Active clinical trials for "Sleep Initiation and Maintenance Disorders"

Objective: To investigate whether Fecal Microbiota Transplantation(FMT) can improve sleep in patients with insomnia, its effect on gut microbiota and its metabolites, and its effect on inflammatory factors, neurotransmitters and sex hormones in peripheral blood. Methods: The study needs to recruit 60 patients with insomnia and randomly divide them into FMT capsule treatment group or Placebo treatment group. The patients were followed up before the treatment and 4, 8, and 12 weeks after the treatment. The sleep status of the patients was assessed by Pittsburgh sleep quality index-PSQI, and the changes of gut microbiota and its metabolites were detected by Metagenomic sequencing and metabonomics analysis.The expression of cytokines, sex hormones and neurotransmitters in peripheral blood were detected by Elisa.

Adolescence is a critical transitional stage characterised by a cascade of developmental changes in biological, cognitive, and psychological functioning. Sleep problems, particularly insomnia, are prevalent in adolescents, with a prevalence rate as high as 36%. Insomnia symptoms, presented as the problems initiating sleep or maintaining sleep, have often been reported in association with adverse outcomes in adolescents, including an increased risk of developing depression, anxiety, interpersonal problems, somatic health problems, self-harm and suicidal ideation. This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in reducing insomnia severity in youth with insomnia.

This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.

The goal of this research is to establish a proof of concept for optimizing and evaluating a personalized SMS intervention based for individuals with chronic sleep problems.

The current study aims to evaluate the efficacy and feasibility of a digital application-based CBTi treatment devised for adults with ADHD and insomnia compared to self-monitoring and sleep hygiene control condition.

This study will evaluate neurofeedback (NFB) training as a low risk, non-invasive, effective treatment for Veterans diagnosed with mild traumatic brain injury (mTBI) and experiencing chronic post-concussive symptoms (PCSs). It is being funded by the Department of Veterans Affairs. Doing this study will help to determine if NFB will reduce chronic headaches and enhance sleep, attention and quality of life in Veterans with mTBI. NFB is like other biofeedback processes in which information about a person's specific body functioning is made known to the person through a special computer program, which can help that person make the specific body function work better through training. This type of training is usually fun and easy with the help of a coach and a computer. Nothing is ever put into a person's body with biofeedback and it is natural and safe. When a person becomes focused, calm and alert while training on an NFB system, the computer will recognize this and let the trainee know by automatically displaying on the computer screen the positive progression of the game they are playing, such as the plane moving forward or a flower opening. The brain really likes to be in this pattern and when it is happening, people feel good. As a result, any discomforts, like headaches or insomnia, experienced may decrease. After learning about the study, Veterans who agree to participate will be randomly placed into one of two groups, either an intervention group (who will receive NFB) or a control group (who will receive only usual care plus once a week 15-minute calls on health topics). Veterans will have an equal chance of being in either group. Those placed in the control, will also receive NFB after completion of the control group activities. Veterans who are placed in the intervention or delayed intervention group will receive NFB up to 5 times a week, but usually 3 times a week for a total of 20 sessions. Each session is an hour long. Both the intervention and control group will participate in four assessment sessions (lasting up to 2 1/2 hours each) that involve completing 12 questionnaires and a 20-minute attention evaluation. The assessment sessions will occur at the beginning of the study, at 4-6 weeks, at 8-10 weeks, and 2-months later. The participant will receive financial compensation for taking the baseline assessment, 4-6 week, 8-10-week assessments, and for the 2-month follow-up assessment. A participant will receive financial compensation for gas, time and valet parking for each intervention and assessment session. Participation in this research will last about 4 months for those in the intervention and 8 months for those in the delayed intervention group. All participants will receive the NFB treatment by the end of the study. A person who participates in this study may experience a reduction in his or her chronic headaches, and an enhancement of sleep, attention and quality of life. There may be a worsening of symptoms until the individualized training plan for a person can be identified. During an NFB session, brief moments, lasting only seconds or minutes, of dizziness while sitting, muscle tension, or tingling may be experienced. Most people feel relaxed and calm during and after NFB training. This project will be an important step towards a broader implementation of an evidence-based treatment solution for Veterans experiencing chronic headaches, insomnia and attention disorders. The experience of these chronic symptoms can lead to debilitation in all areas of Veterans' lives. This project will provide evidence for the use of NFB with Veterans to alleviate their chronic symptoms and enhance their quality of life. If supported, NFB will offer the investigators' Veterans an effective and non-invasive treatment option. NFB is a patient focused intervention that enables Veterans the opportunity for self-health management.

Sleep problems are pervasive in people with schizophrenia. In our study, our goal is to determine whether we can alleviate sleep symptoms and improve quality of life and well-being in patients with major psychiatric disorders through cognitive behavioral therapy (CBT) delivered via the internet or in groups. At the same time, the study provides information on factors that are commonly associated with sleep and well-being in patients. The intervention study is conducted as a Randomized Controlled Clinical Trial (RCT), in which subjects are randomized into three groups: 1) Treatment as usual (TAU), 2) TAU and Internet-based therapy for insomnia (ICBT-I), and 3) TAU and group therapy for insomnia (GCBT-I).

Assess the effect of a customized audio track delivered via standard commercially-available bone conduction headsets on the quality of sleep

Insomnia disorder (ID) is a significant public health problem worldwide, with nearly a third of the general population experiencing insomnia symptoms in their lifetime. Therefore, finding a safe, effective, and easy-to-use non-pharmacological method for treating ID is urgent. Repetitive transcranial magnetic stimulation (rTMS) has been used to varying degrees in many neurological and psychiatric diseases and has broad application prospects for treating ID.θ-burst stimulation is characterized by cluster stimulation.Continuous stimulation (cTBS) mainly has inhibitory effects on the cortex. The inhibition of motor-evoked potentials can last for 60 minutes, which is longer-lasting, has a lower stimulation intensity, and is shorter in duration than traditional rTMS. There are no reports on clinical studies of cTBS treatment for ID. So far, sleep research has mainly focused on the interconnections between the neocortex and subcortical structures, while cerebellar activity has been largely overlooked.The mechanism of rTMS treatment for insomnia with the cerebellum as the target is unclear. This study proposes to apply cTBS mode to the cerebellar dentate nucleus for rTMS treatment in patients with ID to explore its effectiveness and safety in improving insomnia disorder.

The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).