Active clinical trials for "Sleep Initiation and Maintenance Disorders"

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.

This study will build upon a previously approved protocol entitled "A multi-center prospective, blinded, randomized crossover study to compare the Cerêve Sleep System at two different temperatures in primary insomnia patients" (CIP-003; CER1-01-090). In that study, 150 insomnia patients were targeted to be randomized to complete in lab assessments of sleep using the Cerêve Sleep System. In this follow-on study, 36 patients who completed the in lab study will be enrolled to complete 2 phases of in home use of the device. In the first phase, the durability study, 30 patients are targeted to complete additional in lab assessments following 30 days of in home use of the device. In the second phase, the home use pattern study, 24 patients are targeted to complete an additional 5 months of in home use in which their use patterns will be monitored. Hypothesis: EEG sleep latency and sleep efficiency following 30 days in home use of the device at 14-16°C will be similar to those measures after the initial acute, 2-night use in the parent study in the 14-16°C condition. The device will demonstrate a benign safety profile over 6 months in home use.

This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.

The purpose of this study is to determine whether the addition of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) to usual care will improve insomnia symptoms based on changes in the Insomnia Severity Index at two months following completion of the intervention, compared to placebo plus usual care.

The purpose of this study is to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT).

The purpose of the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to persistent sleep) in participants with major depressive disorder who are stably treated with selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor who suffer from insomnia (inability to fall asleep).

KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy to improve sleep quality in over 55 years old primary insomnia patients. This is a 2nd bridging study to investigate the efficacy and safety of KI1001(Circadin®) in Korean patients.

More than half of patients with Parkinson's have troubles with insomnia. There are several treatment options for insomnia that have been studied in the general population - however, the investigators don't know if these treatments work for patients with Parkinson's. It is possible that people with Parkinson's may have different treatment responses. The goal of this project is to test in a pilot study the tolerability and effectiveness of pharmacologic and non-pharmacologic treatments to improve insomnia in patients with Parkinson's disease. Each participant in this study will be wearing a wrist actigrapch and fill out the sleep diary. Three main treatment strategies will be tested: Placebo Light therapy, Cognitive behavioural therapy and active light therapy, and insomnia medications. The treatment that each person will receive first will be chosen randomly. If the first therapy has not been effective, participant may choose to re-enrol in the trial with one of the remaining two therapies.

This study includes two sub-trials. In trial 1 patients suffering from insomnia but not meeting the criteria for depression are randomised to either therapist guided Internet-based CBT for insomnia or to a control group with a non-guided, brief self-help program that acts as a placebo control. The primary purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive effect on future depressive episodes. Recruitment is done through mass media and includes all regions of Sweden. Initial assessment based on questionnaires and telephone interviews. Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each respective treatment's effect on both insomnia and depression. The patients need for further treatment after the initial one will be measured and used as a secondary outcome. Recruitment is done through mass media but only citizens in the Stockholm area are included since the initial assessment are based on both questionnaires and telephone interviews as well as a visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm. Both trials will include health economic data and analysis. For the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.

The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.