practices/Child and Family Health Nurse (CFHN) clinics, the uptake and coverage of current developmental surveillance programs will be significantly enhanced. This project will test the diagnostic accuracy of a web application developmental surveillance tool comprising (1) the ‘Watch Me Grow’ app (WMG app), a web-based application for parents, and (2) a GP/Health professional component that includes an algorithm with recommendations for next steps regarding review/assessments/investigations and/or referral pathways to early intervention. The project will take place over 3 phases: Phase 1. Recruitment and 18-month screening: Children (n=240) aged 18 months attending GP practices and CFHN clinics will be recruited for this study. At the clinic-based 18-month immunisation/personal health record (PHR) appointment, the parent will complete the WMG app assessment and the GP/CFHN/Practice Nurse will receive a summary of the screening results, referral considerations and parenting options through a secure messaging system (using the child’s name and date of birth) to inform their management plan. Phase 2. Comprehensive developmental assessment: All children identified at 18-months through the WMG app as being at developmental risk together with 10% of those who screen negative (to cover for any false negative results), will complete a comprehensive gold-standard developmental assessment protocol at 2 years of age. Phase 3. Comparison of numbers of children referred for more detailed developmental assessment during the study period with current “usual practice” at the participating sites..

This study is examining the efficacy and safety of a ChemoRadiation and ImmunOtherapy protocol called CIRO in unresectable skin squamous cell carcinoma. Who is it for? You may be eligible for this study if you are aged 18 or older and have an advance biopsy proven skin squamous cell carcinoma which can not be removed by surgery Study details All participants will receive the standard treatment (chemoradiation) for 7 weeks in conjunction with an immunotherapy medication called Durvalumab. CRIO stands for ChemoRadiation and ImmunOtherapy which involves the combination of radiotherapy, chemotherapy, and immunotherapy. Patients with advance skin squamous cell carcinoma which can not be removed by surgery represent a clinical challenge. These patients are often treated by radiotherapy and chemotherapy. Such approach is 50% successful in making the skin cancer disappear completely. We are hoping to improve the 50% figure to 70% by adding an immunotherapy called durvalumab.

Childhood obesity is a serious public health challenge. About one in five Australian children aged 2 to 3 years is now either overweight or obese. Early intervention is important as excess weight and fast weight gain in early childhood are related to being overweight later in life with considerable impact upon health and health services. Over the past 8 years we have developed, implemented and evaluated an early obesity intervention program funded by NHMRC. The project titled Healthy Beginnings Trial (HBT) was designed to improve infant feeding practices, eating habits, active play, and reduce TV viewing time to prevent childhood obesity in the first two years of life through staged home visiting. However, the high cost associated with home visits potentially limits population reach. To translate the successful evidence from the HBT into scaled-up practice applicable across the state with low-cost and broad-reach approaches, we commenced the CHAT study, to promote healthy infant feeding and active play using telephone support and Short Message Service (SMS). The CHAT trial is being conducted with 1155 mothers recruited from the third trimester of pregnancy providing intervention to 24 months of child age. The 24-month follow-up of the CHAT study will be an integral part of the recruitment process and baseline data collection for this new 2-arm RCT. By linking the two studies this study will add significant value to CHAT study by 1) examining the intervention effects at 2 years of age, and 2) conducting a new 2-arm RCT of an early obesity prevention program using a combined telephone support and SMS intervention for children aged 2-4 years. This study will address known gaps in universal obesity prevention strategies for children aged 0-2 years (CHAT study) and 2-4 years (this study) in the most efficient way possible. This unique opportunity of linking two studies will expedite project start up time and provide continuing support to the participants in the existing RCT.

Participating in physical activity reduces pain and improves function in knee osteoarthritis (OA) patients. Despite this, only 13% of people with knee OA meet the current physical activity guidelines, far lower than the national average. Identifying effective, low-cost, accessible, scalable and sustainable strategies to promote physical activity in knee OA patients is crucial. ‘parkrun’ is a free weekly mass community event that represents a novel setting with substantial untapped potential for physical activity promotion. The aim of this study is to assess the feasibility, acceptability and safety of parkrun for patients with knee OA. Participants will be asked to participate in four consecutive Saturday parkruns and complete quantitative and qualitative interviews about their experience. Participants will be followed-up after 6 months to assess longer-term impacts and adherence. Study findings will inform the development of a large RCT aiming to examine parkrun as a strategy to promote physical activity for knee OA and study its effectiveness compared to usual care. This will be the first study to examine parkrun as a novel physical activity promotion strategy for knee OA patients. This is a group of patients in need of innovative strategies to promote physical activity participation. Given the “parkrun phenomenon” has hit 17 countries around the world and consists of 400,000+ Australian members, this project has potential for broad national and international implementation.

The aims of the study are to examine the change in the physical activity and dietary behaviours of school staff, and assess the feasibility and acceptability of implementing a healthy workplace initiative in NSW primary schools. It is hypothesised that if school staff participate in a workplace physical activity and healthy eating program, then they will have improved physical activity levels and healthy eating behaviours. A cluster randomised controlled trial will be conducted with 20 primary schools (10 intervention: 10 control), located in the Hunter New England (HNE) region. The intervention will consist of two programs; i) the Premier’s Sporting Challenge; and ii) a Healthy eating program. To increase the extent of schools’ implementation of these programs, strategies recommended by the NSW Governments Get Healthy@Work Framework as well as those that have previously been utilised by the research team to successfully change the health promoting policies and practices of schools and other organisations will be implemented.

Our study will explore the effects of comparative feedback in improving post-operative rehab in patients undergoing total knee arthroplasty. This will be done by comparing outcomes in the study group of patients who receive feedback regarding their performance, with comparative feedback regarding the overall groups's. This will be compared to a control group, who only receive individual feedback, and are blinded to the performance of the rest of the group. Our hypothesis is that comparative feedback motivates patients to improve performance during post operative rehabilitation, thus improving their long term outcomes (e.g. improved joint range of motion, better limb strength, lower pain levels).

This study will test using a randomised controlled trial a brief online intervention (an Acceptance-Facilitation Intervention, AFI) designed to increase uptake and adherence to an online mental health program (myCompass 2). The primary hypotheses are that uptake of the program will be higher in the AFI + myCompass 2 condition relative to the myCompass 2 alone condition (H1), and that more participants will adhere to the intervention in the AFI + myCompass 2 condition relative to myCompass 2 alone (H2).