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Insomnia clinical trials

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NCT ID: NCT03187340 Active, not recruiting - Insomnia Clinical Trials

Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults-2

MBAT-2
Start date: June 20, 2019
Phase: N/A
Study type: Interventional

Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia

NCT ID: NCT03165370 Recruiting - Insomnia Clinical Trials

The Study of the Relationship of Insomnia in the Traditional Chinese Medicine and Western Medicine at Local Clinic

Start date: May 19, 2017
Phase: N/A
Study type: Observational

Insomnia is one of the most main diseases of civilization in the world, which chronic insomnia is up to 30% in Taiwan under the latest statistics and a common disease which appears to sleep difficultly, sleep interrupted, wake up early or wake up still tired. Long-term persistence of these symptoms will lead to the occurrence of mental illness and then affect people's emotional behavior and cognitive memory, showing that insomnia is an important modern health issues. Recently, "individual response patterns" was proposed by modern medicine. This thinking process and spirit seems to be compatible with the traditional Chinese medicine (TCM) therapy of "Differential Treatment". The purpose of this study, the Athens Insomnia Scale (AIS), commonly used to quickly screen for insomnia patients and the evaluation of Western medicine efficacy in Western medicine clinic, and investigation of Syndrome Type of TCM to find out whether with Syndrome Type of TCM and AIS in the associated factors, and confirm the necessity and importance of Syndrome Type of TCM, for future reference and basis for the development of integrated medicine. In the cross-section study with an interview on survey, sampling Miaoli County an Chinese medicine clinic, in line with standard sampling of 200 patients with insomnia were recruited. The questionnaires contained two instruments including Athens Insomnia Scale (AIS), and Syndrome Type of TCM questionnaire. Cross-table, chi-square test, variance analysis and Pearson product-moment correlation was used to find the relation.

NCT ID: NCT03151083 Completed - Insomnia Clinical Trials

Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care

Start date: May 30, 2017
Phase: N/A
Study type: Interventional

Internet-based self-help programs are personalized, self-guided interventions delivered over a computer, mobile device, or other Internet platform and focused on improving knowledge, awareness, or behavior change for a mental or physical health problem. Through previous and on-going projects at VACT, the investigators are developing a general strategy for implementing Internet-based Self-help programs in VA primary care, specifically among Patient Aligned Care Teams (PACT) and Primary Care Mental Health Integration (PCMHI) providers. An implementation strategy is defined as a systematic intervention to integrate evidence-based health innovations into usual care. The strategy the investigators propose to test consists of four core components: (1) a clinical intermediary for patient support, (2) provider/staff facilitation and education, (3) patient education, and (4) stepped-care for those requiring additional treatment. In the proposed study, the investigators will compare this strategy to a low intensity (control) strategy with respect to the implementation related outcomes of patent engagement, provider adoption through referral to the program, and patient completion, over a six-month active implementation period. The investigators will target the very common clinical problem of insomnia and use the SHUTiTM program, a 6-week self-guided program utilizing standard cognitive-behavioral therapy (CBT) techniques for the treatment of chronic insomnia. The program has been shown to improve insomnia severity and other sleep related outcomes in a number of controlled trials. The clinical effectiveness of SHUTiTM will be evaluated using clinical insomnia outcomes obtained on all patients enrolled over the 6-month active implementation periods. The purpose this study is to evaluate the preliminary (1) effectiveness of an implementation strategy for Internet-based Self-help Interventions and (2) clinical outcomes of a specific Internet-based self-help program for insomnia, SHUTiTM, in VA Connecticut outpatient primary care. The primary hypothesis is that the experimental implementation strategy the investigators are developing, relative to a control strategy, will result in higher rates of program engagement by patients, greater provider adoption through referral to the program, greater program completion, and improved patient insomnia outcomes.

NCT ID: NCT03137147 Completed - Insomnia Clinical Trials

Intervention for Sleep and Pain in Youth

I-SPY
Start date: October 1, 2016
Phase: N/A
Study type: Interventional

This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages 11-17 with co-morbid headache and insomnia.

NCT ID: NCT03117777 Withdrawn - Insomnia Clinical Trials

Group Cognitive Behavioral Therapy for Insomnia in Older Adults

Start date: October 2017
Phase:
Study type: Observational

This is a quality assurance project to evaluate a therapy program offered to patients in Sleep Disorders Clinic. Group Cognitive Behavioral Therapy for Insomnia (CBT-I) is being offered to older adults. The study will consist of analyzing outcomes of a clinical program. As part of standard clinical process, patients complete measurements of sleep, daytime functioning, fatigue, quality of life, depression and anxiety symptoms before and after the treatment. The proposed study will pool and quantitatively analyze the existing clinical data. Only those program participants who consent to have their data pooled in the data analysis will be considered research subjects. Those patients who decline to have their individual data included in the analysis will continue in the therapeutic group as per usual clinical care standards. CBT-I is a gold standard treatment for people suffering from insomnia but it is difficult to access due to a shortage of trained therapists. Insomnia prevalence increases with age and is a common sleep disturbance in the elderly. Offering the group treatment can increase access and reduce healthcare costs associated with sleep problems in the elderly.

NCT ID: NCT03110315 Completed - Multiple Sclerosis Clinical Trials

A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia

DREAM
Start date: March 28, 2017
Phase: Phase 4
Study type: Interventional

This study assesses the safety, tolerability, and efficacy of suvorexant in multiple sclerosis patients. Enrolled subjects will receive 2 weeks of treatment during treatment period 1 with either suvorexant or matching placebo (1:1). After treatment period 1, subjects will undergo a washout period of 1 week then 2 weeks of the alternate treatment (either suvorexant or placebo). The primary hypothesis is that suvorexant will provide greater improvement in sleep, as measured by symptom rating scales, compared to placebo.

NCT ID: NCT03110263 Terminated - Insomnia Clinical Trials

i-Sleep: Internet-based Treatment for Insomnia

i-Sleep
Start date: June 10, 2016
Phase: N/A
Study type: Interventional

In this study, people who suffer from insomnia will be randomized to one of three study conditions. The first group receives a multicomponent internet-based cognitive behavioral self-help intervention. The second group has access to an internet-based self-help sleep restriction intervention. The third group is a waiting control group. In both active conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of a multicomponent internet-based cognitive behavioral self-help intervention as well as a stand-alone internet-based self-help sleep restriction intervention for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and 8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control group get access to the internet-based cognitive behavioural self-help intervention and also fill out questionnaires at 6-months post-randomization.

NCT ID: NCT03085446 Completed - Insomnia Clinical Trials

Insomnia in Older Adults: Impact of Personalized, Diet-Induced Alterations in the Microbiota

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

Insomnia is a chronic mental health condition characterized by difficulty initiating and maintaining sleep with a prevalence of over 50% in Israeli adults ages 65 and above. It is associated with increased risks for chronic illnesses (e.g., cardiovascular disease), poor mental health (e.g., anxiety and depression), functional limitations, and cognitive decline. Available pharmacological and behavioral treatments focusing on reducing nighttime hyper-arousal offer limited success, and it appears that there is no "one size fits all" treatment for late life insomnia. Mounting evidence suggests that sleep is related to metabolic status, however, studies on the associations between sleep and dietary patterns are surprisingly scarce. The ability of gut microbiota to communicate with the brain is emerging as an exciting concept in health and disease and provides the rationale for the present project. Findings demonstrate that gut microbiota modulates mental capacities such as brain plasticity and cognitive functions in older adults, as well as stress related mental illness. The composition of the intestinal microbiota in older people (>65 years) differs from the core microbiota and diversity levels of younger adults. With age, gut populations of beneficial microbes show a marked decline. As diet has been shown to markedly promote microbiota biodiversity, it is hypothesized that diet-induced changes in microbiota may provide a novel approach for the treatment of mental health. Although insomnia is strongly linked to mental health (e.g., depression and anxiety), as well as cognitive and motor performance, the effects of diet-induced microbiota alterations, based on individual microbiota composition, on late life insomnia is currently unknown. The proposed project will be the first to investigate the associations between gut microbiota and sleep, and assess the potential of a six-months personalized, diet-induced microbiota alterations intervention (PDM), aimed to improve insomnia in older adults. We will also look at cognitive, motor and mental health factors as possible mediators in this relationship. Specifically, we will test the associations between microbiota composition and sleep quality, both cross-sectionally and longitudinally, i.e., following a PDM intervention; evaluate the impact of PDM on changes in cognitive, motor and mental health functions; and identify the mediating roles of changes in cognitive, motor and mental functioning on the effects of a PDM intervention on sleep quality. Findings are expected to improve the quality of life of older adults by enhancing their sleep, functional status, mental health and overall wellbeing.

NCT ID: NCT03075241 Completed - Alzheimer's Disease Clinical Trials

Z-Drugs for Sleep Disorders in Alzheimer's Disease

Start date: October 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Zolpidem and Zoplicone are efective in the treatment of sleep disorders in Alzheimer's disease (AD)

NCT ID: NCT03072745 Completed - Chronic Pain Clinical Trials

Insomnia and Cognitive Performance in Chronic Pain

Start date: January 1, 2011
Phase: N/A
Study type: Interventional

The aim of the present study is to examine cognitive function in a patient population with complex chronic pain to test the hypothesis that insomnia severity on its own predicts objective cognitive function, and that a correlation is not better explained by comorbid depression or anxiety, morphine equivalent daily dose, or the level of pain itself.