A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary...
Sleep Initiation and Maintenance Disorder; ElderlyMental Disorder4 moreThe current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH 900265, MK-8265) to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients.
Melatonin Treatment After Laparoscopic Cholecystectomy
Postoperative ComplicationsFatigue1 moreCircadian disturbances occur after surgery. A double blinded, placebo controlled randomized clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep disturbances and general wellbeing.
Brain Energy Metabolism and Sleep in Adults
Alzheimer DiseaseMild Cognitive Impairment3 moreThe three primary goals of this pilot will be followed by a secondary goal to test if dental intervention improves brain health in terms of sleep and cognition. The primary and secondary goals are Explore the ratios of brain energy (ATP/PCr, Pi/PCr) and phospholipids (PME/PDE) metabolites as measured by magnetic resonance spectroscopy at 7 Tesla, and compare the differences in them with the performance of episodic memory, attention, language, and executive functions (abstraction, reasoning, verbal fluency, working memory) in three groups: cognitively normal adults, mild cognitive impairment (MCI) and Alzheimer's disease (AD). Investigate the differences in sleep patterns measured by the ratio sleep quality index (Stable/ Unstable sleep) in cognitively normal adults, MCI and AD and its relation to the performance of episodic memory, attention, language, and executive functions (abstraction, reasoning, verbal fluency, working memory) in three groups. Investigate the differences in the variations of two genes, APOE-E4 and ABCA7, in relationship to the changes in the brain energy metabolites and its relation to the performance of episodic memory, attention, language, and executive functions (abstraction, reasoning, verbal fluency, working memory) in those with cognitively normal adults, MCI and AD. Investigate if dental intervention improves sleep patterns and overall cognitive behavior in the three cohorts.
hBET for Pain and Sleep Feasibility
PainChronic1 moreLong-term pain affects one-third of the United Kingdom population and can be very disabling. People experiencing long-term pain often suffer from disturbed sleep because of their pain symptoms, and disturbed sleep can then make their pain symptoms worse. Managing long-term pain is also very costly to the National Health Service. The most common treatment is prescribed medicines, but these do not always work and can have serious side-effects for some patients. The investigators have been developing an alternative approach for treating long-term pain. This approach uses simple non-invasive tools to promote some kinds of brain activity over others. It involves patients using headphones to listen to some specific sounds, or a headset with lights flashing at particular frequencies. The studies undertaken so far seem to show that doing this can change how the brain responds to pain. It potentially offers an inexpensive yet effective way of reducing pain and improving sleep for patients with long-term pain. There are a few small studies that support this approach and more work is needed. The next step is to find out whether these tools can be reliably used in home settings, how people feel about using this approach, and to gather information to design a larger trial of this technology. Therefore the aim of this study is to test the suitability and acceptability of these home-based tools with individuals with long-term pain. Up to 30 participants with long-term pain and pain-related sleep disturbance will use the tools for at least 20 minutes at bed time every day for 4 weeks. The investigators will interview them to ask about their experiences of using the tools, and their feedback and suggestions on how the approach should be developed. The investigators will measure changes in the nature of participants' pain, sleep, fatigue and mood. These findings will inform the planning and design of a future much larger study to test this technology. The investigators will make sure that findings from this study are shared widely within the National Health Service and beyond among patient groups, professionals, charities, specialist centres and commissioners.
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
Multiple SclerosisSleep disturbance, especially insomnia (i.e., difficulty initiating and maintaining sleep), affects over half of people with MS. Cognitive behavioral strategies have been shown to improve sleep quantity and quality in several neurologic populations (e.g., traumatic brain injury, Parkinson's disease), and cognitive behavioral therapy for insomnia (CBT-I) is considered the first-line insomnia treatment for adults in the general population. Although cognitive behavioral interventions have historically been delivered in-person, a growing body of literature supports telephone- and internet-delivered approaches. However, more work is needed to understand the effects of internet-delivered CBT-I on patient-reported and objective outcomes. This study is a pilot randomized controlled trial to test the preliminary effects of iSLEEPms, a CBT-I-based online intervention with telephone support for individuals with MS. After completing a baseline assessment (Week 1), 90 participants with MS will be randomized (1:1) to four weeks (Weeks 2-5) of iSLEEPms (intervention group) or treatment as usual (TAU; control group), and complete post-treatment (Week 6) and follow-up (Week 12) assessments. iSLEEPms participants will complete daily sleep diary forms and weekly online educational modules. TAU participants will continue usual care without access to the iSLEEPms materials. The primary outcomes will be patient-reported and actigraphic measures of sleep quality and quantity. Secondary outcomes will be treatment satisfaction, adherence, and integrity (iSLEEPms group only). Exploratory outcomes will be fatigue symptoms, depression symptoms, and cognitive function.
The CANabidiol Use for RElief of Short Term Insomnia
Sleep DisturbanceInsomnia5 moreThis study aims to investigate the effect of 50 mg and 100 mg per day oral CBD product versus a placebo over 8 weeks on insomnia severity in adults aged 18-65 years old with insomnia symptoms.
Improving Sleep Health in Adults With Overweight or Obesity
Sleep DisturbanceSleep Wake Disorders1 moreThis study will examine the feasibility and acceptability of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in adults with poor sleep and excess weight. Additionally, the study will explore if TranS-C improves sleep health and cardiovascular outcomes.
An Integration of Tai Chi and Repetitive Transcranial Magnetic Stimulation for Sleep Disturbance...
Sleep DisturbanceThe investigators designed an RCT aimed at 1) exploring the effectiveness of combining TC with rTMS for synergistically improving sleep disturbances in community-dwelling older adults, 2) investigating the mediating roles of arousal states as the underlying mechanism of the potential beneficial effects, and 3) evaluating the feasibility and safety to inform the clinical practice. The investigators hypothesized that integrating TC and rTMS can affect the different dimensions of the arousal system to improve sleep disturbances with optimized clinical outcomes.
Anxiety, Stress and Sleep Problems in People With Early Onset Dementia
Early Onset DementiaYoung Onset Dementia7 moreThe aim of this study is to detect and assess needs of people with early onset dementia regarding anxiety, stress and sleep implement a 6 week intervention pilot study in wich weekly (hourly) sessions are implemented in day care settings in order to decrease anxiety, stress and sleep problems in people with early onset dementia
What Are Persistent Lower Back Pain Patients' Views of Sleep Health Within an Outpatient Musculoskeletal...
Persistent Lower Back PainSleep Disturbance2 moreThe goal of this qualitative is to understand the views and opinions of patients with persistent lower back pain patients who are awaiting physiotherapy treatment with regards sleep their sleep health. The main questions it aims to answer are: Identify whether Patients with persistent lower back pain awaiting physiotherapy consider sleep health relevant to their condition. Understand whether persistent lower back pain patients awaiting physiotherapy consider sleep health within the remit of Physiotherapy? Understand how persistent lower back pain patients may want sleep health to be assessed or managed within an outpatient musculoskeletal Physiotherapy Setting? Participants will undertake one semi structured interview and complete two secondary outcome measures: Pittsburgh Sleep Quality Index and Pain, Enjoyment of Life and General Activity Scale. Data will be analysed via Thematic Analysis.