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.

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

Changes in 24-hour Activity Cycle Behaviors During a Time-Restricted Eating Intervention in College-Aged Women

Time-restricted Eating (TRE) is a dietary approach that limits food intake to 4 - 12-hour windows without intentionally altering diet quality. TRE has several benefits including modest reductions in body weight and fat mass, improved glucose control, and reduced inflammatory markers. While research supports the metabolic and weight related benefits of TRE, there is limited evidence of its effects on physical activity (PA), sedentary behavior (SB) and sleep - the core components of 24-hour Activity Cycle (24-HAC), which is a holistic framework that integrates the three health-related activities. TRE research has largely focused on clinical populations, leaving its feasibility and adherence in healthy younger adults understudied. Within this group, college students' misaligned circadian rhythms and unpredictable schedules may make adherence to TRE challenging, highlighting the need for research on its practicality in this group. These outcomes are also particularly important to investigate in women, considering that SB is more prevalent among college-aged women (69%) compared to men (46%). To address these issues, we will conduct a three-week intervention to study the effects of TRE on the 24-HAC outcomes. College aged women will be screened and enrolled, then assigned to either a control or TRE group. Participants in the TRE group will self-select the timing of their 8-hour eating window which they will maintain throughout the study (with compliance on at least six days per week needed to be considered adherent). The control group will receive a basic nutrition education at the start of the study and will have no restriction on eating times. 24 HAC behaviors will be measured continuously for one-week of baseline measurement and throughout the intervention by wrist-worn ActiGraph GT9X monitors. Participants will also record the timing of their first and last meal each day and receive periodic reminders to report their hunger and satiety ratings using visual analog scales.

Virtual Reality (VR) Based Relaxation for Nausea and Comfort in Pregnancy

This study aims to evaluate the effect of a virtual reality (VR)-based visual relaxation intervention on nausea and vomiting severity, sleep quality, and comfort in pregnant women. Nausea and vomiting are common symptoms during pregnancy and may negatively affect women's quality of life and overall well-being. Non-pharmacological interventions such as VR-based relaxation may provide a safe and effective alternative to improve these symptoms. In this randomized controlled study, pregnant women will be assigned to either an intervention group receiving VR-based relaxation or a control group receiving standard care. The outcomes will be assessed using validated measurement tools for nausea and vomiting severity, sleep quality, and comfort. The findings of this study are expected to contribute to improving maternal comfort and supporting non-invasive care approaches during pregnancy.

Effect of L. Reuteri LM1063 on Sleep Health Improvement

Purpose: The purpose of this clinical trial is to evaluate the efficacy and safety of Limosilactobacillus reuteri LM1063 on improving sleep health in healthy adults. Based on the microbiota-gut-brain axis, this study aims to scientifically analyze whether the supplementation of this specific probiotic strain can enhance sleep quality. Methodology: This is a randomized, double-blind, placebo-controlled, single-center clinical trial. A total of 80 participants (40 in the test group and 40 in the control group) will be enrolled. Participants in the test group will consume 500 mg of L. reuteri LM1063 (1.0 x 10\^10 CFU/day) once daily for 8 weeks, while the control group will receive a placebo. Key Evaluations: To assess sleep improvement, various parameters will be measured before and after the 8-week intake period: * Primary Outcomes: Polysomnography (PSG) measures including sleep efficiency (SE), sleep latency (SL), total sleep time (TST), wake after sleep onset (WASO), and delta power; and the Pittsburgh Sleep Quality Index (PSQI). * Secondary Outcomes: Various sleep and stress-related scales (SSS, ESS, PSS, RSQ-W, FSS) and blood biomarkers such as melatonin, GABA, and serotonin levels. * Safety: Monitored through adverse events, vital signs, and clinical laboratory tests.

IMST for Dementia Risk Reduction

Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.

Lay-led Brief Cognitive Behavioural Therapy for Insomnia (CBT-I) Group for Older Adults in Hong Kong: A Pilot Study

The goal of this clinical trial is to study whether a Cognitive Behavioural Therapy for Insomnia (CBT-I) group led by laypersons serves as an effective tool for alleviating insomnia in older Chinese adults in Hong Kong. The main questions it aims to answer are: 1) Can the group improve subjective sleep quality? 2) What is the feasibility and acceptability of the group? Researchers will compare the intervention group with a control group. Participants will either join the intervention group or receive a self-help booklet, depending on their assignment. Both groups will complete two questionnaires over a four-week period: Baseline and Week-4 data.

Social Media Diet and Psychological Outcomes in University Students

This study aims to examine the effect of a social media diet intervention on loneliness, fear of missing out (FoMO), and sleep quality among university students. Excessive social media use has been associated with several negative psychological outcomes, including increased loneliness, heightened FoMO, and poor sleep quality. In this randomized controlled trial, university students will be randomly assigned to either an experimental group or a control group. Participants in the experimental group will follow a social media diet intervention that involves limiting daily social media use for a specified period, while participants in the control group will continue their usual social media use without restrictions. Loneliness, FoMO, and sleep quality will be measured at baseline and after the intervention using validated scales. The findings of this study are expected to provide evidence on whether reducing social media use can improve psychological well-being and sleep quality among university students.

Evaluation of Emotional Responses Using the I-Motions System and Self-assessment Questionnaires, and Assessment of Postoperative Anatomical and Structural Units (TMJ and Masticatory Muscles) in Orthognathic Surgery Patients

Orthognathic surgery is a surgical procedure involving one or both jaws to correct skeletal discrepancies, restore proper occlusion, and improve facial aesthetics. Individuals with dentofacial abnormalities often experience difficulties with chewing, biting, and social interaction, which may negatively impact psychological well-being and overall quality of life. Orthognathic surgery must be combined with orthodontic treatment before and after the operation to ensure optimal functional and aesthetic outcomes. The conventional "orthodontics-first" approach involves prolonged preoperative orthodontic treatment (typically 12-24 months, sometimes up to 48 months) to decompensate dental alignment and reveal the true skeletal discrepancy prior to surgery. Although effective for achieving stable occlusion, this method is time-consuming and may temporarily worsen facial aesthetics and function during the preoperative phase. The "surgery-first" approach eliminates or significantly reduces preoperative orthodontics, performing surgery first followed by postoperative orthodontic treatment. This method shortens overall treatment time, provides immediate aesthetic improvement, facilitates favorable orthodontic tooth movement, and may lead to earlier improvement in conditions such as obstructive sleep apnea. It is generally recommended for patients with mild anterior crowding, minimal transverse discrepancies, a flat or mild curve of Spee, and normally inclined incisors. Common surgical techniques include genioplasty, bilateral sagittal split osteotomy (BSSO), oblique ramus osteotomy, and Le Fort I osteotomy. Whenever possible, procedures are performed intraorally to avoid visible scarring. Orthognathic surgery induces not only anatomical and functional changes but also psychological adaptations. Soft tissues, masticatory muscles, and the temporomandibular joint (TMJ) adapt to new skeletal relationships, contributing to improved facial balance and patient self-perception. However, there is currently no unified diagnostic algorithm to comprehensively evaluate postoperative anatomical, physiological, and socio-emotional changes. Emotional satisfaction, TMJ structural changes, muscle strength variations, sleep quality, and pain outcomes remain insufficiently studied. The study proposes two hypotheses: the null hypothesis (H0) assumes no postoperative changes in TMJ anatomy, masticatory muscle strength, emotional response, facial pain, sleep quality, or depressive characteristics; the alternative hypothesis (H1) assumes that such changes do occur. The objectives are to evaluate masticatory muscle strength and structure, TMJ anatomical changes, emotional state, depression and anxiety predisposition, sleep quality, facial pain, and aesthetic perception before and after surgery. The study will include up to 100 patients undergoing bimaxillary orthognathic surgery (with or without genioplasty) at the Lithuanian University of Health Sciences Kaunas Clinics. Assessments will be conducted preoperatively, immediately postoperatively, and 3-6 months after surgery. Methods include CBCT imaging for TMJ evaluation, electromyography for masseter muscle strength, emotional analysis using the iMotions platform (facial expression analysis and electrodermal activity), and validated questionnaires (PHQ-15, HADS, VAS). Strict ethical standards will be followed in accordance with international guidelines, with informed consent obtained from all participants. No additional financial costs or conflicts of interest are declared. The expected outcome is to determine correlations between anatomical, functional, psychological, and aesthetic changes following orthognathic surgery, providing a more comprehensive understanding of patient satisfaction and overall quality-of-life improvement.

Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD

This is a prospective, multicenter, observational cohort study, which plans to enroll patients with active IBD who are scheduled to initiate IFX or VDZ treatment between October 2025 and October 2027 at Xijing Hospital, Tang-du Hospital, and Air Force 986 Hospital. All patients will undergo HRV monitoring at baseline, Week 2, Week 6, and Week 14. The HRV monitoring results will be blinded to both physicians and patients. Based on the efficacy assessment at Week 14, patients will be divided into response and non-response groups for comparison, to analyze the strength of association between baseline HRV parameters and the achievement of clinical response. The study plans to enroll 100 IBD patients, with 50 in the IFX treatment group and 50 in the VDZ treatment group.

Experimental Trial of an Employment-Based Housing Program for Adults at Risk of Homelessness: Housing Integrated With Residential Employment

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.

Assessing the Effects of Cool Roofs on Indoor Environments and Health in Colima, Mexico

Ambient air temperatures in Mexico have broken record highs in 2024. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions in the northern zone of Mexico are susceptible to increased heat exposure. Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in household occupants. The long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat in Mexico. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in Colima, Mexico.

The Relationship Between Ultrasonographic Findings and Sleep Quality in Carpal Tunnel Syndrome

The aim of our study is to determine the relationship between disease severity and sleep quality in CTS patients and to compare the findings with healthy controls.

The Effect of Music on Anxiety Levels and Sleep Quality in Patients Who Have a Myocardial Infarction

Music therapy is a non-invasive method with no side effects and can be administered independently by a nurse. Nevertheless, it should be noted that music therapy can be discontinued if any adverse effects are experienced by patients during the research process. After completing the music listening session, eye masks and earplugs, which are effective in reducing sleep problems in patients, will be applied from 11:00 p.m. to 7:00 a.m. All patients will be asked to complete the DAÖ at 10:00 PM and 10:30 PM. The RCUÖ will be requested to be completed by all patients between 8:00 AM and 9:00 AM the following morning.

Assessing the Effects of Cool Roofs on Indoor Environments and Health

Ambient air temperatures in Asian, Latin American, African, and Pacific climate hotspots have broken record highs in 2024, driven by man-made climate change. Solutions are needed to reduce heat exposure in communities. Sunlight-reflecting cool roof coatings passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions globally - for example in informal settlements, slums, and low-socioeconomic households - are especially vulnerable to increased indoor heat exposure. Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are being experienced in communities least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in occupants. The long-term research goal is to identify viable passive housing adaptation technologies with proven health and environmental benefits to reduce the burden of heat stress in communities affected by heat globally. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in five urban climate hotspots: Ouagadougou, Burkina Faso; Colima, Mexico; Ahmedabad, India; Niue; and Tavua, Fiji.

The Effects of Acupressure and Massage Following Cesarean Section

Cesarean section births have rapidly increased both in our country and worldwide in recent years. According to OECD data, one in four births worldwide and one in two births in our country is a cesarean section. The cesarean section has become one of the most frequently performed surgical interventions. The incision from a cesarean section causes pain, mobilization issues, and delays in mother-infant interaction. The choice of pharmacological methods used after a cesarean section is often limited by concerns about the baby and breastfeeding, leading to inadequate pain management and causing women to experience moderate to high levels of pain. Pain negatively affects individuals' comfort, leading to sleep disturbances, fatigue, and a decreased quality of life. It makes daily activities and responsibilities as individuals more challenging to manage. There is a need for nurses, in their primary caregiver role, to adopt a multidisciplinary approach to pain management and to develop their skills in using non-pharmacological methods. These methods should be clinically applied and proven effective. Acupressure and massage are long-standing, cost-effective, easy-to-apply, and effective methods used to reduce pain. This study aims to reduce pain and fatigue and improve sleep quality in women who have undergone a cesarean section by applying acupressure and massage in the postoperative period, thereby preventing the chronicization of these problems.

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.

Step Count and Treatment Response in Neoadjuvant Breast Cancer

This prospective multicenter observational study (NEOBRE-STEP) investigates the impact of daily step counts, measured by Huawei Fit 2 smartwatches, on treatment response in patients with non-metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer undergoing neoadjuvant systemic therapy. Patients will wear smartwatches to continuously record step counts, activity intensity, sleep, and heart rate. Patient-reported outcomes, including sleep quality (Pittsburgh Sleep Quality Index, PSQI) and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30), will be assessed at baseline and after treatment. The primary outcomes are pathological complete response (pCR) and Miller-Payne score. Secondary outcomes include sleep quality, quality of life, perioperative outcomes, and feasibility of smartwatch monitoring.

Investigation of the Relationship Between Periodontitis and Sleep Quality

This project aims to investigate the relationship between periodontitis and sleep quality. Its originality lies in evaluating the association between periodontal status and sleep quality together with salivary interleukin-6 (IL-6), interleukin-6 (IL-10) IL-10, and pentraxin-3 levels. In particular, examining the relationship of sleep quality with biological, psychological, and lifestyle factors through periodontitis and salivary IL-6, IL-10, and pentraxin-3 levels has not been previously studied in the literature. Methodologically, periodontal status will be determined through clinical examination; participants' Pittsburgh Sleep Quality Index and Multidimensional Fatigue Inventory scores will be recorded; and salivary IL-6, IL-10, and pentraxin-3 levels will be measured. The obtained data will be compared using statistical analyses to determine the strength of the relationship between periodontitis severity and sleep quality. From a management perspective, the project will be conducted following approval from the ethics committee. In terms of broader impact, the results are expected to scientifically demonstrate the relationship between periodontitis and sleep quality, contribute to the adoption of a holistic health approach in clinical practice, and increase public health awareness. Additionally, the project is expected to provide a foundation for future research on the relationship between oral health and quality of life.

The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy

This is a study to test if performing airway exercises to improve snoring and sleep apnea using a mobile phone app is better than using a hardcopy guide.

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 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

CF Wellness Program

This study is a pilot randomized control trial (RCT; N=80) comparing the Cystic Fibrosis Wellness Program (CFWP) to usual care (UC) to evaluate (1) Intervention Adherence (completion of the CFWP Coaching Sessions) (2) Study Retention (completion of the Week 15 assessment) and (3) Data Quality (valid daytime and nighttime fitness tracker data). A secondary aim is to gather preliminary data to determine if the CFWP has a clinically significant signal over usual care to improve fatigue, sleep, and physical activity (PA) and reduce sedentary behavior.

The Effect of Three-Dimensional Exercises ( Schroth Method ) on Trunk Muscle Endurance, Sleep Quality, and Quality of Life in Adolescents With Hyperkyphosis

Adolescence is a critical period for spinal growth, and progression of thoracic hyperkyphosis may lead to pain, weak trunk muscles, sleep disturbances, and reduced quality of life. This study aims to investigate the effects of three-dimensional exercise program based on the Schroth Method on trunk muscle endurance, thoracic kyphosis angle, pain, sleep quality and quality of life in adolescents aged 12-18 years with hyperkyphosis.