Clinical Research Directory

Development, Sensory Profile, and Sleep Quality in Preschool Children Across Different Caregiving Models

This observational study aims to examine developmental status, sensory processing, and sleep quality in preschool children aged 3 to 6 years across different caregiving models. Children raised primarily by first-degree relatives, second-degree relatives, caregivers, or in daycare settings will be compared. Data will be collected using the Denver II Developmental Screening Test, the Dunn Sensory Profile, and the Tayside Children's Sleep Questionnaire. The study will also evaluate the relationships among developmental status, sensory processing, and sleep quality, and explore whether caregiving model is associated with differences in these outcomes.

Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality

Sleep disturbances are prevalent in older patients with osteoarthrosis or fracture who are scheduled for knee or hip replacement surgery. The occurrence of sleep disturbances is associated with worse outcomes including increased risk of delirium and cardiac events, and worsened functional recovery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, anxiolytic, and analgesic properties. It exerts sedative effects via activating the endogenous sleep pathways and produces a state like non-rapid eye movement sleep, which is different from opioid- and benzodiazepine-induced sedation. Esketamine is a N-methyl-D-aspartic acid receptor antagonist and has been used as an anesthetic and analgesic. Recent studies showed that low-dose esketamine has anti-depressive and sleep-promoting effects. The investigators suppose that mini-dose dexmedetomidine-esketamine combined infusion at night can improve perioperative sleep quality in patients scheduled for knee or hip replacement surgery.

A Real-World Exploratory Study on the Sleep-Improving Efficacy of Dong'e Brand Ejiao Yuanjiang

This study employs a real-world design to evaluate the sleep-improving efficacy of Dong'e Brand Ejiao Yuanjiang. A total of 66 participants aged 25-55 will be enrolled and assessed after 60 days of continuous use.

Multidimensional Determinants of Functional Health In Women Aged 45-60

The goal of this observational study is to learn about the multidimensional determinants of functional health in women aged 45 to 60 years. The study will focus on the role of muscle strength, bone mineral density, body composition, physical activity, sleep quality, depressive symptoms, and menopause-related symptoms in functional health. The main questions it aims to answer are: 1. Does muscle strength contribute to functional health in women aged 45 to 60 years? 2. Does bone mineral density contribute to functional health in women aged 45 to 60 years? 3. How are physical activity, sleep quality, depressive symptoms, body composition, and menopause-related quality of life associated with functional health? Participants will: * Undergo handgrip strength measurement * Perform a 30-second chair stand test * Undergo bone mineral density and body composition assessment * Complete questionnaires about physical activity, sleep quality, depressive symptoms, menopausal symptoms, and quality of life * Provide demographic and clinical information

Effects of L-Theanine and Hericium Erinaceus Gummies on Psychological, Cognitive, and Sleep Quality in University Students

The THEA-HEAL Trial is an 8-week randomized controlled study investigating the effects of a daily gummy supplement containing L-theanine and Hericium erinaceus (Lion's mane mushroom) extract on stress, anxiety, cognitive performance, and sleep quality in university students in Malaysia. University life can be a stressful period associated with increased psychological distress, sleep problems, and difficulty concentrating. In this study, eligible participants aged 18-25 years were randomly assigned to either receive the active gummy supplement or no supplementation. The intervention group consumed gummies twice daily, providing a total daily dose of 180 mg L-theanine and 300 mg H. erinaceus extract. The main purpose of the study is to determine whether this nutraceutical combination can help reduce stress and anxiety and improve cognitive function and sleep quality compared with no supplementation. Additional outcomes include physical activity levels and dietary intake. Findings from this study may provide evidence on the potential role of functional food-based supplements in supporting mental well-being and cognitive health in young adults.

Bruxism Therapy of Facial Pain

This prospective, non-profit study aims to better understand how occlusal splints (gnathological splints) affect daytime and nighttime bruxism (teeth grinding) and clenching in adults with chronic myofascial pain of the jaw muscles, a common form of temporomandibular disorder (TMD). Bruxism and clenching are repetitive or sustained jaw muscle activities that can contribute to jaw pain and dysfunction, and their accurate diagnosis requires instrumental assessment of muscle activity. In this study, muscle activity will be objectively measured using a portable device (dia-BRUXO®) worn for 24 hours, which records the electrical activity of the chewing muscles during both wakefulness and sleep. Adult patients with TMD who are prescribed a night-time occlusal splint will undergo three 24-hour recordings: before using the splint, two weeks after starting treatment, and two months later. During each recording, participants will also report their facial pain levels and awareness of clenching or grinding during the day. Their results will be compared with those of a matched control group without TMD. The main goal is to compare jaw muscle activity between patients and healthy individuals, while secondary goals include analyzing how long the muscles are active and how these patterns relate to symptoms. By combining objective measurements and patient-reported experiences, this study seeks to clarify how occlusal splints influence muscle activity and symptoms, helping clinicians improve diagnosis and treatment of bruxism and TMD.

Relationship Between Sleep-Wake Quality and Nocturnal Medical Orders

The goal of this randomized controlled clinical trial is to evaluate if the implementation of an adjusted nighttime medical order protocol can improve sleep quality and stabilize physiologic parameters in hospitalized adult patients admitted to general wards. The main questions it aims to answer are: Does reducing non-urgent nocturnal medical interruptions increase total sleep time and REM duration? Does improving sleep continuity enhance subjective sleep quality and physiologic stability (heart rate, blood pressure)? Researchers will compare the intervention group (patients under an adjusted nighttime order protocol) with the control group (standard hospital care) to determine whether reorganizing nighttime medical routines improves objective and perceived sleep outcomes. Participants will: Wear a Fitbit Sense® device to continuously monitor objective sleep parameters across three hospital nights. Complete the Pittsburgh Sleep Quality Index (PSQI) at admission and discharge to assess subjective sleep quality. Undergo standard nighttime vital sign evaluations according to their assigned study protocol.

Precision ICU Care: Evaluating an AI-Driven Nursing Decision Support System for Delirium Prevention

Delirium affects up to 83% of mechanically ventilated patients in the Intensive Care Unit (ICU), often leading to longer hospital stays and long-term memory or cognitive problems. While standard care protocols (such as the ABCDEF bundle) exist, they are often difficult to implement fully due to their complexity and the heavy workload on nursing staff. To address these challenges, this study introduces a 'Precision Nursing' approach by integrating Artificial Intelligence (AI) and Virtual Reality (VR). We will implement an AI-driven system to assist nurses in making personalized care decisions more efficiently. Additionally, interactive VR technology will be used to stimulate patients' cognitive function and encourage early mobility. Our goal is to reduce the clinical burden on healthcare providers while significantly improving recovery outcomes for ICU patients.

Mitigation of Health Effects in Pregnant Women by Reducing Exposure to Heat and Air Pollution

The goal of this clinical trial is to assess the effectiveness of an intervention (combination of behavioural recommendations and technical measures) in reducing personal exposure to heat and air pollution and related health effects in pregnant women. The main questions it aims to answer are: * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce personal ambient temperature exposure, measured using a wearable device (iButton)? * Does the intervention (combination of behavioral recommendations for air pollution mitigation and use of indoor air cleaners) reduce indoor exposure to air pollution, measured using indoor air quality sensors (Purple Air)? * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce sleep difficulties experienced by pregnant women, measured using the Pittsburgh Sleep Quality Index? Researchers will compare measurements between pregnant women carrying out their daily activities in the absence of intervention (control group), those carrying out their daily activities with behavioural recommendations (recommendation intervention group) and those carrying out their daily activities with both behavioural recommendations for heat mitigation and continuous use of indoor air cleaners in their house (heat and air pollution mitigation intervention group) to see if changes in temperature exposure and sleep are different between intervention groups. Participants will: * Wear the wearable devise for continuous personal ambient temperature monitoring (ibutton) daily for a period of three months * Have their core temperature measured using an eCelsius medical capsule in three repeated assessments * Complete the Pittsburgh Sleep Quality Index questionnaire in three repeated assessments * Provide samples of urine and blood biomarkers in three repeated assessments.

Healing Care Environment and Sleep in Pediatric Intensive Care

This randomized controlled study was conducted to evaluate the effects of non-pharmacological interventions used within the framework of a healing care environment on sleep disturbances in children hospitalized in the pediatric intensive care unit (PICU). The study aimed to support sleep quality by reducing environmental stimuli and promoting comfort through supportive nursing interventions. The interventions included the use of an eye mask and headphones with audiobooks in addition to standard nursing care. Children aged 6-15 years who met the inclusion criteria were randomly assigned to control and intervention groups. Sleep disturbances were evaluated using the Sleep Disturbance Scale for Children, and physiological parameters including heart rate, respiratory rate, blood pressure, oxygen saturation, and body temperature were monitored throughout the study process. The findings of this study are expected to contribute to evidence-based non-pharmacological nursing interventions aimed at improving sleep quality and supportive care practices in the PICU environment.

Self-Acupressure and Social Jet Lag in Female Health Sciences Students

This randomized, sham-controlled trial aims to evaluate the effects of self-administered acupressure on social jet lag, sleep patterns, and sleep quality in female health sciences students. Participants will be randomly assigned to either a self-acupressure intervention group or a sham self-acupressure control group. The intervention will be performed daily for 12 weeks. Outcomes will be assessed at baseline and at the end of the intervention period, with the primary outcome being the change in social jet lag. Secondary outcomes include changes in sleep quality, daytime sleepiness, and participant blinding assessment.

Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

Cerebral palsy (CP) is a lifelong condition that affects movement and posture in children, often requiring continuous care from family members. Children with CP frequently experience sleep problems due to spasticity, pain, seizures, or behavioral difficulties. Poor sleep can negatively affect the child's health and development, as well as increase the physical and emotional burden on their caregivers. This study aims to evaluate the sleep quality of children with CP and their primary caregivers, and to examine the relationship between caregiver burden and these sleep-related factors. The study will include children aged 2 to 18 years with a diagnosis of CP and their primary caregivers (parents or legal guardians). Children's sleep patterns will be assessed using the Children's Sleep Habits Questionnaire (CSHQ). Their functional levels will be classified using the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS). Caregivers' sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI), caregiver burden with the Zarit Burden Interview (ZBI), and psychological status with the Hospital Anxiety and Depression Scale (HADS). By identifying how sleep problems are linked with caregiver burden and psychological health, this study may provide valuable insights for developing supportive intervention programs for both children with CP and their families.

Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) for Stress, Sleep, and Inflammation

The goal of this clinical trial is to learn if a novel strain of heat-killed Mycolicibacterium that is being considered by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain "Candidatus Mycolicibacterium petrae" KGA-10 (KGA-10) has effects on perceived stress, systemic inflammation, self-reported measures of sleep, and self-reported general well-being in healthy adults. This clinical trial will also learn about safety and tolerability of KGA-10. This novel Mycolicibacterium species is also referred to as NeuroAlly and MTC 0012. The questions it aims to answer are: 1) is KGA-10 associated with adverse side effects; 2) does KGA-10 reduce systemic inflammation; 3) does KGA-10 reduce perceived stress; 4) does KGA-10 improve self -reported measures of sleep; 4) does KGA-10 improve self-reported metrics of general wellbeing. Researchers will compare daily KGA-10 (1 mg mixed with microcrystalline cellulose in capsule form) to a placebo (microcrystalline cellulose in capsule form, but contains no KGA-10) to see if KGA-10 has effects on the proposed outcomes. Participants will take KGA-10 or a placebo everyday for 8 weeks and keep a daily log of their supplement intake that includes the time of day. Participants will complete a weekly survey to assess side effects experienced during the trial both related and not related to the supplement. They will complete additional weekly surveys evaluating perceived stress and self-reported measures of sleep. They will complete a survey evaluating self-reported general well-being and provide dried blood spot (DBS) samples to assess systemic inflammation at baseline, week-4, and week-8

ROBO-PAWS: Robot-Dog-Assisted Walking

Childhood cancers affect approximately 400,000 children and adolescents worldwide each year. Although advances in treatment have significantly improved survival rates, children undergoing cancer treatment continue to experience a wide range of treatment-related symptoms and complications. Among these, fatigue and sleep disturbances are particularly common and may persist throughout treatment and survivorship, negatively affecting psychological well-being, cognitive functioning, and overall quality of life. Reduced physical activity during treatment is strongly associated with worsening fatigue, impaired sleep, and decreased quality of life in pediatric oncology patients. However, treatment side effects, prolonged hospitalization, infection risk, and lack of motivating play-based activities often limit children's participation in physical activity during treatment. Recent evidence suggests that physical activity interventions may help reduce fatigue and improve well-being in children with cancer, yet engaging and age-appropriate non-pharmacological interventions remain limited, especially for younger children. This pilot randomized controlled trial aims to evaluate the feasibility and potential effects of a robot-dog-assisted walking intervention on sleep quality, fatigue, and quality of life among children aged 2-7 years undergoing cancer treatment.

Effects of Multi-component Exercise on Physical Performance and Sleep Quality in Older Adults

This quasi-experimental study evaluated the effects of an 8-week multi-component group exercise program on physical performance and sleep quality among community-dwelling older adults in Taiwan. Participants were recruited from four community care sites in central Taiwan. The intervention group participated in a structured exercise program consisting of aerobic, resistance, balance, and flexibility training conducted at a university-affiliated senior fitness club, while the control group maintained their usual community activities. Primary outcomes included physical performance and sleep quality. Physical performance was assessed using gait speed, chair stand, arm curl, grip strength, balance, and walking tests. Sleep quality was measured using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI). Heart rate recovery was evaluated as a secondary outcome. Pre- and post-intervention assessments were conducted to determine the effectiveness of the intervention.

Experimental Trial of an Employment-Based Housing Program for Adults at Risk of Homelessness

Employment-Based Housing (EBH) is a novel model that helps unstably housed individuals obtain housing and on-site employment where they are housed. The long-term goal of this project is to examine how housing and vocational services can be integrated into hospital emergency departments (EDs) as a multi-sectoral intervention. The investigators central hypothesis is that EBH provides housing, employment, and health insurance which will reduce acute care use and ameliorate non-medical determinants of health more than standard care models. The rationale is that EBH addresses multiple upstream factors that can prevent recurring use of acute care, and the combination of housing with employment services will have positive synergistic effects. This project has three specific aims: 1) Conduct a three-arm randomized clinical trial comparing EBH to passive (resource list) and active control interventions (basic vocational services) on acute care use as the primary outcome and secondary outcomes related to housing, employment, and health-related quality of life; 2) Understand the experiences of subgroups of participants receiving EBH; and 3) Identify barriers and facilitators to adoption of EBH in public healthcare systems in other cities nationally. To achieve these aims, an EBH program will be integrated into the ED of the largest safety net hospital system in Houston, Texas- the 4th largest city in the United States. The project will include a three-arm randomized trial enrolling 750 participants (250 participants per arm). The three-arm trial allows for the investigation of the unique contribution of housing over other non-medical determinants of health (employment and insurance). Participants will be randomized to one of the three arms and followed for 12 months.

Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients

The goal of this study is to determine whether a multimodal sleep pathway can enhance sleep quality in hospitalized patients with orthopedic trauma. It will also evaluate the effect of this pathway on opioid use and pain perception during recovery. The main study questions are: * Does the multimodal sleep pathway improve sleep quality and duration? * Does the pathway reduce the amount of opioids patients use during hospitalization? * Does improved sleep reduce pain interference with daily activities? Researchers will compare the multimodal sleep pathway to standard postoperative care to see if the pathway helps patients sleep better and rely less on opioids. Participants will: * Receive either the multimodal sleep pathway (zolpidem, melatonin, and sleep hygiene education) or standard care * Wear a wrist-worn actigraphy device to track sleep during their hospital stay * Complete daily questionnaires about sleep quality and pain

Determining the Relationship Between Posture, Muscle Stiffness, Pain, and Jaw Functionality in Individuals With Bruxism

Bruxism is a repetitive jaw-muscle activity characterized by teeth clenching and/or grinding, often associated with temporomandibular joint dysfunction, pain, and impaired jaw function. This cross-sectional comparative study aims to investigate the relationship between jaw functionality, posture, muscle stiffness, pain, perceived stress, and sleep quality in young adults with bruxism. A total of 48 participants will be included: 24 individuals with clinically confirmed bruxism and 24 healthy controls. Clinical and sociodemographic characteristics will be recorded using a Bruxism Assessment Form developed by dentists and physiotherapists. Posture will be assessed with the PostureScreen Mobile® application; pain intensity and thresholds will be measured using a digital algometer; masseter, temporalis, and trapezius muscle stiffness will be evaluated with a MyotonPro device. Perceived stress will be assessed using the Perceived Stress Scale-10, sleep quality with the Epworth Sleepiness Scale, and functional jaw limitation with the Jaw Functional Limitation Scale-20. Statistical analysis will be performed using SPSS (Version 20.0). Between-group comparisons will be made using t-tests or Mann-Whitney U tests depending on distribution. Correlation analyses (Pearson or Spearman) will be used to evaluate associations among variables. The primary outcome is to determine the relationship between jaw functionality, posture, muscle stiffness, and pain in individuals with bruxism. Secondary outcomes include the associations of sleep quality and perceived stress with these parameters. This study will provide novel insights into the multidimensional impact of bruxism and may guide future preventive and rehabilitative strategies.

Sleep Quality and Cognitive Functions in Adults: A Cross-Sectional Study

This observational cross-sectional study aims to examine the association between sleep quality and cognitive functions in healthy young adults. Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index, and objective sleep parameters will be collected using a wearable device over five consecutive days. Cognitive functions will be evaluated at a single assessment session using standardized neuropsychological tests, including measures of attention, executive functions, and verbal memory. The study seeks to explore relationships between subjective and objective sleep measures and cognitive performance. Findings from this study may contribute to a better understanding of how sleep quality is associated with cognitive functioning in healthy young adults.

Effect of Progressive Muscle Exercises on Sleep in Urological Surgery

Patients undergoing urological surgery are usually elderly individuals and may experience sleep problems due to factors such as fear of death, anesthesia, and uncertainty. Insomnia can also cause problems such as delayed wound healing, increased pain, tension, and difficulty complying with treatment. This study aimed to improve sleep quality by performing gradual muscle exercises on patients undergoing urological surgery.

Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients

Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients with Visual Impairment. This pilot clinical trial is testing whether a device called VeNS (vestibular nerve stimulation) can safely and effectively improve sleep in adults who are visually impaired. The study will compare the active VeNS device to a sham (inactive) device. Participants will use the device under supervision for 30 minutes a day over 4 weeks, followed by a 4-week observation period. Researchers will assess sleep improvements, safety, and how acceptable and easy the treatment is for participants. Allocation: Randomized to either active device or control device usage. Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation Sample size: The aim is to recruit a total of up to 60 participants. The study will last 8 weeks in total for each subject.

Can the Belgian Coastal Environment Improve Physical and Cognitive Health in Older Adults?

The goal of this interventional study is to learn if exposure to coastal environments improves the physical and cognitive health of older adults over the age of 60. The main questions it aims to answer are: Does coastal exposure affect physical stress levels in older adults? Does coastal exposure affect self-reported stress levels in older adults? Does coastal exposure affect cognitive measures, such as sustained attention, in older adults? Does coastal exposure affect sleep quality in older adults? Is there a difference between the various components of coastal environments (e.g. dykes, dunes,...) in their effect on older adults' physical stress? This wil be a within-subject study, in which participants get exposed to both a coastal and an urban environment to compare their response to these environments. Participants will perform a coastal and urban walk on different days, equipped with wearable sensors (namely a wrist- and chestband) to measure various parameters such as heart rate and skin conductivity. Before, during and after the walk saliva samples will be collected for cortisol analysis. Before and after the walks they will also answer some questions (on e.g. overall demographics but also self-reported mental health) and perform cognitive tests (to study e.g. sustained attention).

The Effect of an Artificial Intelligence-Supported Health Promotion Application on the Nutrition, Exercise and Sleep Habits of Adolescents

The goal of this clinical trial is to learn if the "Smart Nurse" artificial intelligence-supported mobile application improves nutrition, exercise, and sleep behaviors in high school students aged 14-18 years. The main questions it aimed to answer are: * Did the "Smart Nurse" app improve healthy nutrition and exercise behaviors in adolescents? * Did the "Smart Nurse" app improve sleep quality in adolescents? * Did the "Smart Nurse" app lower body mass index (BMI) and waist circumference in adolescents? Researchers compared participants who used the "Smart Nurse" app to participants who did not use the app to see if the app improved health behaviors. Participants: * Used the "Smart Nurse" mobile app every day for 12 weeks * Recorded their daily meals, physical activity, and sleep time in the app * Received personalized health messages based on their data * Completed health surveys and body measurements at the beginning and end of the study

Investigation of the Effect of Thoracic Manipulation and Classical Massage on Pain, Flexibility and Sleep Quality

Investigation Of The Effects Of Thoracic Manipulation And Classical Massage On Pain Flexibility And Sleep Quality In Patients With Mechanical Back Pain