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NCT06893575
Heart failure (HF) is a growing global health issue, with increasing prevalence among aging populations. In Turkey, the prevalence of HF was 2.114% in 2022, affecting approximately three million individuals. HF patients often experience poor sleep quality due to symptoms like dyspnea, fatigue, and fluid retention, which significantly impact their overall health and quality of life. Sleep disorders, particularly obstructive and central sleep apnea, are commonly reported among HF patients, exacerbating disease progression and increasing morbidity. Nurses play a crucial role in improving HF patients' self-care behaviors, including sleep hygiene interventions. Sleep hygiene consists of non-pharmacological strategies to improve sleep quality, such as maintaining a regular sleep schedule, avoiding electronic devices before bed, and minimizing caffeine and alcohol intake. However, behavior change in sleep hygiene requires structured intervention models, such as the Transtheoretical Model (TTM), which provides a stepwise approach to behavioral change, moving individuals through different stages from precontemplation to maintenance. TTM has been successfully applied in chronic disease management, including smoking cessation, diabetes self-care, hypertension control, and physical activity promotion. However, its application in HF patients, particularly for sleep interventions, remains underexplored. The limited existing studies suggest that HF patients often remain in the contemplation or preparation stages, indicating the need for tailored interventions to facilitate behavior change. Advancements in digital health have enabled home-based sleep monitoring through wearable devices and mobile applications. Smartwatches, such as the Mi Band, provide real-time data on sleep parameters, offering a non-invasive alternative to traditional clinical sleep studies. Additionally, WhatsApp-based interventions have gained attention in healthcare, proving effective in chronic disease management by enhancing patient education, treatment adherence, and remote monitoring. WhatsApp facilitates real-time communication between patients and healthcare providers, reducing hospital readmissions and improving self-care practices. This study proposes a WhatsApp-based, TTM-guided sleep intervention for HF patients to improve sleep quality and self-care behaviors. Unlike previous studies, which primarily focus on general self-care education, this project integrates TTM with a digital platform to support sustained behavior change. Participants will receive personalized sleep hygiene guidance through WhatsApp, with regular reminders and real-time support. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) and Sleep Hygiene Index (SHI), alongside objective sleep parameters measured via smartwatches. The impact on quality of life (QoL) will be evaluated using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Hypotheses H1. The WhatsApp-based, TTM-guided sleep health program will significantly improve subjective sleep quality in HF patients. H2. The WhatsApp-based, TTM-guided sleep health program will significantly improve sleep hygiene in HF patients. H3. The WhatsApp-based, TTM-guided sleep health program will significantly improve quality of life in HF patients. This project is the first study to integrate TTM-based behavior change strategies with a WhatsApp sleep intervention for HF patients. The findings will provide novel insights into digital health interventions for chronic disease management and offer a scalable, cost-effective approach to improving sleep hygiene in HF populations.
NCT07181577
Purpose The primary aim of this research project is to evaluate whether a special blanket is an effective intervention for improving sleep among young people aged 16-24 with sleep disturbances. Sleep problems are increasingly common among Danish youth, with approximately one in five reporting significant sleep difficulties in the past 14 days. This trend has been rising steadily since 2010 and is mirrored internationally. Sleep disturbances are linked to a wide range of physical and mental health problems, including stress, anxiety, and depression, as well as negative effects on academic performance and social relationships. Early intervention is crucial to prevent chronic insomnia and poor mental health outcomes in adulthood. Current treatments include specialized psychological therapies and medication. However, psychological therapies require extensive time and commitment, and medication carries risks of side effects, tolerance, and dependency, making non-pharmacological, safe, and accessible alternatives necessary. The special blanket is believed to promote relaxation through stimulation of the tactile and proprioceptive systems. Although promising in clinical and pedagogical contexts for certain populations (e.g., children with developmental disorders and adults with neurological conditions), there is limited scientific evidence regarding its efficacy and underlying mechanisms, particularly among youth with sleep disturbances. Methods and Study Design This project is a Phase 1 randomized controlled trial (RCT) assessing the effect of 4 weeks of using a special blanket on sleep problems among young people aged 16-24, as well as the impact on participants' mental and physical health. Additionally, the study investigates possible stress-related mechanisms involved in the use of the special blanket. Following the 4-week intervention, an open-label extension phase of 8 weeks (Phase 2) will explore continued use and acceptability of the blanket. Eligible participants, screened for sleep problems, will be randomly assigned to one of three groups: Group 1: receives a special blanket (Blanket A) for home use over 4 weeks. Group 2: receives another special blanket (Blanket B) for 4 weeks. Group 3 (observation group): no blanket provided but followed for 4 weeks to monitor changes in sleep problems. The 4-week intervention phase (Phase 1) includes baseline (T1, week 0), mid-intervention (T2, week 2), and post-intervention (T3, week 4) online assessments. Sleep disturbances, physical and mental health, and stress-related mechanisms will be measured using validated questionnaires administered through REDCap. The first 40 participants in Groups 1 and 2 will additionally provide saliva samples and wear a circadian rhythm monitor (activity watch). In Phase 2, participants in Groups 1 and 2 may continue using the blanket or revert to their usual bedding. At the end of Phase 2 (T4, week 12), follow-up questionnaires will assess sleep and user experience, including satisfaction, perceived benefits, barriers, and drawbacks of the blanket. Group 3 will then be offered a special blanket for an 8-week trial. Participants The investigators aim to recruit 672 young people aged 16-24 with sleep problems. Inclusion criteria are age 16-24 years and sleep problems measured by Insomnia Severity Index (score \>10). Exclusion criteria are any underlying somatic, psychological, or neurological condition significantly affecting sleep quality; use of medications affecting sleep; pregnancy; shift work or night work; previous use of special blankets for sleep improvement and insufficient Danish language skills (questionnaires in Danish). Significance and Relevance The investigators anticipate that the findings will contribute to the current understanding of the non-pharmacological management of sleep problems, related mental and physical health outcomes, and underlying stress-related mechanisms of special blanket interventions. The results will be relevant to health professionals working with sleep problems, but also to adolescents and younger adults with sleep problems and their parents. New clinical guidelines on sleep problems in children and adolescents recommend non-pharmacological treatments as the first choice, specifically mentioning the potential efficacy of special blankets. The proposed project will help inform further development of such guidelines and related clinical practice. If special blankets are found to be effective in reducing insomnia, they could serve as an inexpensive, easily disseminated, and administered treatment with no known side effects, with the potential to greatly reduce the personal, as well as societal costs of insomnia.
NCT06686550
The investigators are going to conduct a prospective observational cohort study in pediatric patients aged 28 days to 14 years old scheduled for elective cardiac surgery with cardiopulmonary bypass. The primary purpose of this study is to explore the effect of preoperative sleep disturbance on the incidence of postoperative delirium. Sleep status will be assessed using the Brief Infant Sleep Questionnaire(BISQ) and Children's Sleep Habits Questionnaire (CSHQ), and postoperative delirium status will be evaluated by Cornell assessment of pediatric delirium(CAPD). During the peri-operative period, children will wear actigraphs to record their sleep parameters.
NCT02370173
Sleep disturbance is nearly ubiquitous among individuals suffering from PTSD and is a major problem among service members returning from combat deployments. The proposed study aims to test a novel, inexpensive, and easy to use approach to improving sleep among service members with PTSD. Primary outcome measures will include not only PTSD symptom improvement but also include neuroimaging of brain structure, function, connectivity, and neurochemistry changes. The proposal is firmly grounded in the emerging scientific literature regarding sleep, light exposure, brain function, anxiety, and resilience. Prior evidence suggests that bright light therapy is effective for improving mood and fatigue, and our pilot data further suggest that this treatment may be effective for improving daytime sleepiness and brain functioning in brain injured individuals. Thus, this intervention, in our own research and in the work of others, has been shown to affect critical sleep regulatory systems. Improving sleep may be a vital component of recovery in these service members. Our approach would directly address this issue. Our preliminary data have shown that this approach is extremely well tolerated and is effective for improving sleep, mood, cognitive performance, and brain function among individuals with brain injuries. Finally, the potential impact of this study is high because of the capability of transitioning the research to direct clinical application almost immediately. If the bright light treatment is demonstrated as effective, this approach would be readily available for nearly immediate large-scale implementation, as the devices have been widely used for years in other contexts, are already safety tested, and commercially available from several manufacturers for a very low cost. Thus, the impact of this research on treating PTSD would be high and immediate.
NCT02374918
The purpose of the research study is to understand the effectiveness of a six-week course of light exposure on cognitive functioning, mood, activity, and sleep in people that have suffered a head injury leading to a concussion.
NCT03640533
The proposed study aims to examine the effectiveness of Nanit-Insights, an app-based intervention for parents who wish to improve their infant's sleep.