Clinical Research Directory

Infant Swing and Sleep-Wake Cycles

This study was planned to determine the effects of automatic baby swing application on the sleep-wake cycle, comfort behaviors and physiological parameters of babies in the neonatal intensive care unit.

Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

Cerebral palsy (CP) is a lifelong condition affecting movement and posture, often requiring substantial care from family members. Children with CP frequently experience sleep disturbances associated with motor impairment, pain, seizures, and other clinical factors. Sleep difficulties may also be associated with poor sleep quality, psychological symptoms, and increased burden among caregivers. This single-center, observational, cross-sectional study evaluated sleep characteristics in children with CP, caregiver sleep quality, and caregiver burden, as well as their associations with functional status and caregiver psychological symptoms. The study included 61 children with CP and their primary caregivers. Eligible children were aged 2-18 years. Children's sleep characteristics were assessed using a 33-item parent-reported questionnaire adapted from the Children's Sleep Habits Questionnaire (CSHQ), which was not identical to the validated Turkish CSHQ. Children's functional characteristics were evaluated using GMFCS, MACS, and CFCS. Caregiver sleep quality, caregiver burden, and psychological symptoms were assessed using the Pittsburgh Sleep Quality Index (PSQI), Zarit Burden Interview (ZBI), and Hospital Anxiety and Depression Scale (HADS), respectively. The study was designed to examine associations among child sleep characteristics, caregiver sleep quality, caregiver burden, and psychological well-being.

Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults

This randomized, double-blind, placebo-controlled trial evaluates whether MAGNESIO TOTAL, a dietary supplement containing magnesium bisglycinate and magnesium malate (215 mg elemental magnesium per day), improves sleep quality and health-related quality of life in adults aged 18 to 65 years with subjective sleep complaints. Participants will take the supplement or an identical placebo for 8 weeks. The study will also explore changes in metabolic, inflammatory and oxidative stress markers.

Curcumin Nano Patch and Autonomic Function in Shift-Working Healthcare Professionals

This randomized, open-label, placebo-controlled crossover study compares a curcumin-containing patch with a cooling placebo patch without curcumin in healthcare professionals who work rotating shifts. It evaluates heart rate variability, stress, sleep quality, anxiety and depressive symptoms, and examines the relationships between wearable measurements and questionnaire scores. Participants are healthcare professionals aged 20 to 60 years at Taipei Medical University Shuang Ho Hospital in Taiwan. Each participant receives both patches in randomly assigned order. Each patch is used for at least 14 days, for 8 hours per day, with a washout of at least 14 days between periods. Participants and researchers know which patch is used. Wearable measurements are compared within the same participant across the two patch periods. Questionnaires are completed at the beginning and end of each period.

Effects of Swimming and Tennis on Mental Health, Fatigue, and Sleep in Young Women

This study compared the effects of swimming and tennis on mental health, fatigue, and sleep quality in young women who were not regularly physically active. A total of 34 women aged 18-25 years were randomly assigned to either a swimming group or a tennis group. Both groups participated in supervised exercise sessions lasting 45 minutes, three times per week, for eight weeks. Participants completed questionnaires before and after the exercise programs to assess anxiety, depressive symptoms, psychological well-being, perceived stress, fatigue, and sleep quality. Thirty participants completed the study and were included in the final analysis. The purpose of this study was to determine whether swimming and tennis had different effects on psychological health, fatigue, and sleep quality in physically inactive young women.

Characterizing the Effects of Platelet-Rich Fibrin (PRF) as a Palatal Wound Dressing on Quality of Life and Sleep Following Mucogingival Surgery. Study Was Conducted at the Air Force Post Graduate Dental School. All HIPPA Consents and Research Informed Consents Are Located at JBSA-Lackland.

The goal of this clinical trial (2-arm) is to determine if the application of platelet rich fibrin (PRF) to palatal donor sites influence patients quality of life, sleep efficiency, and healing following mucogingival surgery. All patients were enrolled in the Air Force Post Graduate Dental School periodontics program and each patient required mucogingival surgery. The main question\[s\] it aims to answer \[is/are\]: * Does the application of PRF to palatal donor sites influence patient's quality of life following mucogingival surgery. \[outcome measure 1\] * Does the application of PRF to palatal donor sites influence patient's sleep quality following mucogingival surgery. \[outcome measure 2\] * Does the application of PRF to palatal donor sites influence palatal healing following mucogingival surgery. \[outcome measure 3\] Researchers will compare the application of PRF (test) as a palatal dressing to a commercially available product (control; oxidized cellulose membrane or collagen dressing) to determine the difference of effects. Participants will be randomly assigned to either receiving PRF or a commercially available product on the day of surgery. A survey response will be conducted at five time points (pre-operative, 24-hours, 72 hours, 1 week, 2 week) to obtain a quality of life metric. Sleep data was collected via a wearable device one week pre-surgical intervention and two weeks postoperatively. Finally, a clinical healing index was performed at 1 and 2 weeks post-operatively to obtain a healing score.

Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea

Although exercise and physical activity have shown beneficial effects in individuals with obstructive sleep apnea (OSA), evidence regarding the effects of daily physical activity habits on sleep quality and respiratory parameters remains limited. This study aims to investigate these associations in individuals with OSA.

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.

Visual and Auditory Stimulation in Intensive Care Patients

This study is a randomized controlled experimental clinical trial designed to investigate the effects of visual and auditory stimulation on dyspnea severity, sleep quality, and anxiety levels in patients receiving noninvasive mechanical ventilation (NIMV) support in a secondary-level cardiac intensive care unit. A total of 44 patients (22 in the intervention group, 22 in the control group) are planned to be included in the study. Patients in the intervention group will be exposed to images of the Northern Lights projected onto the ceiling and white noise simultaneously for 30 minutes each night over two nights. The control group will receive no intervention other than routine nursing care. Data will be collected using the Dyspnea-12 Scale, the State Anxiety Inventory, the Richards-Campbell Sleep Scale, and a physiological parameters form. The study results are expected to contribute to evidence-based practices aimed at reducing dyspnea and anxiety, improving sleep quality, and enhancing patient comfort in intensive care patients through non-pharmacological methods.

Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality

single-center, randomized, cross over, double-blind, placebo controlled intervention study

Effects of Different Footbath Immersion Depths on Sleep Quality Among Older Adults in Long-Term Care Facilities

Sleep disturbances are common among older adults residing in long-term care facilities. Warm-water footbaths may help improve sleep quality; however, different immersion depths may affect the body's response to warming. This study examined the effects of warm-water footbaths at different immersion depths on subjective and objective sleep quality among older adults living in long-term care facilities. A total of 40 older adults aged 65 years or older from six long-term care facilities in southern Taiwan participated in a crossover study. The study compared three conditions: ankle-level footbaths, below-knee footbaths, and routine care without a footbath. During the footbath interventions, participants immersed both feet in water at 42°C for 15 minutes approximately one hour before bedtime. Subjective sleep quality was assessed using the Verran and Snyder-Halpern Sleep Scale, and objective sleep quality was measured using wrist actigraphy.

Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App

The goal of this controlled pre-post-trial is to test the Accu-Chek SmartGuide continuous glucose monitoring (CGM) system and whether its predictive features provide additional benefits for adults with type 1 diabetes or insulin- treated type 2 diabetes. The main questions this study aims to answer are: * Does using the Accu-Chek SmartGuide together with the Predict App change participants' fear of hypoglycemia? * Does the Predict App affect other psychological and behavioral outcomes, such as sleep quality, confidence in preventing hypoglycemia, diabetes- related distress, and diabetes empowerment? * Does the use of the predictive features affect glucose levels and the way participants use and respond to CGM alarms and trend information? Participants will use the Accu-Chek SmartGuide for 6 weeks. During the first 2 weeks, participants will use the CGM system without the predictive features. During the following 4 weeks, participants will use the system together with the Accu-Chek SmartGuide Predict App. Participants will complete online questionnaires at two time points (after 2 and after 6 weeks) and answer short questions twice a day through a smartphone app during the first 2 weeks and the last 2 weeks of the study. CGM data will be collected throughout the study. A subgroup of 10 participants will also be invited to take part in an online interview about their experiences with the predictive features.

Effects of Respiratory Muscle Strengthening and Diaphragmatic Breathing on Shoulder Pain and Disability

The aim of the study is to investigate the effects of respiratory muscle strengthening and diaphragmatic breathing on pain levels, respiratory capacity and sleep quality in participants with shoulder pain and disability.

Effect of Opioid-free Anesthesia on Sleep Quality, Cognitive Function and Recovery Quality After General Anesthesia in Elderly Patients

Postoperative cognitive dysfunction (POCD)is a common well disorder of the central nervous system after surgery, mainly manifested by impaired memory, spirit, language ability or other aspects of brain function. POCD, which often occurs in elderly patients over 65 years, The recent phase is recommended to be changed to perioperative neurocognitive impairment ( PND), The PND is used to describe the cognitive function changes that occur before and within 1 year after surgery, Based on the time of disease onset, It can be divided into neurocognitive impairment existing before surgery, postoperative delusion (POD) occurring hours to days after surgery, neurocognitive recovery delay (DNR) within 30 days after surgery, and postoperative neurocognitive impairment occurring weeks to months after surgery (POND). With the acceleration of the aging process of Chinese social population, the frequency of surgical treatment for elderly inpatients has also increased, and the elderly patients have postoperative sleep disorders, and POCD is relatively common. Surgical patients after surgical trauma, the body inflammation, sympathetic excitation and endocrine disorders, make postoperative sleep structure or pattern change, often lead to postoperative sleep disorders (PSD) , the main performance for patients with postoperative complaint difficult to enter and maintain sleep, frequent nightmares, total sleep quantity and quality reduction, etc. PSD is not only the most common manifestation of postoperative brain dysfunction, but also an important risk factor for inducing postoperative fatigue, postoperative hyperalgesia, metabolic dysfunction, and cardiovascular and cerebrovascular diseases. Moreover, it is considered to promote the development of postoperative delusion. At present, the common mode of general anesthesia is still mainly opioids, and opioids are an important part of general anesthesia and perioperative analgesia. Perioperative use of opioids is not only associated with adverse effects such as postoperative nausea and vomiting, excessive sedation, and ileus, but also leads to the occurrence of postoperative hypoxemia, hyperalgesia and postoperative chronic pain, and cognitive impairment. Therefore, the Association of Accelerated Rehabilitation Surgery indicates that the use of a multimodal analgesic regimen during the perioperative period reduces pain and reduces opioid-related adverse effects, and that opioid-free anesthesia ( OFA) is used in clinical work. At present, most clinical studies of OFA focus on adults aged 18-65 or 18 years old, and few studies focus OFA solely on the elderly population to observe its application effect. Therefore, it is necessary to conduct clinical studies to observe postoperative recovery in elderly patients with different types of anesthetics, investigate the incidence and severity of POCD, and determine the efficacy and safety of each anesthetic agent.

Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom-01B)

single-center, randomized, cross over, double-blind, placebo controlled intervention study

Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women

This clinical study aims to compare the effects of time-restricted eating and a personalized energy-restricted diet on anthropometric measurements, body composition, biochemical parameters, blood pressure, handgrip strength, menopausal symptoms, and sleep quality in obese postmenopausal women. The study is a 12-week, open-label, controlled, parallel-group clinical trial with a quasi-randomized allocation design. The coordinating center is the Department of Internal Medicine, Faculty of Medicine, Gazi University, and the study will be conducted at the Internal Medicine Outpatient Clinic of Cihanbeyli State Hospital in Konya, Türkiye. A total of 40 postmenopausal women are planned to participate, with 20 participants in each group. Participants will undergo an initial medical examination and baseline assessments, including demographic and health information, dietary habits, menopausal symptoms, sleep quality, physical activity, and dietary intake. Anthropometric measurements, body composition, handgrip strength, blood pressure, and biochemical parameters will also be assessed. Participants in the intervention group will follow a time-restricted eating schedule in which they will consume food within an 8-hour daily eating window and fast for 16 hours. The eating window will begin between 8:00 AM and 12:00 PM and will be determined by the participant. During the fasting period, water, unsweetened tea, plain coffee, and plain mineral water will be permitted. Participants in the control group will follow a personalized energy-restricted diet providing approximately 25% less energy than their estimated energy requirements. The diet will be planned according to menopausal nutrition recommendations and individual preferences. Dietary intake will be monitored every 2 weeks. Anthropometric measurements, blood pressure, and handgrip strength will be assessed every 4 weeks. All baseline assessments will be repeated after the 12-week intervention period. The study hypothesis is that time-restricted eating will result in greater improvements than the personalized energy-restricted diet in anthropometric measurements and body composition, biochemical parameters, blood pressure, handgrip strength, menopausal symptoms, and sleep quality in obese postmenopausal women.

Sleep Quality and Frailty Among People Living With HIV

With effective antiretroviral therapy (ART), people living with HIV (PLWH) are living longer and are increasingly experiencing aging-related conditions such as frailty and sleep problems. However, most frailty research has focused on the general older population, and little is known about how sleep relates to physical and oral frailty in PLWH. This case-control study compares sleep disturbance, physical frailty, and oral hypofunction between adults living with HIV receiving ART and sex-matched HIV-negative pre-exposure prophylaxis (PrEP) users recruited from an infectious disease outpatient clinic at a medical center in southern Taiwan. The study also examines whether sleep disturbance (insomnia severity and daytime sleepiness) is associated with physical frailty and oral hypofunction, whether physical frailty represents an indirect pathway between sleep disturbance and oral hypofunction, and the roles of ART and serum Galectin-3 levels in predicting frailty among PLWH.

Acu-TENS to Improve the Sleep Quality in People With Stroke

Post-stroke sleep disorder and motor/cognitive dysfunction are common complications that affect the quality of life of older patients. The proposed study investigates the effects of an acupuncture-like method applied to six bilateral acupoints on sleep quality, motor function and cognition in older adults with chronic stroke. The study will be a single-blind (i.e., only patients will be blinded about the research purpose) randomized controlled trial (i.e., patients receiving the treatment is chosen at random) with a pre-mid-post follow-up design and involve two parallel groups of post-stroke survivors (aged \> 55 years) diagnosed with insomnia. Participants will be randomly allocated in a 1:1 radio to two independent groups, i.e., a treatment group or placebo group, namely a transcutaneous electrical nerve stimulation placed on acupoints (Acu-TENS) or a placebo group. The Acu-TENS group will receive a 6-week treatment that includes a 30-minute Acu-TENS + sleep hygiene program (SHP) twice a week. The placebo group will receive sham Acu-TENS (i.e., devices with the electrical circuit disconnected) + SHP with the same frequency as the Acu-TENS group. The selected acupoints will be bilateral Hegu (LI4), Quchi (LI11), Neiguan (PC6), Shenmen (HT7) on the arm and Sanyinjiao (SP6) and Zusanli (ST36) on the lower limb. The study's primary outcomes will be sleep quality measured by the device of ActiGraph and the self-report survey. The secondary outcomes will be motor function, measured by physical performance tests, cognition, measured by computer battery, and quality of life, measured by the self-report survey. All outcomes will be measured at the baseline assessment (before the treatment), mid-term assessment (after the three weeks treatment), post-treatment assessment (after the six-week treatment), and follow-up assessment (two weeks after the treatment ended). It is hypothesized that the Acu-TENS + SHP treatment will better alleviate insomnia, improve cognition and motor function in participants than the sham Acu-TENS + SHP treatment.

Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.

This study aims to verify the efficacy/effectiveness of treatment with transcranial direct current stimulation (TDCS) in patients with Long Covid who experience headaches, migraines, and chronic pain, such as arthralgia and myalgia, as well as sleep problems. Transcranial direct current stimulation is used in the field of Physiotherapy and Rehabilitation, with results that have proven to be effective for treating patients suffering from symptoms like migraines, headaches, chronic pain, fibromyalgia, or chronic neuropathic pain and insomnia. As you can see, in the case of patients with Long Covid, we find several of these symptoms, so it is suggested that if transcranial direct current therapy (TDCS) gives such good results in relieving these symptoms, why couldn't it give such good results and help just as much in patients with Long Covid, since many of the symptoms are the same, even if the origin or cause is different.

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

StandUPTV Habits: Feasibility Trial for Maintaining Reductions in Sedentary Screen Time

Our goal in this study is to further refine StandUPTV, an application designed to reduce SST in adults in our first study (ASU IRB # STUDY00012109), for the StandUPTV Habits program. This program aims to establish a non-sedentary habit triggered by an alert from the StandUPTV application after participants engage in approximately 30 minutes of SST in the evening.

Multiple Sclerosis Severity and Caregiver Health Outcomes

This cross-sectional observational study aims to investigate the associations between multiple sclerosis (MS) severity and caregivers' sleep quality, physical activity, body awareness, perceived stress, and caregiver burden. A total of 68 caregivers of patients with MS will be recruited from Başkent University Hospital. MS severity will be assessed using the Expanded Disability Status Scale (EDSS), while caregiver health outcomes will be evaluated using validated questionnaires. The findings are expected to provide insight into the multidimensional impact of MS severity on caregiver health and well-being.

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.

Association Between Sleep Quality and Self-Care in Heart Failure Patients

The research will be conducted as a prospective and relational study to longitudinally investigate the effect of sleep quality on self-care in patients with heart failure (HF) and to evaluate the relationship between self-care, sleep quality, and cognitive functions. The sample size was calculated using the multiple linear regression model with the G\*Power Version 3.1 program. Based on a medium effect size of 0.15, an alpha of 0.05, a power of 0.95, and 18 predictors, the sample size was determined to be 188. Considering a potential dropout rate of 10%, it was decided to complete the study with a minimum of 207 participants. Data will be collected from patients who apply to the Dokuz Eylül University Cardiology Outpatient Clinic and meet the inclusion criteria. After signing the informed consent form, participants will be followed up at baseline, the 1st month, the 3rd month, and the 6th month by telephone. The Statistical Package for Social Sciences (SPSS) 24.0 will be used to analyze the numerical data of the research. Descriptive statistics, including number, percentage, mean, and standard deviation, as well as inferential statistics such as the χ2 test, t-test for independent groups, and multiple linear regression, will be employed in the data analysis.