View clinical trials related to Insomnia.
Filter by: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.
The investigators are doing this research study to find out if suvorexant (Belsomra) can help people with bipolar depression when added to their usual treatment. The investigators also want to find out if suvorexant (Belsomra) is safe to take without causing too many side effects in people with bipolar disorder. Suvorexant (Belsomra) is approved by the U.S. Food and Drug Administration (FDA) to treat insomnia. It has not yet been studied in people with bipolar disorder who have problems sleeping. This research study will compare suvorexant (Belsomra) to placebo. The placebo looks exactly like suvorexant (Belsomra), but contains no suvorexant (Belsomra). During this study participants may get a placebo instead of suvorexant (Belsomra). Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. This study has two parts, each lasting 6 weeks. During each part, participants may receive either Belsomra or placebo. Some participants will receive suvorexant for both parts, some will receive placebo for both parts, and others will receive suvorexant during one part and placebo during the other part. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. This study is open to people with bipolar disorder who have trouble sleeping. Bipolar disorder is a brain disorder associated with episodes of mood swings ranging from depressive lows to manic highs. About 80 subjects will take part in this research study. All subjects will be enrolled at Massachusetts General Hospital (MGH).
Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.
Insomnia affects 67-88% of chronic pain patients. SPIN II is a randomized controlled clinical trial that will compare the effects of two cognitive behavioral sleep treatments in women with fibromyalgia and insomnia. This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia.
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.
Randomized Control Trial (RCT), were healthy but sedentary women are selected in their first trimester of pregnancy. This RCT has two interventions arms (pedometer plus a goal of 11,000 steps / day and pedometer without goal) and a control group arm, without the use of pedometer. The main objective is to promote physical activity in pregnancy decreasing the prevalence of insomina at their third trimester of pregnancy.
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.
The purpose of this research is to test whether Mindfulness-Based Therapy for Insomnia (MBTI) significantly reduces symptoms of insomnia and cognitive arousal in patients with treatment-resistant insomnia.
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.