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Microvascular Decompression for Unilateral Pulsatile Tinnitus- A Prospective Randomised Multicenter Study
Tinnitus is a common presentation whereby patients experience a ringing or buzzing sound in the absence of external noise, and these symptoms can be quite debilitating for the affected individual. Pulsatile tinnitus represents a subtype that may be caused by compression exerted by an arterial loop or vein against the vestibulocochlear nerve as it exits the brainstem en-route to the inner ear. Microvascular decompression (MVD) is already routinely performed for the treatment of other neurovascular compression syndromes with positive results, including trigeminal neuralgia (compression of trigeminal nerve), hemifacial spasm (compression of facial nerve) and glossopharyngeal neuralgia (compression of the glossopharyngeal nerve). There is a limited volume of worldwide literature which suggests that surgery (microvascular decompression of the acoustic nerve) to treat this condition may be of benefit in selected cases. The evidence is limited to small case series, and several systematic reviews, but no randomised trials have been performed to date. The objective of this study is to go beyond what we already know from the limited literature by carrying out a randomized multi-centre controlled trial, investigation to results of microvascular decompression of the acoustic nerve. The primary endpoint is treatment efficacy compared to control. The secondary endpoints examine the safety and prognostic factors that would lead to a more favourable outcome following surgery. A small case series of patients recruited from two large health networks in Melbourne (Melbourne Health and Monash Health) will be selected according to the type and severity of their tinnitus. Inclusion criteria include: 1) patients with unilateral pulsatile tinnitus, 2) there is an identifiable compression of their vestibulocochlear nerve by an arterial loop or vein on pre-operative imaging, 3) have suffered from pulsatile tinnitus for > 12 months, 4) have attempted other conservative measures, 5) age 18-75 years and 6) able to consent for participate in the study. Patients meeting the inclusion criteria and who consent to participation in the study will be randomised to either continue with 1) best medical management (control arm) or 2) undergo microvascular decompression via a retrosigmoid craniotomy at either of the two study centres (intervention arm). This surgery involves a general anaesthetic, and posterior fossa craniotomy, identification of the vestibulocochlear nerve and compressing vessel, and removing this vessel away from the nerve to relieve the pressure on it. The primary outcome measure is the surgical efficacy for treating pulsatile tinnitus. Based off the existing literature, it is hypothesised that at least 60% of participants will experience some symptom relief post-surgery.
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Do omega-3 fatty acids affect the absorption of lutein and zeaxanthin in humans?
Baseline data will be obtained from consenting participants at the first screening visit before enrolment into the study. This will occur after eligible participants aged 19 -65 years have expressed interest via e-mail in participating in this study. Participants will be screened using an online demographic characteristics questionnaire (age in years, gender status, ethnicity, family history of AMD, bowel, atrophic, cardiovascular, pancreatic disorders, diabetes and gastrointestinal disease, current or recent supplement use, smoking status, alcohol intake, current or recent use of medications that may affect lipid absorption, currently on a medically related special diet) will be collected. While physical activity level including body mass index and fat will be determined using a body composition analyzer. Initial venous blood sample (20ml) for estimating lutein and zeaxanthin (using high performance liquid chromatography) and omega 3 fatty acids (using gas chromatography – mass spectrometry) including the oxidative stress level (using flow cytometry, a tool used for single cell analysis of immune system) will be collected. Other information on the history of bowel disease, cardiovascular disease, hepatic, diabetes, gastrointestinal or renal disease will be assessed. Anthropometric indices (height, weight, body mass index) will be obtained. After collection of baseline data, study participants will commence a 6-day wash-out. Within this period, they will follow a low carotenoid-omega-3-diet based on the list of foods provided and provide venous blood (day 1 and 7). Participants will be contacted once every week via text/e-mail during the wash-out period to ensure they follow the low carotenoids and omega 3 fatty acid diet. If any participants were not compliant with the low carotenoid and omega 3 fatty acid diets, the wash-out period will either be extended for another week or discontinued from the study. On completing the 7-day wash-out period, participants will commence a 12-day intervention. The control group will receive L+Z supplement and the intervention group will receive L+Z and omega-3-supplements. The changes in lutein and zeaxanthin levels in the blood after the intervention will be recorded; the area under the curve for serum levels of lutein and zeaxanthin with and without omega 3 supplementation will be used for calculation of bioavailability.
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Examining the efficacy of a sleep-wake management tool for shift workers
More than 15% of the Australian workforce is employed in shift work. However, non-standard work hours may lead to sleep disturbances and circadian misalignment, where our body-clock is not in sync with actual sleep-wake behaviours. This can have adverse effects on overall health and wellbeing, including cognitive performance. In this study, we seek to examine whether using evidence-based strategies delivered via an app, developed in consultation with members of the Australian Defence Force can be a practical way of supporting sleep, mental health and cognitive performance in shift workers. We aim to assess whether the digital tool is appropriate for daily use and whether it has an impact on sleep, mental health and performance of air traffic controllers. Results from this study will help us understand the app's initial efficacy for future testing with larger groups of shift workers.
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Trial of smart home, mobile or wearable assistive technology used by people with Acquired Brain Injury
Acquired brain injury (ABI) frequently results in cognitive impairment in the domain of executive function. These issues can have significant impact on independence. There are a growing range of smart home, mobile and wearable technologies available that may address these needs. These technologies hold potential to improve level of independence and reduce the costs of care after ABI. However, evidence to select and guide their use to compensate for the functional impact of cognitive impairment is lacking. This study will evaluate the efficacy of assistive technology on executive function outcomes using a single-case experimental design protocol with a group of individuals with an ABI.
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The Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) Project Pilot Feasibility Study
The Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) aims to enable older adults to effectively engage with Advance Care Planning (ACP), in the home care setting. Advance care planning is the process by which older adults, or people who are experiencing chronic disease, terminal illness (including cancer) and/or are at risk of dementia and similar conditions can provide instructions to their carer/s about their main preferences and goals for future care, should they reach a stage where they may not be able to make these decisions on a day-to-day basis. Who is it for? You may be eligible for this study if you are aged 65 years or older (50 years or older for Aboriginal or Torres Strait Islander people), you have had a previous aged care assessment team (ACAT) assessment, you are living in a private residence (own or rented dwelling, including retirement village or other co-operative housing, but NOT a residential aged care facility) and you are receiving home care services from one of the participating aged care provider study sites (Home Care Package Level 1-4, or commensurate self-funded service). Participants who meet these criteria and have been diagnosed with cancer will also be eligible. Study details Participants who choose to enrol in this study will be allocated to one of two groups. The first group will receive the EARLI program which involves meeting with a member of the research team every fortnight for up to 10 weeks. Each meeting is expected to last up to 1 hour and these participants will be guided through the ACP process and given an opportunity to discuss their goals and preferences with members of their aged care and primary care (GP or other specialist) teams. The second group will be given one 30 minute session which provides a brief introduction to ACP and directs participants to available resources. The allocation into the first or second group is randomised (like flipping a coin) - each aged care provider study site will be randomly allocated to recruit for the first or second group for 2 months, before swapping over. Each participant will be invited to participate in just one of the groups, with the allocation depending on which stage of the process the aged care organisation is in at the time the participant is recruited to the study. The overall duration of participation in this study will be 3 months from the date of enrolment. It is hoped this research will determine whether it is possible to deliver the EARLI program in the Australian home care setting and gather initial details on the effect of these modules on participants' confidence in making decisions. If the current study is positive, these results will be used to guide a larger clinical trial that may enrol participants across multiple sites in Australia.
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The effect of personalised lighting recommendations on sleep and alertness in shift workers
Shift work often leads to poor sleep and wellbeing, fatigue and increased risks of road and workplace accidents. Employees are often impacted differently by shift work and the individual pattern of light exposure plays a crucial role in determining how the body clock responds. There is a need for personalised approaches to the management of sleep and health in shift workers. The project will provide personalised lighting recommendations to shift the timing of worker’s body clocks and help them better adapt to their specific shift work schedules. The strategic light exposure, based on scientific evidence, will target improved sleep, alertness, performance, and wellbeing. Shift workers will participate for up to 8 weeks, depending on their shift schedule. For one shift rotation (first 3 weeks of study), participants will complete short daily questions on sleep and alertness via a smartphone app, and wear a wrist-watch activity monitor and small pendant on their lapel to monitor sleep and light exposure. They will also have their body clock timing measured twice. Based on this monitoring, each participant will be provided with personalised recommendations on when to seek light and when to avoid light during a subsequent shift rotation (last 3 weeks of study). Lighting devices will be provided that suit specific working conditions (e.g., light-emitting glasses or light boxes at work stations). Monitoring of sleep, alertness, light and body clock timing will be repeated to demonstrate the impact of the personalised recommendations.
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A physiological study of the effect of alpha-melanocyte stimulating hormone (alpha-MSH) on glucose tolerance in people with type 1 diabetes
In healthy adults, alpha-MSH increased glucose clearance and spared insulin during an oral glucose tolerance test, while having no effect during a fasting infusion. We now aim to understand whether alpha-MSH increases glucose clearance during an oral glucose tolerance test in people with type 1 diabetes. If glucose clearance is improved, a new adjunctive treatment for type 1 diabetes could be developed to improve glucose control and lower insulin doses. Participants will receive two treatments; alpha-MSH and placebo, through an intravenous infusion lasting 3.5 hours at two separate visits. Those using an insulin pump will set it to a temporary basal rate immediately prior to the infusion. The first 30 minutes of the infusion will be fasted to assess the effects of alpha-MSH on basal glucose. 30 minutes after commencing the infusion, those that use bolus insulin will administer a dose of their usual bolus insulin that is half the usual amount that they would give to cover the glucose load. Participants will then drink 75g of glucose over 5 minutes. Blood samples will be collected at -30, 0, 15, 30, 60, 90, 120 and 180 minutes relative to consumption of the glucose drink and analysed to determine whether alpha-MSH increases glucose clearance. At the end of the 3.5 hour infusion, participants will be offered a meal and monitored.
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Comparing Vaginal Hysterectomy and Manchester Procedure for uterine prolapse
The Manchester Procedure (MP) and vaginal hysterectomy with vault suspension (VH) are two surgical options for the treatment of pelvic organ prolapse (POP). The evidence of benefit is currently limited to one prospective trial and several retrospective reviews. The two procedures have been studied in isolation though much more data exists for VH. Recent Danish registry data in a matched cohort study (n=590) suggested prolapse outcomes after Manchester repair were better than those after vaginal hysterectomy with vault suspension. In addition to the question of effectiveness of the procedure, the economic benefits of MP versus VH have been studied in the international literature. Costs for the first 20 months after the operation were higher in the VH group when analyzing the primary operation only, and higher still when including subsequent activities within 20 months. Given the MP is performed far less frequently in Australia, presumably due to patient selection and surgeon preference, there is a benefit for the local and international community to learn more about the differences in outcome between the procedures. Local data that shows equivalent outcomes may encourage increased uptake of the procedure which may lead to health gains for the patient and improved economic outcomes for hospitals.
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The effectiveness of multi-disciplinary pain management and motivational interviewing for people with chronic pain
Chronic pain is the leading cause of disability and disease burden globally. Multi-disciplinary pain management has shown effectiveness in chronic pain however the clinical importance of the observed effects is questionable. People with nociplastic dominant pain are a challenging group, with low self-efficacy where facilitation of graded activity/exercise and reinforcement of healthy behaviours are likely to be helpful. Motivational interviewing may be a useful adjunctive treatment for improving therapeutic alliance, barriers to engaging in graded activity/exercise, adherence and clinical outcomes including self efficacy. This trial evaluates whether in people with nociplastic dominant chronic pain, multi-disciplinary pain management plus motivational interviewing is more effective than multi-disciplinary pain management alone on improving pain self-efficacy and pain interference.
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The effect of dishabituation on hypoglycaemia awareness in patients with type 1 diabetes and impaired hypoglycaemia awareness.
People with both Type 1 diabetes (T1D) and impaired awareness of hypoglycaemia (IAH) have a diminished ability to respond to hypoglycaemia and are hence more susceptible to severe hypoglycaemia. IAH occurs in at least 20-25% of individuals with T1D, and adds to the burden of the disease. The novel concept that IAH develops as a result of an adaptive learning response referred to as habituation. This theory suggests that the progressive diminishment of the counterregulatory responses (CRR) to hypoglycaemia following repeated exposure to hypoglycaemia is consistent with the principal features of a habituated response, and provides an explanation for IAH. Importantly, a habituated response can also be, at least temporarily, reversed. Presentation of another (usually strong) stimulus results in recovery of the habituated response by the introduction of a novel (heterotypic) stimulus, a process known as Dishabituation. High-intensity exercise (HIE) was shown to provide an effective dishabituation stimulus in a rodent model of IAH. In this pilot study, we seek to assess the acceptability and feasibility of HIE as a home-based intervention for people with IAH. The study will also aim to provide preliminary evidence of whether regular exposure to HIE can be used as a home-based therapeutic intervention to restore hypoglycaemia awareness in individuals with IAH.