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Showing 1-17 of 17 trials
NCT07418554
Among the most sensitive and persistent symptoms of post-traumatic stress disorder (PTSD) in children are sleep disturbances in the insomnia spectrum (sleep onset disturbances, fragmented sleep with multiple nocturnal awakening, early morning awakening) as well as nightmares, affecting over 50% of children and adolescents one year after the initial trauma. There are currently no gold standard treatments or pharmacological treatment recommendations specifically for these sleep disturbances in children and adolescents with PTSD, despite the fact that they have a significant effect on daytime functioning and overall mental health of the children and their families. If not treated appropriately, these sleep disturbances in children and adolescents persist over time, and further increase anxiety in children. Sleep disturbances associated with PTSD are predictive of the persistence and long-term outcome of PTSD itself and associated depressive symptomatology, and of a decreased response rate to cognitive-behavioral psychotherapy for PTSD. We have previously shown in an international multicenter study that pediatric prolonged release melatonin (PedPRM) has high beneficial effects on sleep disturbances of the insomnia spectrum in children ages 2-17.5 years with autism spectrum disorder, and consecutive positive effects on children's daytime behavior, including anxiety and depressive symptomatology. Its benefit-risk ratio has proven to be excellent over a 2-year follow-up. Beyond its therapeutic benefit on mental health through improvement of sleep, melatonin may have a direct effect on reducing anxiety levels and overall daytime functioning in children, as well as sleep and daytime function in caregivers. Our study will be the first randomized controlled trial investigating the efficacy of prolonged release melatonin on sleep disturbances in children and adolescents with PTSD, as well as on PTSD symptoms, associated daytime function and overall mental health in these children and their caregivers.
NCT05212298
This project is planned to collect non-dialysis adults who suffer from sleep and tinnitus disorders and refuse to take sleeping medicines in our hospital by random assignment and double-blind method. 120 adults were divided into 3 groups. 1. Control group: receive placebo treatment, once a day, four pills each time. 2. Herbal compound low-dose group: once a day, two herbal compound capsules and two placebos each time. The total amount of herbal compound capsules is 582 mg. 3. Herbal compound high-dose group: once a day, four capsules each time. The total amount of herbal compound capsules is 1164 mg. All subjects received health questionnaire, sleep questionnaire and tinnitus questionnaire before the start of the test At the end of the treatment(3 months), the health questionnaire, sleep questionnaire, and tinnitus questionnaire were accepted.
NCT06844981
The primary objective is to assess the feasibility, acceptability and explore the impact of a culturally appropriate Latin Dance intervention vs. Usual Care on sleep quality for Hispanic cancer survivors. Secondary objectives are to examine the preliminary efficacy of a culturally appropriate Latin Dance intervention on secondary cancer- and treatment-related side effects (e.g., Quality of Life, distress, insomnia, fatigue).
NCT07298876
Background: Sleep disturbances, as a common symptom, can jeopardize the brain health and cognitive function and even lead to cognitive impairments in older adults. The co-occurring sleep disturbances cognitive complaints can significantly affect brain functions, and even be implicated as a key contributing factor in the development of prodromal Alzheimer's disease (AD). At present, very few non-pharmacological therapies are developed for managing these comorbidities in older adults. Focused low-intensity transcranial ultrasound stimulation (TUS) enables to stimulation the deep brain structures, such as hippocampus, with optimized focality and specific frequency. Objectives: 1) To investigate the safety, feasibility and efficacy of a 2-week focused low-intensity hippocampal TUS on the severity of sleep disturbances and cognitive impairments in elderly patients; 2) to determine the sample size of a full-scale randomized clinical trial of low-intensity TUS in patients with preclinical AD; 3) to evaluate the effects of low-intensity TUS on the severity of sleep quality and cognitive functions at 2, 6 and 10 weeks after the treatments. Design: A 2-week randomized, double-blind, controlled clinical trial. Methods: Chinese right-handed preclinical AD patients with sleep disturbances (aged from 60 to 90 years) will be randomly assigned to a 2-week intervention of either low intensity TUS or sham TUS, with 10 participants per arm. Before intervention, T1-weighted magnetic resonance imaging (MRI) data is used to construct individual realistic head model. Comprehensive assessments, including sleep quality, cognitive performance and plasma p-tau217, Aß42 and Aß40 will be conducted at baseline, 2nd week, 6th week and 10th week. Program adherence and adverse effects will be monitored throughout intervention.
NCT07224295
The goal of this clinical trial is to asses the effect of non invasive stellate ganglion disrupting on sleep distyrbances on postmenopausal female . The primary hypothesis: There is no effect of noninvasive stellate ganglion disrupting on sleep disturbance parameters of postmenopausal women. There is no effect of noninvasive stellate ganglion disrupting on quality of female's life Non invasive stellate ganglion disrupting with physical modality TENS will be applied on participants of study group. The participants will be screened for estradiol level and assed for the quality of sleep by specialized questionnaire.
NCT07198477
This cross-sectional study investigates the relationship between serum magnesium levels and the presence of sleep disturbances among patients with major depressive disorder (MDD).
NCT07179172
The research team proposes a multi-year study with the first year focusing on the developmental phase. In this initial phase, we aim to recruit 40 participants (including healthcare staff and older adults) from Shuang-Ho Hospital and the surrounding community to undergo two mindfulness intervention sessions, each lasting four months. We anticipate that these interventions will prevent and alleviate stress and depressive symptoms while enhancing self-awareness and psychological health.
NCT07178496
This study investigates the effectiveness of a combined intervention that integrates sleep hygiene education with physiotherapy exercises in patients suffering from chronic neck pain. Chronic neck pain is often associated with both musculoskeletal dysfunction and secondary sleep disturbances, which in turn may exacerbate pain perception, fatigue, and disability. Traditional physiotherapy exercise programs focus primarily on improving cervical mobility, muscle strength, and postural control, but they do not typically address sleep-related problems that can hinder recovery. The intervention in this study consists of two main components: Physiotherapy Exercise Program - A structured regimen targeting cervical spine mobility, deep cervical flexor strengthening, scapular stabilization, and postural correction. These exercises aim to reduce pain, restore function, and improve overall physical performance. Sleep Hygiene Education - A structured educational module covering principles of healthy sleep habits, including maintaining consistent sleep-wake schedules, creating an optimal sleep environment, limiting stimulants before bedtime, and adopting relaxation strategies to promote better sleep initiation and maintenance. By combining these approaches, the intervention addresses not only the physical impairments associated with chronic neck pain but also the psychosocial and behavioral factors contributing to poor sleep quality. Outcome Measures: Primary Outcomes: Sleep quality, assessed using validated tools such as the Pittsburgh Sleep Quality Index (PSQI). Secondary Outcomes: Disability and functional limitations, measured by the Neck Disability Index (NDI), along with pain intensity assessed using a Visual Analog Scale (VAS). Fatigue will be assessed by fatigue inventory index Study Hypothesis: The combined intervention of sleep hygiene education and physiotherapy exercise will lead to greater improvements in sleep quality and reductions in disability and fatigue compared to physiotherapy exercise alone. Clinical Significance: If effective, this integrative approach may provide a cost-effective, non-pharmacological management strategy for patients with chronic neck pain, targeting both physical and behavioral contributors to their condition.
NCT06685965
Post-traumatic stress disorder (PTSD) affects many people who have experienced traumatic events. A common issue with PTSD is severe sleep disturbances, such as nightmares. Current treatments often do not provide sufficient relief, especially for sleep problems. This study aims to determine whether dexmedetomidine - a medication already used in intensive care - can improve sleep quality in PTSD patients.
NCT07122921
Sleep disturbances are prevalent among children with chronic illnesses, yet the specific impact of cancer on sleep remains underexplored. This prospective and cross-sectional study aims to evaluate the prevalence, severity, and characteristics of sleep disturbances in Chinese children with cancer compared to healthy peers and children with other chronic diseases. By leveraging validated sleep assessment tools and parental reports, the goal is to identify unique challenges faced by children with cancer. Results might influence the design of personalized interventions aimed at enhancing the overall well-being of children with cancer. This study will enroll Chinese children aged 6 to 18 years, divided into three distinct groups based on their health status: children with cancer, children with other chronic illnesses, and healthy children. A total sample size of 150 participants (50 per group) will be targeted to ensure adequate statistical power for comparative analyses. Recruitment will occur at Hong Kong Children's Hospital or the cancer and chronic illness groups, and healthy children will be recruited from healthy siblings of participants or the healthy children of hospital staff with specific inclusion and exclusion criteria applied to each group to maintain homogeneity and minimize confounding variables.
NCT06978855
Background: Medical trainees frequently experience sleep disturbances, with shift work being a major contributing factor impacting their performance and overall wellbeing. Traditional treatments for sleep disorders often involve medications and hypnotics with potential side effects, highlighting the need for alternative strategies. Acupressure, particularly at the P6 (Neiguan) point, has shown promise in improving sleep and reducing anxiety. Objective: This study aimed to evaluate the efficacy of wristband acupressure applied to the P6 point in improving sleep quality, anxiety levels, and overall well-being among medical trainees. Methods: A single-blinded, cross-over randomized controlled trial was conducted at the American University of Beirut Medical Center (AUBMC), involving 10 medical trainees. Participants were randomized in blocks to either the intervention group, receiving wristband acupressure at the P6 point, or the control group, receiving acupressure at a sham point. Standardized, validated questionnaires were used to assess sleep quality (PSQI), anxiety (GAD-7), and well-being (WHO-5) before and after each intervention period. Ethical approval was obtained from the Institutional Review Board, and participant confidentiality was maintained
NCT02059421
The purpose of this project is to compare the effectiveness of Johrei therapy (JT) and Cognitive-behavioral Therapy for Insomnia (CBT-I) in the treatment of sleep disturbances in survivors of critical illness. Subjects will be recruited following discharge from the Intensive Care Unit (ICU) and followed for 6 weeks. All subjects will undergo objective measurements of sleep quality and duration at baseline and at 6 weeks. Objective measurements will be made by portable (home-based) sleep studies and will wear a watch that measures sleep. Subjective measurements will be performed by sleep questionnaires: PSQI, Epworth sleepiness scale, sleep log, and Stanford Sleepiness Scale which will be performed at baseline, 2 and 6 weeks. A blood draw and urine collection will be done at both baseline and 6 weeks. The central purpose of this proposal is to perform a comparative-effectiveness study of a complementary and alternative approach (Johrei therapy) and CBT-I in the treatment of sleep disturbances in survivors of critical illness. The investigators hypothesize that, in survivors of critical illness, Johrei therapy is superior or comparable to CBT-I in improving sleep quality (Pittsburgh Sleep Quality Index \[PSQI\] and sleep efficiency \[measured by polysomnography\]). A secondary objective is to compare the effect of Johrei therapy and CBT-I on systemic markers of inflammation and urinary biomarkers of sleep and stress. The investigators hypothesize that, in survivors of critical illness, Johrei therapy is superior or comparable to CBT-I in reducing systemic markers of inflammation and urinary biomarkers of sleep and stress. A tertiary objective is to determine whether the presence of insomnia or other sleep characteristics is associated with hospital readmissions within 30-days.
NCT05556317
the aim of this study is to investigate the efficacy of resistive exercise on insomnia in post menopausal women
NCT01942733
To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep disturbances.
NCT01855126
In conjunction with investigators at the Cecil G. Sheps Center for Health Services Research, University of North Carolina (UNC) at Chapel Hill, we propose to develop and evaluate a low-cost, minimally obtrusive device that delivers individualized light therapy to adults with early-awakening insomnia - the most common sleep disturbance in older adults, and a significant problem because of its relationship to daytime sleepiness, use of potentially hazardous sleep medication, and reduced quality of life. The proposed device will measure light/dark exposure data over 24 hours, estimate optimum timing for light delivery, and deliver an individualized light dosage while subjects are asleep. Light applied through closed eyelids in the early part of the night will delay the dim light melatonin onset, a marker of the circadian clock, and help those with early sleep onset to fall asleep later
NCT01966835
Poor sleep quality and sleep disturbances are common in patients with rheumatoid arthritis and are associated with an increased risk of co-morbidity and all-cause mortality.Few studies have examined the possibilities of improving sleep in patients with rheumatoid arthritis, and the focus has primarily been on medical treatment. Aerobic exercise training constitutes a potentially promising, non-pharmacological alternative to improve sleep. This study is a randomized controlled trial of 44 patients with rheumatoid arthritis. The aim is to investigate the effect of a moderate-to-high intensity aerobic interval training intervention on sleep quality and sleep disturbances in patients with rheumatoid arthritis. The primary hypothesis is that moderate-to high intensity aerobic exercise will improve objective measured sleep quality and sleep disturbances. The secondary hypothesis is that the intervention may improve fitness, subjective sleep quality and physical function as well as reduce pain, fatigue, depressive symptoms and improve health-related quality of life.
NCT01311193
Individuals with borderline personality disorder (BPD) frequently suffer from emotional instability, daytime fatigue and sleep disturbances. The investigators examined circadian rhythms, sleep and well-being in women with BPD under their habitual life conditions with and without light treatment. Treated women diagnosed with BPD were investigated during 3 weeks without and 3 weeks with morning LT. Rest-activity cycles were continuously measured using wrist actigraphy, together with proximal skin temperature. Saliva samples were collected weekly to determine the diurnal melatonin rhythm. A range of self-ratings and questionnaires were used to assess depression and clinical state throughout the 6-week protocol. Ten matched healthy women followed the same 6-week protocol without light treatment.