View clinical trials related to Primary Insomnia.
Filter by:The goal of this project is to examine the neurophysiology of hypersomnia during sleep and wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders, and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to determine if this decreases daytime sleepiness in these patients. The primary study hypotheses are that individuals with hypersomnolence will have reduced slow wave activity (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent patients will increase SWA during sleep, reduce theta/alpha activity during wake, and improve subjective sleepiness.
A six-month study to determine the safety and efficacy with an additional open-label extension to determine the long-term safety of eszopiclone in the treatment of adult subjects with primary insomnia.
Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily from mental health disorders, such as anxiety disorders and depression. Cognitive behavior therapy (CBT) has been shown to be an effective treatment of these disorders. Despite the strong evidence for CBT there is a lack of evidence-based psychological treatment in primary care. For various reasons, the progress of research has not affected clinical practice. For successful implementation of CBT in primary care cost-effective therapies, access to therapists with proper training and supervision, evidence-based manuals and management that support the implementation is needed. Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All patients are first treated with self-help CBT (N = 400). Patients that do not improve after treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based on published studies 2/3 is expected to be improved after self-help and therefore do not undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to individual CBT (N = 67) or continued self-help treatment (N = 67).
Background: Common mental illness, such as anxiety disorders and depression, is the main cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be effective in alleviating target symptoms of these disorders, but its effect on sick leave rates has not been sufficiently addressed. The investigators have developed an intervention called return to work (RTW), which is based in cognitive behavioral theory, that has a primary aim of helping sick-listed patients with common mental illness return to work. This new treatment has not been evaluated in a randomized controlled trial. Aims: The aim of this study is to investigate the effect of CBT and RTW for subclinical common mental illness in a randomized controlled trial conducted in primary care. Participants will be randomized to diagnosis specific CBT (n=50), RTW (n=50. Main outcomes are days of sick leave and clinician severity rating of psychiatric symptoms. This study could contribute to new knowledge regarding how to best treat patients on sick leave with mild common mental illness.
Chronic insomnia is a prevalent disorder associated with increased health care costs, impaired functioning, and an increased risk for developing serious psychiatric disorders. Cognitive-behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications are the most widely supported approaches for insomnia management. Unfortunately, few studies have compared the psychological/behavioral therapies and BzRAs for insomnia treatment. Moreover, insomnia treatment studies have been limited by small, highly screened study samples, fixed-dose and fixed-agent pharmacotherapy strategies that do not represent usual adjustable dosing practices, relatively short follow-up intervals, and reliance on self-report or polysomnographic (PSG) sleep parameters as outcomes, rather than on more clinically relevant indicators of remission. Finally, studies have yet to test the benefits of treatment sequencing for those who do not respond to initial their insomnia therapy. This multi-site project will address these limitations. Two study sites will enroll a total of 224 participants who meet broad criteria for a chronic insomnia disorder, and a sizeable portion (60%) of this sample will have insomnia occurring comorbid to a psychiatric disorder. Participants will be evaluated with clinical assessments and PSG, and then will be randomly assigned to first-stage therapy with an easy-to-administer behavioral insomnia therapy (BT) or zolpidem (most widely prescribed BzRA). Centrally trained therapists will administer therapies according to manualized, albeit flexible, treatment algorithms. Initial outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the next 12 months on maintenance therapy. Those not achieving remission will be offered re-randomization to a second, 6-week treatment involving pharmacotherapy (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy-CT). All participants will be re-evaluated 12 weeks after protocol initiation, and at 3-, 6-, 9-, and 12-month follow-ups while continuing their final treatment. Insomnia remission, defined categorically as a score < 8 on the Insomnia Severity Index, will serve as the primary outcome for treatment comparisons. Secondary outcomes will include sleep diary and PSG sleep measures; subjective ratings of sleep and daytime function; adverse events; dropout rates; and treatment acceptability. Our over-arching goal is to obtain new information that aids in the development of clinical guidelines for managing insomnia sufferers with and without comorbid psychiatric conditions.
Background: Common mental illness, such as anxiety disorders and depression, is the main cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be effective in alleviating target symptoms of these disorders, but its effect on sick leave rates has not been sufficiently addressed. The investigators have developed an intervention called return to work (RTW), which is based in cognitive behavioral theory, that has a primary aim of helping sick-listed patients with common mental illness return to work. This new treatment has not been evaluated in a randomized controlled trial. Aims: The aim of this study is to investigate the effect of CBT and RTW for common mental illness in a randomized controlled trial conducted in primary care. Participants will be randomized to diagnosis specific CBT (n=70), RTW (n=70), or a combination of the two treatments (n=70). Main outcomes are days of sick leave and clinician severity rating of psychiatric symptoms. This study could contribute to new knowledge regarding how to best treat patients on sick leave with common mental illness.
The objective of this study is to screen the effective core formulation in insomnia treatment with Chinese medicine with a double-blind, randomized, placebo-controlled trial.
Summary Introduction: Insomnia is a symptom of sleep disorders most prevalent. Primary insomnia, the investigators analyzed, often related to stress states acquired, generalized anxiety and stress, which are important factors that disrupt normal sleep. The investigators point out a fact that still intrigue the students of medicine and sleep that is distorted perception of sleep by the sleepless nights, polysomnography shows greater effectiveness than that perceived by them. On the other hand, there is evidence that mindfulness techniques may reduce symptoms of stress and anxiety as well as improve the general attention, which may contribute to a better perception of the effectiveness of sleep. In addition, there are studies showing that meditation is associated with metabolic and neurophysiological characteristics similar to normal sleep. Objectives: To compare sleepless menopausal women trained for 8 weeks in the technique of mindfulness insomniac postmenopausal untrained and also assess the quality of sleep experienced meditators menopausal comparing them to the group of healthy postmenopausal women untrained in the art.
This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to receive Neu-P11 20 mg, Neu-P11 50 mg or placebo for 4 weeks The objective of this study is to assess the efficacy of Neu-P11 (20 and 50mg) on sleep continuity parameters in insomnia patients aged 18-80 years, following the first two nights (immediate effect) and at the end of 4 weeks of double-blind treatment. The primary efficacy endpoint in this study is Latency to Persistent Sleep (LPS) measured by polysomnogram (PSG) at the first two nights of treatment (nights 15-16 of the study; mean of two consecutive nights recordings). The secondary endpoints are number of awakenings after sleep onset and the duration of wake after sleep onset measured by PSG at the first two nights of treatment (nights 15-16 of the study; mean of two consecutive nights recordings).
The purpose of this study is to determine if an herb called chamomile can help to treat insomnia (difficulty in going to sleep or getting enough sleep) by increasing the amount of time that you sleep and/or improving the quality of your sleep. The study will also be looking at the effect of chamomile on day time fatigue and functioning.