Active clinical trials for "Sleep Initiation and Maintenance Disorders"

The trial aims to evaluate the effectiveness of a novel digital health application (somnovia), which was designed to increase sleep quality in persons with insomnia disorder. Therefore, 290 people with insomnia disorder will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment for insomnia disorder and are offered access to somnovia after a delay of 6 months (i.e., Care-as-Usual [CAU]), or (2) to a treatment group that immediately receives 6-month access to somnovia and may also use CAU. The primary outcome measure is the score of the Insomnia Severity Index (ISI), collected at three months post-baseline.

The purpose of the study was to determine safety and efficacy of WELT-IP in adult insomnia patients. WELT-IP is a cognitive behavioral therapy for insomnia (CBT-I) based digital therapeutics.

This study aims to investigate the effectiveness of transdiagnostic nurse-administered 4-session group cognitive behavioral therapy for insomnia (CBT-I) plus standard care, compared to standard care alone, for improving sleep and daytime function, enhancing recovery, preventing relapses, and reducing medication burden in patients with the first episode of mood disorders.

The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.

The therapeutic options are limited in Parkinson's Disease (PD) patients with insomnia and are often based on pharmacological treatments. It has been shown that the cognitive behavioral therapy can be effective in primary insomnia. To the investigators knowledge, the effect of computerized cognitive behavioural therapy on insomnia in PD has not been evaluated before. The aim of this study is to demonstrate the beneficial effects of 6-weeks of computerized cognitive behavioural therapy on clinical and sleep variables of insomnia in Parkinson's disease patients.

The current study seeks to evaluate cognitive behavior therapy for insomnia (CBT-I), a non-medication treatment, in recent TBI patients compared to a sleep education control intervention. Patients will participate in CBT-I treatment (or sleep education treatment) weekly for six weeks, and will have a 3-months follow-up visit in order to examine the efficacy and time course of treatment. In addition, participants will complete several self-report questionnaires in order to examine sleep and neuropsychiatric symptoms throughout treatment.

The purpose of this study is to directly compare the effectiveness of two interventions for insomnia: Brief Behavioral Treatment for Insomnia (BBTI) vs. Cognitive Behavioral Therapy for Insomnia (CBTI).

The purpose of this study is to investigate exploratorily the effect of ramelteon 8 mg once daily for 8 weeks in the treatment of insomnia patients with depression by using actigraphy.

Participants (N=47) are patients with major depression. Participants are assessed with clinical interview, polysomnographic evaluation and screening with Insomnia Severity Index (ISI), Dysfunctional Beliefs About Sleep-scale (DBAS), HDRS, MINI and Sleep Diary pre and post treatment. Participants are randomly assigned to either treatment as usual or CBT-I. The latter receives individual as well as group therapy with CBT-I during 6 sessions. Post-treatment: The investigators will compare changes in sleep diary parameters, HamD17, ISI and DBAS. Data are analyzed by using Chi-square test, Wilcoxon-Mann-Whitney U-test and ANOVA. STATA is used for data-processing.

Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are independently linked to reduced quality of life, disability, and high healthcare costs. Insomnia, characterized by difficulty initiating or maintaining sleep, or nonrestorative sleep, is prevalent in 10% of the general population and is co-morbid in 70% of patients with SUDs. Primary insomnia and SUDs are chronic, unremitting diseases and have a complex bidirectional relationship. Insomnia symptoms may predate the onset of SUDs and may explain high prevalence of self-treatment. Insomnia may also be a direct effect of intoxication, withdrawal, or abstinence from the substance of abuse. Subjective and objective measures of sleep disruption have been shown in various stages of abuse and recovery. Insomnia is the most well documented predictor of substance use relapse. Treatment specifically targeting chronic insomnia is essential for improved clinical outcomes. Although, chronic insomnia is a well-established, modifiable risk factor, to our knowledge, there are no interdisciplinary residential treatment programs that specifically treat chronic insomnia during acute SUDs treatment. We propose that improved treatment of insomnia as part of a comprehensive reinforcement-based outpatient treatment program will provide an efficient and cost effective opportunity to improve standard outpatient SUD. Converging evidence suggests that prophylactic CBT-I during SUD treatment may have short and long-term efficacy for sleep, and improve attrition. In the proposed study, patients with co-morbid SUDs and insomnia will engage in an 8-week group CBT-I (gCBT-I) program in addition to receiving treatment as usual for SUDs. This study may provide new hope to effectively treat insomnia in SUD and lead to a new standardization of outpatient care. We hypothesize that a CBT-I intervention can be implemented as part of an evidence-based SUD treatment program within a residential facility.