Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 474 trials
NCT06843187
The goal of this clinical trial is to learn if Lemborexant works to treat residual insomnia in adults with depression that is being treated. It will also learn about how practical, tolerable, and effective Lemborexant is. The main questions it aims to answer are: * Does Lemborexant help participants improve sleep and reduce insomnia symptoms? * How practical is it to use Lemborexant (how many participants join, drop out, and follow the study rules)? How do participants feel about using it (based on surveys and interviews)? Researchers will compare Lemborexant to a placebo (a look-alike substance that contains no drug) to see if Lemborexant works to treat residual insomnia in adequately treated major depressive disorder. Participants will: * Take Lemborexant or a placebo every day for 6 weeks (2 weeks at 5 mg then 4 weeks at 10 mg) * Complete clinical assessments and in-person study visits * Maintain a digital sleep diary and complete daily and weekly self-report ecological momentary assessments (EMAs) * Use a wearable device which will be used to collect and monitor physiological data
NCT04896775
The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.
NCT07552714
Non-organic insomnia is a prevalent disorder that significantly impairs quality of life, characterized by difficulty initiating or maintaining sleep alongside daytime functional decline. This condition is particularly common among adults facing chronic stress, which increases the risk of chronic diseases and dysregulates the Microbiota-Gut-Brain Axis (MGBA)-a bidirectional communication system between the central nervous system and the gut microbiota. Prolonged sleep deprivation and stress can trigger inflammatory responses and gut dysbiosis, which in turn exacerbate emotional and sleep disturbances. While conventional sedative-hypnotics often carry side effects and risks of dependency, traditional medicine interventions are emerging as potential sustainable solutions. This study evaluates the efficacy of thread embedding combined with auricular acupressure based on individualized traditional Chinese medicine syndrome differentiation, while clarifying the relationship between clinical sleep improvement and changes in MGBA-related inflammatory markers, specifically interleukin-6 and calprotectin. The goal of this clinical trial is to evaluate the clinical efficacy and preliminarily investigate the mechanisms of action-via the Microbiota-Gut-Brain Axis-of individualized Traditional Chinese Medicine (targeting Heart-Spleen Deficiency and Liver Qi Stagnation syndromes) using thread embedding acupuncture combined with auricular acupressure to improve sleep quality in patients with insomnia, compared to a non-individualized protocol. The main questions it aims to answer are: * Does the combined method of thread embedding acupuncture and auricular acupressure based on syndrome differentiation improve sleep quality more effectively than the standardized protocol? * Is there a significant difference in the change of IL-6 and Calprotectin levels following treatment in the intervention group compared to the control group? * Does post-treatment clinical improvement correlate with the reduction of these inflammatory markers? Participants will: * Receive thread embedding acupuncture sessions every 4 weeks and have ear seeds (auricular acupressure) replaced every 2 weeks . Self-massage the ear seeds for 1 to 2 minutes several times each day, especially before bedtime. * Complete assessments of sleep quality (PSQI, ISI) and digestive health (GSRS) every 2 weeks through week 8. * Provide blood and stool samples at the start and end of the study to measure inflammation markers. * Be monitored for any adverse effects, such as local pain, dizziness, or needle fainting, during the trial period.
NCT07191119
This pilot study will assess the usefulness and potential effectiveness of using transcutaneous auricular vagus nerve stimulation (tVNS) for treating insomnia in adult survivors of childhood acute lymphoblastic leukemia (ALL). Participants will be randomized to receive either active (verum) or inactive (sham) nightly stimulation using a non-invasive earbud device over two time periods: 2 weeks and 8 weeks. The study will assess adherence to the intervention and estimate its effects on sleep quality, stress, and neurocognitive function. Primary Objective: Aim 1: To determine a) short-term and b) long-term feasibility of tVNS in terms of participation in ALL Survivors with moderate to severe insomnia. Aim 2: To estimate the effect size of tVNS on sleep quality, stress, and neurocognitive outcomes in ALL survivors with insomnia. Exploratory Objectives Aim 1: To investigate the onset of tVNS effect via actigraphy measures over the intervention epoch. Aim 2: To estimate the effect size of genetic variants on sleep quality within verum tVNS.
NCT07547423
The goal of this clinical trial is to learn if auricular laser acupuncture can improve sleep quality and alleviate related symptoms in female breast cancer patients aged 18 to 75 with insomnia. The main questions it aims to answer are: 1. Does active auricular laser acupuncture improve sleep quality and reduce the severity of insomnia? 2. Does it help lower levels of cancer-related fatigue, anxiety, and depression? Researchers will compare an active auricular laser acupuncture group to a sham control group (receiving no therapeutic laser energy) to see if active laser acupuncture is effective for symptom relief. Participants will: 1. Receive 10 sessions of laser treatment (active or sham) twice a week for 5 weeks, while wearing protective goggles to ensure blinding. 2. Wear an actigraphy wristband and keep a sleep diary to monitor sleep patterns, and undergo heart rate variability (HRV) measurements at baseline and Week 5 (post-treatment). 3. Complete questionnaires assessing sleep, fatigue, mood, and quality of life at baseline, Week 5 (post-treatment), and Week 10 (follow-up).
NCT07547501
The objective of this study is to develop and validate deep learning algorithms for automated sleep stage and sub-stage classification using overnight polysomnography data. The models will be trained and evaluated on at least three independent datasets to ensure generalizability. \- Primary Outcome Measure : Accuracy of deep learning-based sleep stage classification compared to expert manual scoring (\>80% target agreement), evaluated across multiple polysomnography datasets including AP-HP (Assistance Publique - Hôpitaux de Paris) data. This is a retrospective, observational study.
NCT05780177
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.
NCT07542756
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).
NCT06373718
This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target.
NCT04700098
This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia versus online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.
NCT04458194
This feasibility phase II randomized controlled trial examines the preliminary efficacy of our standardized four-week YOCAS©® (Yoga for Cancer Survivors) intervention that is delivered virtually on insomnia and sleep quality in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. The vast majority of patients with cancer experience some form of sleep impairment post-treatment. Yoga is safe, feasible, and effective for improving insomnia and sleep quality in cancer survivors. However, most of the yoga intervention was delivered in person. With the challenges and the social distancing regulation regarding the COVID-19 pandemic, adapting to virtual behavioral intervention is critically important and needed. Whether the yoga intervention delivered virtually to survivors provides a similar benefit of improving insomnia and sleep quality is unknown.
NCT05516277
This pilot pre-post trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.
NCT05393830
The study is designed to investigate the impact of three nights of sleep restricted to 4 hours per night, on the processing and regulation of emotional information compared to Insomnia Disorder and control. The investigators will address and attempt to answer two questions. (i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the processing and regulation of emotional information compared to typical, undisturbed sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated with behavioral effects when attempting to process and regulate emotions in a sleep restricted state or with a clinical diagnosis of Insomnia Disorder? This study will investigate sleep's role in emotion processing and regulation. The findings will help further understanding of the role of sleep in healthy emotional functioning.
NCT05935241
Although empirical research suggests that physical activity interventions benefit cognition and sleep in older adults in general, the possible benefit of physical activity is understudied in low-income older adults. The study aims to test the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on cognitive function and sleep in low-income older adults.
NCT06827626
The goal of this clinical trial is to evaluate the usefulness of cognitive behavioural therapy for insomnia (CBT-I) tailored to shift workers in the social and health care sector. The study will also learn about the shift workers' experiences of the acceptability and feasibility of CBT-I and investigate which features of shift work and individual characteristics promote or interfere with the effectiveness of the tailored CBT-I. The main question the study aims to answer is: • Does CBT-I tailored to shift workers in the social and health care sector improve perceived insomnia severity, insomnia symptoms, mental health and quality of life? Researchers will compare CBT-I to a control intervention (short sleep hygiene counselling) to see if CBT-I works to treat insomnia in shift workers. Participants will: * Participate in the research intervention (CBT-I tailored to the shift work context; six individual sessions) or the control intervention (sleep hygiene counselling; one individual session) * Complete the measures (sleep diary, actigraphy and questionnaires) at baseline, after the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
NCT07384429
The aim of this study is to explore the effects of the dual orexin receptor antagonist Lemborexant on improving motor and sleep comorbidity in patients with Parkinson's disease. This study will provide clinical evidence for the application of dual orexin receptor antagonists in the treatment of Parkinson's Disease.
NCT06706453
Background This is a survey to understand sleep in the context of medical trainees (on call) and the participants knowledge about the relevance of sleep, shiftwork, and the impact that sleep may have on their working performance. The survey has been developed by sleep experts from America, Europe, and Africa, in collaboration with the World Sleep Society. It should take about 30-40 minutes to complete. The survey will focus on three different aspects, complemented by two standard questionnaires: 1. Demographics and Place of Work 2. Basic Knowledge and Perception of Sleep 3. Sleep Routine 4. Epworth Sleepiness Scale, Insomnia Sleep Inventory
NCT07481903
This clinical trial aims to assess whether electroacupuncture (EA) can alleviate the psychoneurological symptom cluster (including pain, fatigue, insomnia, anxiety, depression and subjective cognitive decline) in breast cancer survivors, and to evaluate the safety of this therapy. Researchers will conduct a randomized controlled trial of electroacupuncture (EA) as compared to sham electroacupuncture (SA) in breast cancer survivors with the psychoneurological symptom cluster who are currently being treated with endocrine therapy. Participants will receive 16 treatments over 8 weeks. The EA group will receive true acupuncture with continuous wave stimulation (2Hz, intensity as tolerated) administered for 30 minutes per session. The SA group will receive sham acupuncture using blunt (non-penetrating) needles that contact the skin without penetration, along with a 30-second transient device activation instead of the 30-minute continuous stimulation. Treatment outcomes for pain, fatigue, insomnia, anxiety, depression and subjective cognitive function will be assessed. The primary outcome is response rate of the psychoneurological symptom cluster after 8 weeks of treatment. Secondary outcomes include changes from baseline in the scores of each of the six psychoneurological symptoms.
NCT06910423
This study aims to compare the efficacy of the Mahayana Buddhist Awareness Training Program (ATP) with a Qigong group in treating people with insomnia in Hong Kong. It also aims to investigate the underlying mechanisms, including changes in brain activity and heart rate variability during wakefulness, through which these two Eastern mind body interventions improve sleep quality. It is expected that ATP will be as efficacious as Qigong in enhancing sleep quality. Compared to the Qigong intervention, the more mind-based ATP will lead to more improvement in mental health and greater reductions in hyperarousal brain activity. Compared to ATP, the more body-based Qigong will lead to greater improvement in physical health and heart rate variability.
NCT07430878
The objective of the study is to develop an algorithm to detect insomnia and classify its severity, based on data collected during the use of Withings products and from questionnaires sent to users