Clinical Research Directory

Evaluation of Innovative School-based Interventions on Health Outcomes Among Primary School Students During Post COVID-19 Pandemic

Objectives: (1) to evaluate the feasibility of innovative school-based interventions on health outcomes (psychological well-being, depressive symptoms, anxiety symptoms, physical activity, sleep duration, and sleep quality) among primary students in the post-COVID-19 pandemic period; (2) to explore children's experience of intervention; (3) to evaluate the effects of innovative school-based (WeJoy + WeHop) on depressive symptoms, physical activities, and sleep quality among primary 3 to 5 school children. Method: Two phases of the study will be conducted, including feasibility pilot study and main study. In phase 1, a sample of 40 school children will be recruited from two community centers for feasibility test and semi-structured individual face-to-face interview. In phase 2, a total of 408 school children will be recruited from primary schools in Hong Kong. This study will adopt a 2 two-group pre and post-design. Participants are randomly assigned equally into 1 intervention group (WeJoy+WeHop) and 1 control group (Routine Extra curriculum Activity). Participants will be assessed at baseline and post-intervention. The outcomes are depressive symptoms, physical activities, and sleep quality, using the Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC), the Chinese Version of the International Physical Activity Questionnaire (IPAQ-C), and the Chinese version of the Pittsburgh Sleep Quality Index (PSQI-C). Data analysis: Descriptive and inferential statistics will be performed to examine the research objectives.

Sleep Treatment for Teens (RCT Phase)

The purpose of this research study is to compare (vs. treatment as usual) a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents. The investigators propose to test the feasibility, acceptability, and effectiveness of dCBT-I in a two-site (Rutgers and Old Dominion University) pilot study trial. Adolescents, 14-18 years-old, recently hospitalized for suicide risk with co-occurring insomnia (n=80, 50% at each site), will receive either dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU) or TAU alone. Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.

Sleep and Blankets

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.

A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep

The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are: Does 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and/or objectively measured attention more than placebo? Researchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD. Participants will: * Take iron supplements every day for 3 months * Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention * Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment

Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.

Among older adults (≥65 years), use of sleeping pills, such as benzodiazepines and other sedative-hypnotics, to treat sleep problems is common. While sleeping pills are effective in the first few weeks of use, their effect diminishes significantly after that. Especially older adults are susceptible to significant adverse effects of sleep pills, yet stopping sleeping pills remains challenging. BE-SAFE aims to conduct a randomised study testing a patient-centred intervention to reduce sleeping pill use and to improve patient safety and quality of care focusing on implementation aspects. The intervention addresses knowledge and practice gaps related to discontinuation of sleeping pills in older adults with sleep problems.

Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery

This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered school-aged children undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Children's Sleep Habits Questionnaire (CSHQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received a short intensive cognitive-behavioral intervention 7-14 days before surgery, and no intervention was imposed on the control group. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.

Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery

This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered infants and toddlers undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Brief Infant Sleep Questionnaire (BISQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received sleep hygiene education and a bedtime routine based on touch, the control group received only sleep hygiene education. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.

Impact of Weighted Blankets on Sleep Quality

Weighted blankets have been used to improve sleep quality in children with neurodevelopmental disorders. It is not known, however, whether weighted blankets can improve overnight sleep in healthy adults and those with poor sleep quality and what is the optimal weight of those blankets for achieving the best results. AIMS: The purpose of the present study is to investigate the effect of 4 different weights of weighted blankets on sleep in participants with low sleep quality.

Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness

The aim is to study a sleep intervention with weighted blankets in children with ADHD and sleep problems regarding 1) short- and long-term effects on sleep and health-related outcomes in comparison with standard treatment (melatonin), 2) barriers and facilitators to implementation in routine clinical practice, and 3) health-economic outcomes.

The Impact of Melatonin Lotion on Sleep and Mental Health

The purpose of this study is to examine the effect that melatonin lotion has on sleep quality, the nervous system, and mental health. Melatonin is a hormone secreted by the brain that regulates sleep and might improve depression and anxiety symptoms. The goal is to determine whether melatonin in lotion form is an effective treatment for young adults with inadequate sleep and might improve mental health. Participants will fill out surveys, wear an actigraph (a wrist-worn device that measures sleep), wear a heart rate monitor (a strap worn around one's chest), and provide nightly saliva samples during treatment weeks. In one of the two treatment weeks, participants will receive a lotion that contains melatonin. During the other week they will receive a control treatment that will be lotion with no melatonin, and there will be a week in between with no treatment at all.

Co-occurence of Mental Illness and Problematic Alcohol Use: an Internet-based Cognitive Behavior Therapy Intervention

The goal of this clinical trial is to learn if internet-based cognitive behavior therapy (ICBT ) works to treat co-occurent of problematic alcohol use and mental illness including mild to moderate symptoms of either depression, anxiety, stress or disturbed sleep. The main questions the study aims to answer are: * Does the ICBT program lower the self-rated suffering from mental illness? * Does the ICBT program lower the self-reported alcohol intake? Researchers will compare the ICBT program to the participants who are rancomized to a control grout that receives weekly attention from the research team, to see if the treatment works. In both groups, the participants will have the opportunity to ask for support from a therapist during the week days. Participants are adults living in Sweden. They will: * Receive an ICBT program supported by a trained therapist. It consists of modules that the participants will work with on their computer for 10 weeks. Some modules will be compulsory and other optional for the participants. * Fill out forms to rate their mental illness and alcohol intake at the start and the end of the study as well as once every week during treatment. Primary outcome measures are depression, anxiety and stress symptoms (measured with Depression Anxiety and Stress Scale 21 (DASS-21)) and alcohol intake measured with self-reported amounts. Other, secondary, outcome measures used will for example be about insomnia symptoms and disability assessment. Pre-treatment measurement, post-treatment measurement and 6-months and 12-months follow up is planned to be collected through an online survey.

Use of CBD in the Treatment of Anxiety

This study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms.

WhatsApp-based Psycho-socio-educational Intervention (WeLove) for Prevention of Psychological and Sleep Problems in Pregnant Women and Their Partners: A Three-arm Double-blinded Pilot Randomised Controlled Trial

Objectives: (1) evaluate the feasibility and acceptability of the WhatsApp-based psycho-socio-educational intervention (WeLove); (2) preliminarily examine the effects of the intervention on psychological symptoms (depression, anxiety, stress symptoms), sleep quality, and life satisfaction; and (3) preliminarily examine the interdependence between psychological symptoms and sleep quality in pregnant women and their partners. Methods: The investigators will use WhatsApp to provide the six sessions of the intervention, which include psychological, social, and educational components. A three-arm double-blinded pilot randomised controlled trial (RCT) is used in 60 couples, followed by individual face-to-face interviews for process evaluation in 10 to 20 couples based on data saturation. Participants will be assigned to one of three groups and 20 couples per group: intervention 1 (couples for WeLove), intervention 2 (pregnant women for WeLove), or the control group (use WhatsApp as normal). Participants will be assessed pre- and post-intervention. Generalised estimating equation analysis and thematic analysis will be performed to examine the research objectives.

Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery

This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in adult patients undergoing cardiac surgery. The study will include adult patients undergoing coronary artery bypass grafting and/or valve surgery with concomitant sleep disorders, as assessed by the Pittsburgh Sleep Quality Index. All participants will be randomly assigned to placebo, placebo + cognitive behavioral therapy, and melatonin + cognitive behavioral therapy in a 1:1:1 ratio. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative cognitive function, sleep quality, and severity and duration of delirium. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.

Preoperative Sleep Disorders and Postoperative Delirium in Children Undergoing Congenital Heart Surgery

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.

Good Nights Sleep Program to Improve Child and Family Sleep

The purpose of this study is to pilot a randomized clinical trial designed to improve the sleep environments, sleep hygiene practices, and the duration and quality of sleep of children and parents in low-income families. It is hypothesized that child and parent sleep (assessed through subjective reports of sleep, sleep environments, sleep hygiene practices, and objective sleep data via sleep actigraphy collected with Fitbit watches) in the intervention group will improve between Week 2 (intervention session) and Week 4 (post-intervention session) as compared to child and parent sleep in the waitlist-control group.