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Insomnia clinical trials

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NCT ID: NCT06443242 Not yet recruiting - Clinical trials for Major Depressive Disorder

Efficacy and Safety of Low-dose Laser Acupuncture on Treating Insomnia Associated With Major Depressive Disorder

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to assess the efficacy and safety of low-dose laser acupuncture (LLA) in alleviating insomnia symptoms among patients suffering from major depressive disorder. The study seeks to answer the following questions: 1. How effective is LLA in alleviating insomnia symptoms as compare with SLA and control subjects among patients with major depressive disorder across pre-treatment, mid-treatment and post-treatment assessment? 2. What role do CORT and 5-HT play in the co-occurrence and progression of insomnia and major depressive disorder, and how does LLA act on these mechanisms to provide relief? 3. Does LLA enhance the effectiveness of pharmacological interventions in treating insomnia and major depressive disorder when used as an adjunctive treatment? 4. How does the safety and acceptability of LLA compare to traditional acupuncture in terms of eliminating discomfort and potential side effects? Researchers will compare the effects of LLA with sham laser acupuncture (SLA) and standard medication treatments to evaluate its efficacy and safety. Participants involved in this study will: Undergo 30 treatment sessions with LLA or SLA, five times a week for six weeks. Continue their usual pharmacological treatments for major depressive disorder. Participants will undergo comprehensive assessments at key points: pre-treatment, immediately post-treatment, and 12 weeks post-treatment. These evaluations will measure sleep quality indices, levels of depression and anxiety, and blood levels of CORT and 5-HT to assess the impact of LLA on insomnia symptoms and biochemical markers. Additionally, participant acceptance and the safety of the treatment will be monitored, including recording any adverse events and medication usage, to determine the effectiveness and safety of LLA in treating insomnia associated with major depressive disorder. By focusing on these elements, the study aims to provide clear, actionable insights into the benefits and risks of LLA as a treatment option for insomnia associated with major depressive disorder, enhancing the current treatment landscape and patient outcomes.

NCT ID: NCT06435520 Not yet recruiting - Insomnia Clinical Trials

Enhancing Hypnotic Medication Discontinuation in Primary Care

Start date: September 1, 2024
Phase: Phase 4
Study type: Interventional

Many individuals with insomnia seek treatment in primary care settings, where they often receive prescription hypnotic medications as their first and sometimes only treatment. However, extended use of these medications can lead to reliance and increased health risks, such as falls and cognitive impairments. While evidence-based approaches like physician-supervised medication tapering exist, they're not widely available in primary care. Most primary care providers are willing to explore non-drug treatments like cognitive behavioral therapy for insomnia (CBTI), but accessing such treatments can be challenging outside of specialized sleep centers. This gap between research and practice underscores the need for cost-effective interventions to manage insomnia and help patients reduce their reliance on hypnotics in primary care. In response to this need, the project aims to conduct a large randomized trial comparing a combined digital CBT (dCBTI) and medication tapering intervention with medication tapering alone. We'll recruit 430 patients reliant on hypnotics from 8-10 primary care clinics affiliated with the University of Colorado Medical School. The main goal is to assess the effectiveness of dCBTI+SMT compared to SMT alone in reducing hypnotic use and improving insomnia symptoms. Additionally, we'll evaluate factors affecting the adoption and implementation of these interventions at the patient, provider, and system levels. This information will inform future implementation strategies to disseminate effective treatments in primary care. Furthermore, we'll gather data to identify which patients benefit most from dCBTI+SMT. Overall, this study will provide valuable insights into the feasibility, clinical utility, and acceptability of these interventions in managing insomnia and reducing reliance on hypnotic medications in primary care. Ultimately, this project represents a crucial first step toward making accessible and cost-effective strategies available to improve the quality of life for millions of chronic users of sleep aids.

NCT ID: NCT06434571 Not yet recruiting - Multiple Sclerosis Clinical Trials

Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection

CLEAR
Start date: August 1, 2024
Phase: Phase 2
Study type: Interventional

The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.

NCT ID: NCT06430333 Not yet recruiting - Depression Clinical Trials

Sleep to Reduce Incident Depression Effectively in Peripartum

STRIDE P
Start date: October 1, 2025
Phase: N/A
Study type: Interventional

Perinatal depression (PND) is the most common complication in pregnancy and postpartum, which increases risk for adverse perinatal outcomes such as preterm birth, maternal suicidal thoughts, and impaired mother-infant bonding. Insomnia often precedes PND cases and may serve as an entry point for interventions preventing PND. The proposed project is a large-scale clinical trial to test the effectiveness of a mindfulness-based sleep program designed for pregnant women to improve sleep and alleviate cognitive arousal to reduce risk for PND across pregnancy and postpartum.

NCT ID: NCT06428006 Not yet recruiting - Multiple Sclerosis Clinical Trials

Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis

CALM
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).

NCT ID: NCT06407258 Not yet recruiting - Insomnia Clinical Trials

Promoting Sleep and Physical Activity Among Adolescent Psychiatric Patients

SLEEPAC
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Mental health disorders pose a significant burden on adolescent populations globally, often accompanied by sleep disturbances. Emerging evidence suggests that addressing sleep issues can improve mental health outcomes, while physical activity is increasingly recognized as beneficial for both sleep and mental well-being. This study aims to assess the effectiveness of a novel intervention (SLEEPAC), combining cognitive-behavioral therapy for insomnia (CBT-I), circadian treatment, and PA counseling, compared to treatment as usual (TAU), in improving psychopathology among adolescent psychiatric outpatients with sleep disturbances. Secondary outcomes include improvements in sleep health, physical activity levels, cognitive performance and self-esteem. Additionally, the study seeks to explore the predictive value of sleep neurophysiological biomarkers using high-density sleep electroencephalography (EEG), contributing to advancements in precision psychiatry for this population.

NCT ID: NCT06403969 Not yet recruiting - Insomnia Clinical Trials

Sleep in Children With Autism and Intellectual Disability

SLEEP-AID IT
Start date: May 14, 2024
Phase: N/A
Study type: Interventional

Purposes: Establish proof-of-concept for home polysomnography in the assessment of sleep disorders among prepubertal school children with autism and intellectual disabilities combined; To explore the diagnostic yield of polysomnography for these individuals; To examine the feasibility and treatment effect of Applied Behavior Analysis (ABA) for insomnia, focusing on sleep maintenance difficulties, in these children. Method: Single-case experimental design with multiple baselines and with multiple participants, with a focus on feasibility. N=15 prepubertal children, aged 6-12 years, with autism and intellectual disabilities combined, and difficulties in maintaining nighttime sleep. Assessment with home polysomnography + actigraphy. Intervention with ABA, including functional analysis, measurable goals, and behavior modification based on the functional analysis. Outcome measures from actigraphy and sleep diary with multiple data points at baseline and after treatment. Feasibility is examined as adherence to assessment and treatment, as well as in a qualitative study of parental experiences.

NCT ID: NCT06379074 Not yet recruiting - Stress Clinical Trials

Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health

MOTHERS
Start date: May 6, 2024
Phase: N/A
Study type: Interventional

Improving maternal mental health is a worldwide health priority. Nevertheless, several scientific sources highlighted lack of empirical data which could drive clinical practice. The present project addresses psychobiological mechanisms leading to peripartum mental disorders. It focuses on one key risk factor for psychopathology, which is poor sleep continuity. The project aims to describe the link between maternal poor sleep quality and the cascade of events which may enhance vulnerability to stress and risk for mental disorders and to evaluate the efficacy of an online automated psychological prenatal intervention directed to sleep problems in preventing these negative outcomes.

NCT ID: NCT06378554 Not yet recruiting - Depression Clinical Trials

Cereset Research for Performance Improvement in a Hospital Nursing Unit

Start date: June 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to explore whether an implementation process composed of offering CR to staff in a single hospital nursing unit has any potential impact on unit-level quality measures post-implementation.

NCT ID: NCT06376760 Not yet recruiting - Insomnia Clinical Trials

Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy

Start date: April 15, 2024
Phase:
Study type: Observational

To compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern.