View clinical trials related to Insomnia.
Filter by:The study is a three phase sequential study of the medical treatment of insomnia with zolpidem. All participating subjects will receive one month of standard nightly treatment. If the subject has a positive treatment response they continue in the study and are randomized to one of four conditions: intermittent dosing (3-5 pills week, full dose), or one of three variable dose conditions (nightly pill use where any given pill is a variable dose). Standard treatment will last for 4 weeks. The experimental phase will extend over two periods. The first period will last for 12 weeks. The second period will last for 36 weeks. Both periods include: • Taking a pill 30 minutes prior to bedtime. In one case, this will involve taking 3-5 pills per week. In the remaining condition pills will be taken on each and every night. Depending on the specific group that the subject is assigned to, they will either receive 10mg or 5mg of zolpidem (variable by age and sex) or a variable dose of zolpidem on a nightly basis (range from 0 mg to 10 mg per night). - Completing a sleep diary each day; - Completing 6 to 7 questionnaires each week; - A monthly visit to Penn to return your medication foil packs and to receive a new foil pack with the next month of medication. During Phases 3&4, the subject will be asked to undergo quarter annual physicals so that we can optimally track their health and wellbeing. The physicals will involve standard vitals measures (e.g., temperature, blood pressure, height and weight, etc.) and, based on the judgement of the research clinician, may involve an EKG and blood and urine chemistries. If the subject does not experience a treatment response or (following a treatment response) experiences a relapse of insomnia, they will not continue in the study but will be given the opportunity to be treated with Cognitive Behavioral Therapy for Insomnia (CBT-I) at no cost. Assessments of the subjects clinical status will be based on your daily sleep diaries and weekly questionnaires.
Patients with multiple sclerosis (MS) struggle on a daily basis with accompanying, "Invisible" symptoms like primary fatigue, pain and emotional-cognitive disorders. With the disease progression, these symptoms only intensify, and in combination with basic physical symptoms, quality of life (QOL) rapidly decreases. An important goal of researchers and clinicians involves improving the QOL of individuals with MS, and the exercise therapy represents potentially modifiable behavior that positively impacts on pathogenesis of MS and these "Invisible" symptoms, thus improving the QOL. However, the main barrier for its application is low motivational level that MS patients experience due to fatigue with adjacent reduced exercise tolerability and mobility, and muscle weakness. Getting individuals with MS motivated to engage in continuous physical activity may be particularly difficult and challenging, especially those with severe disability or Expanded Disability Status Scale (EDSS 6-8). Till now, researchers have focused their attention mainly on the moderate or vigorous intensity of exercise and on cardiorespiratory training in MS patients to achieve improvements in daily life quality, less indicating the exercise content, and most importantly, breathing exercises. In addition, it is investigators intention to make exercise for MS patients more applicable and accessible, motivational and easier, but most important, productive. Investigators think that MS patients experience more stress with aerobic exercise or moderate to high intensity program exercise, and can hardly keep continuum including endurance exercise, or treadmill. Hypothesis: Investigators hypothesis is that 8-weeks of continuous low demanding or mild exercise program with the accent on breathing exercise can attenuate primary fatigue, pain, headaches, emotional-cognitive and sleep dysfunctions in MS patients and provide maintenance of exercise motivation. Investigators also propose that important assistant factor for final goal achievement is social and mental support of the exercise group (EDSS from 0-8) led by a physiotherapist. This will help to maintain exercise motivation and finally make better psychophysical functioning, and thus better QOL.
Introduction: Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory joint disease that attacks peripheral joints and posterior tissues. More than half of patients with RA also have insomnia, which can modify pain, fatigue, quality of life and comorbidities. Traditional treatment of insomnia is often based on pharmacological drugs, however cognitive behavioural therapy for insomnia (CBT-i) have shown effect in insomnia with less side effects. It remains to determine whether CBT-i can be effective in patients with RA. The primary objective of this Sleep-RA trial is to assess the efficacy of CBT-i on sleep efficiency in patients with RA at week seven. Key secondary objectives are to estimate the clinical efficacy of CBT-i on wake after sleep onset, total sleep time, sleep onset latency, insomnia, sleep quality, fatigue, RA impact of disease and depressive symptoms at week 26. Methods & Analysis: Sleep-RA will be carried out as a randomised controlled trial (RCT) with randomised assignment and two-group parallel design. Patients with RA and insomnia are randomly allocated 1:1 to the intervention group or the control group. The intervention group will once a week for six weeks receive group-based CBT-i, a multi-component intervention of; sleep education, stimulus control, sleep restriction, cognitive therapy and relaxation. The control group will continue treatment as usual (insomnia will remain untreated). Follow-up assessments will be carried out seven and 26 weeks after baseline. The primary outcome is sleep efficiency measured with polysomnography at week seven. Key secondary outcomes are: wake after sleep onset, total sleep time, sleep onset latency, insomnia, sleep quality, fatigue, RA impact of disease and depressive symptoms from baseline to week 26. Polysomnography, actigraphy and Disease Activity Score 28-Joint Count C reactive protein will be assessed by medical staff blinded to group allocation. The project manager will assist the participants with questionnaires and conduct the intervention of CBT-i and will therefore not be blinded to group allocation. With a sample size of 60 patients the trial will have more than 85 % power to detect a mean difference between groups of 6 % points in the primary outcome of sleep efficiency measured at week seven and a reasonable statistical power to explore the clinical efficacy according to the eight key secondary outcome measures at week 26. Ethics and dissemination: Ethics approval has been obtained from The Committee on Health Research Ethics. We plan to submit a manuscript with the content of this protocol, and at least one scientific manuscript on the results of the primary and key secondary outcomes to a peer-reviewed journal. Results will be presented at conferences, community and consumer forums and hospital grand rounds.
A randomized controlled trial is proposed to compare the effectiveness of workshop-based and self-Help cognitive behavioral therapy for insomnia (CBTI), and sleep hygiene education (SHE) to treat insomnia in Hong Kong adolescent and adult patients, in terms of alleviation of insomnia severity, reduction in associated insomnia symptoms/ complications, and enhancement in quality of life. Insomnia is prevalent in Hong Kong and can cause severe impacts on patients and society, but there is a dearth of related research in the local population. Therefore, it is significant to conduct this study. A total of 210 participants aged > 18 with insomnia will be recruited and randomized into 3 groups to receive one of the 3 treatments. Outcomes will be measured using relevant questionnaires filled in at the baseline, 6 and 12 weeks afterwards. The results obtained will be compared within each group and among the 3 groups using statistical testing to determine the most effective treatment option for insomnia.
Musculoskeletal (MSK) pain is a major public health concern. Approximately one in four consult their general practitioner (GP) with a musculoskeletal problem during the course of a year, making it the largest diagnostic group. Modifiable factors including affective disorders (e.g. anxiety and depressive symptoms) and sleep problems may be important prognostic factors for MSK pain. However, there is a lack of prospective research examining the interaction between these conditions in patients with MSK pain in a GP-setting.
This research study will examine the effects of the Transcendental Meditation (TM) technique on academic physician burnout, depression, insomnia, perceived stress, and resilience through a mixed methods approach.
Insomnia is a common sleep disorder, with three main symptoms: difficulty in initiating sleep, difficulty in maintaining sleep, and/or waking up early without ability to return to sleep. Insomnia can contribute to metabolic dysfunction, which can lead to type 2 diabetes (T2D). Diabetes self-care behavior (DSCB) is important in attaining and maintaining glycemic control, which worsens as a result of fatigue. People with insomnia usually suffer from fatigue and inconstant sleep schedule, which negatively influence quality of life. However, the additive effect of behavioral sleep intervention on diabetes outcomes and health status in people with T2D is unknown. Therefore, The overall purpose of this study is to investigate the impact of both insomnia symptoms and CBT-I on people with T2D. The central hypotheses are that people with T2D and insomnia symptoms will have worse sleep, diabetes measures and self-reported outcomes compared to people with T2D only, which might be adjusted with CBT-I.
A substantial number of children and adolescents sustain a mild traumatic brain injury (mTBI) each year. Although research supports that the vast majority of youth will recover quickly and return to normal functioning, some adolescents continue to report problems long after the injury. Disturbed sleep, notably trouble with sleep onset and sleep maintenance, is a frequently reported problem in those with slow recovery from a mTBI. Poor sleep is also associated with cognitive complaints, mood disturbance, and lower quality of life. Despite the identification of sleep disturbance as a problem associated with slow recovery, there are very few treatment options. Cognitive-behavioural therapy for insomnia (CBT-I) has shown promise in children and adolescents as an effective treatment for sleep disturbance, although it has yet to be applied to the adolescent mTBI population who also present with sleep problems. The objective of this study is to examine the treatment of sleep disturbance using cognitive-behavioural therapy for insomnia (CBT-I) in those adolescents who have a protracted recovery from their mTBI. This represents a novel treatment option for this patient population and is anticipated to improve outcomes and quality of life.
Sleep can affect frequency and occurrence of interictal spikes and occurrence, timing, and threshold of seizure. Epilepsy can worsen sleep architecture and severity of sleep disorders. Thus, a vicious cycle is set. Certain epilepsy syndromes are so intertwined with sleep that they are considered sleep-related epilepsies. Poor sleep in epilepsy is multifactorial and is worsened by poorly controlled seizures. App-delivered intervention has shown promise as a method to overcome health issues; however, the long-term effectiveness has not been proven in epileptic patients with chronic insomnia.
The Healthy Patterns Study intervention is a home-based activity intervention designed to improve symptoms of circadian rhythm disorders (CRD) and quality of life (QOL) in home-dwelling persons with dementia. We will use a randomized two-group parallel design of 200 people with dementia and their caregivers assigned to intervention or attention control groups.