Insomnia Disorder

This study aims to apply traditional auricular press-needle acupuncture to treat sleep disturbances in elderly patients (aged ≥65 years) with comorbid diabetes mellitus and hypertension in rural areas of China. Given the complex bidirectional relationship between diabetes mellitus with hypertension and sleep disturbances, this cluster randomized trial is designed to test whether a village doctor-led intervention model supported by telemedicine can improve sleep disturbances in patients with comorbid diabetes mellitus and hypertension, compared to sham auricular press-needle acupuncture. Participants will be recruited by local village doctors according to the inclusion and exclusion criteria. The protocol is based on Traditional Chinese Medicine theory for core point selection: Heart, Liver, Kidney, Shenmen, and Forehead area, along with optimized medication regimens supported by remote cardiovascular specialists. The investigators will evaluate the overall improvement in sleep disturbances using the Pittsburgh Sleep Quality Index (PSQI) at the end of the 6-week treatment period, and assess sleep disturbances, anxiety, depression, daytime sleepiness, and fatigue at 12 weeks.

The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese adult participants with insomnia disorder.

DARIDOR-ALZ is a phase IV clinical trial designed to evaluate both the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist that blocks the actions of the orexin neuropeptides at both orexin-1 and orexin-2 receptors, in selected populations of MCI and mild-to-moderate AD patients with insomnia complaints.

The purpose of this study is to assess the relative effectiveness, safety, and durability of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC) (melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used prescription that may have a better risk/benefit profile (doxepin).

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effects of a virtual reality (VR) relaxation intervention among adults aged 25 to 50 with insomnia disorder. The main questions this study aims to address are: * Is a VR relaxation intervention feasible to implement and acceptable for individuals with insomnia? * Does the intervention reduce pre-sleep cognitive and somatic arousal? * Does the intervention improve sleep quality and sleep depth? * Can the intervention enhance overall sleep health and reduce symptoms of insomnia, anxiety, and depression? * Are these potential benefits maintained at a 3-month follow-up? Participants will be randomly assigned to either the intervention group or a waitlist control group. Researchers will compare outcomes between groups to evaluate the impact of the intervention. Participants will: * Complete online questionnaires at three time points (baseline, post-intervention, and 3-month follow-up) assessing sleep health, pre-sleep arousal, and symptoms of insomnia, anxiety, and depression * Take part in an in-person diagnostic interview at Université Laval to assess sleep and mental health status * Complete a daily online sleep diary for 8 weeks (2 weeks baseline, 4 weeks intervention, and 2 weeks post-intervention) * Engage in a 15-minute VR-guided meditation session each evening at home for 4 weeks * Wear a portable sleep monitor at home for 8 nights (4 nights baseline and 4 nights post-intervention) * Complete an acceptability questionnaire following the intervention

The goal of this clinical trial is to learn if inulin and spirulina, used alone or in combination, can improve insomnia disorder in adults aged 18 to 60 years with chronic insomnia disorder. It will also learn about the safety of these interventions. The main questions it aims to answer are: Does inulin plus spirulina improve sleep quality, as measured by the reduction rate in Pittsburgh Sleep Quality Index (PSQI) score? Does the intervention improve sleep-related, mood, anxiety, and cognitive outcomes after 12 weeks? Researchers will compare an inulin group, a spirulina group, a combined inulin plus spirulina group, and a placebo group to see if the combined intervention provides greater benefit than either single intervention or placebo. Participants will: be randomly assigned to 1 of 4 groups: inulin, spirulina, inulin plus spirulina, or placebo; take the assigned study product once daily for 12 weeks; complete sleep, mood, anxiety, and cognitive assessments at baseline and week 12; undergo polysomnography and provide blood and stool samples at baseline and week 12; and be monitored for adverse events throughout the study.

The primary purpose of this phase 3 study is to evaluate the safety and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) and wakefulness after sleep onset (WASO) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.

This two-arm randomized trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) to all participants and passive body heating (PBH) sessions using a sauna blanket to half of participants over a 9-week treatment period. Participants are adults aged 18 years or older with insomnia disorder.

This study will investigate treatments for insomnia in Veterans who have posttraumatic stress disorder (PTSD). The purpose of this study is to compare a brief behavioral treatment for insomnia (BBTI) to a treatment that helps promote relaxation (progressive muscle relaxation training or PMRT). The investigators will examine improvements in psychosocial functioning and insomnia severity. The investigators will also examine whether treatment gains last over time and whether suicidal ideation decreases following insomnia treatment.

In this clinical trial, the investigators test whether mental Imagery Rescripting (IR), a technique where the individual is instructed to transform a negative memory or image into a positive one, and olfactory Targeted Memory Reactivation (TMR), a technique used to strengthen memories, can reduce hyperarousal and insomnia severity in patients with Insomnia Disorder (ID). Patients with ID will be randomized into four groups: in the first group (SH group), patients will have 4 weekly sessions (1 session/week) of a minimal intervention for insomnia (sleep hygiene information) in the presence of an odorless diffuser, which will be also used during the night. In the second group (IR group), patients will use IR during wakefulness to induce a state of relaxation and positive emotionality. More specifically, during 4 weekly sessions of IR, patients will imagine a negative scenario related to their pre-sleep images or current concerns (e.g., social interactions, self-image, sleep problem, nightmares) and transform it into a positive script. They will then perform IR every day for 4 weeks at home in the presence of an odorless diffuser, which will be also used during the night. In the third group, patients will undergo the same 4 weekly IR sessions and an odor will be paired to the positive imagery and will be diffused during the night (TMR group). Patients from this group will also perform IR every day for 4 weeks at home. Finally, the fourth group (OA group) will receive 4 weekly sessions of sleep hygiene instructions in the presence of an odor, which will be also used during the night. Clinical evaluation of insomnia severity before and after the intervention will take place using the Insomnia Severity Index (ISI, primary outcome measure). At the end of these interventions, patients with persistent symptoms will benefit from an alternative experimental treatment ("rocking bed") in which they will be cradled for one night. The investigators hypothesize that patients treated with IR will have significantly reduced insomnia severity compared to participants who received a minimal intervention. They also hypothesize that patients of the TMR group, will have more reduced ID severity compared to participants performing IR and with an odorless diffuser, therefore without an association (IR group). Finally, they hypothesize that one night of sleeping in a rocking bed will improve objective measures of sleep in ID compared to a stationary condition.

The goal of this multicenter, double-blind, double-dummy, randomized controlled trial was to examine the efficacy and safety of Compound Ciwujia Granules in the treatment of chronic insomnia. A total of 1200 participants with chronic insomnia were randomly assigned to receive one of the three treatment for 4 consecutive weeks: Compound Ciwujia Granules + placebo of estazolam, estazolam + placebo of estazolam + placebo of Compound Ciwujia Granules, or Compound Ciwujia Granules + estazolam + placebo of estazolam. Outcomes were assessed at 2 weeks, 4 weeks, 8 weeks, and 12 weeks. The main questions it aims to answer are: 1. Are there any significant differences between groups regarding changes in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedative and hypnotics use, improvement in sleep maintenance, Hamilton Depression Scale (HAMD-17) score, Hamilton Anxiety Scale (HAMA-14) score, Flinders Fatigue Scale (FFS) score, and constitution classification/insomnia pattern score of traditional Chinese medicine after 4 weeks' treatment, and follow-up at 8 weeks and 12 weeks. 2. Is the Compound Ciwujia Granules a safe method for chronic insomnia treatment in adults?

The goal of this clinical trial is to explore the outcome and practice treatment for sleep-wake disturbances in a Sleep Clinic. The main questions it aims to answer are: * What is the practice (timing and duration of treatment components) of sleep-wake disturbance treatment? * What is the treatment effect of sleep-wake disturbance treatment. Participants will receive treatment as usual by consultations with a trained psychiatrist or psychologist and will be asked to fill out self-reporting questionnaires and sleep diaries.

The primary aims of this study is to contrast the effectiveness of CBT-I and pharmacotherapy (lemborexant) compared to placebo on sleep and mental health outcomes in people with insomnia disorder and anxiety/depressive symptoms. In addition, the study will evaluate whether insomnia phenotypes (i.e., +/- 6hrs of sleep) at baseline moderate the effectiveness of the intervention on both sleep and mental health outcomes.

This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule and habits. BRT is a simpler and shorter therapy focused on aligning the time spent in bed with reported sleep time. CBT-I includes additional components such as relaxation techniques and cognitive exercises. The study will compare these treatments to see if BRT is as effective as CBT-I in improving the clinical symptomatology of insomnia.

This study evaluates the effectiveness and safety of a digital Cognitive Behavioral Therapy program for Insomnia (CBT-I) in individuals with chronic insomnia. Participants will be randomly assigned to either begin digital CBT-I immediately or join a wait-list.

Insomnia and eating disorders are highly prevalent among adolescents, often co-occur, and are associated with somatic and mental comorbidities and functional impairment. The first aim of this project is to longitudinally monitor psychological functioning and sleep- and eating-related behaviours in a large sample of students aged 14-17 yrs. (N = 854), to identify the variables that predict transition from a prodromal phase to a clinical stage, and signpost individuals at risk or with clinical symptoms to self-help materials and clinical support. The second aim is to test whether increased emotional reactivity to disease-related stimuli (stimuli related to sleep or eating) in a virtual reality environment can discriminate between individuals at risk or with clinical symptoms and healthy peers. The third goal is to conduct a pilot randomized controlled trial to test a virtual reality self-help exposure-based intervention to remediate eating or sleep difficulties in individuals at risk or exhibiting clinical symptoms of eating disorders or insomnia.