Sleep Quality

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.

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.

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.

This study aims to investigate the effects of preoperative white noise and pink noise interventions on sleep quality, anxiety, postoperative pain, nausea, and physiological parameters in patients undergoing elective total hip arthroplasty (THA) or total knee arthroplasty (TKA). A total of 165 adult patients will be randomly allocated into three equal groups: a white noise group, a pink noise group, and a control group (55 participants per group). On the evening prior to surgery (around 10:00 PM), participants in the experimental groups will listen to standardized white noise or pink noise at 45-50 dB for 30 minutes via over-ear, active noise-cancelling headphones. Participants in the control group will receive routine perioperative care without any auditory intervention. Data regarding sleep quality, anxiety levels, pain intensity, nausea, and hemodynamics (blood pressure, heart rate, respiratory rate, and oxygen saturation) will be collected using validated scales and physiological monitoring before and after the intervention as well as in the postoperative period (at 0, 12, and 24 hours).

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.

Poor sleep quality and short sleep duration may be a mechanistic component of cognitive impairment in older adults, associated with a decline in brain-derived neurotrophic factor. Increasing the availability of nicotinamide adenine dinucleotide (NAD+) with supplementation of its precursor, nicotinamide riboside (NR), a form of vitamin B3 may increase the expression of brain-derived neurotrophic factor. This study proposes to examine the benefits of NR supplementation on sleep and cognitive function in older adults with comprehensive subjective and objective measures and to explore its impacts on serum brain-derived neurotrophic factor.

The goal of this clinical study is to learn if using a special pillow placed behind the shoulder can help to reduce pain and improve sleep for patients after surgery to repair a torn rotator cuff. The main questions it aims to answer are: * Do patients who choose to use the posterior shoulder pillow have lower pain levels after surgery? * Do these patients report better sleep quality during recovery? * How safe and comfortable is the pillow for patients to use? Researchers will compare patients who use the pillow to those who do not use it to see if there is a difference in their recovery. Participants will: * Be asked about their willingness to use the pillow. Their treatment and recovery plan will be decided together with their doctor. * Be asked to rate their pain and sleep quality several times after surgery: at 1 week, 2 weeks, 4 weeks, and 6 weeks. * Have their shoulder function assessed by a clinician at 2, 4, and 6 weeks after surgery. * Receive a standard MRI scan before and 6 weeks after surgery as part of their regular medical care to check on healing.

This observational behavioural study examines whether individual differences in sleep quality, sleep timing, and chronotype are associated with prosocial allocation decisions in adults. Participants will complete self-report sleep and circadian questionnaires, including the Pittsburgh Sleep Quality Index and the Munich Chronotype Questionnaire, a 7-day sleep diary, and a brief computer-based Dictator Game allocation task. The study does not involve sleep deprivation, sleep restriction, treatment, clinical diagnosis, medication, or medical devices. Participants will not be asked to change their sleep schedule. The Dictator Game decisions are hypothetical and do not affect participants' compensation. The study is intended to describe associations between naturally occurring sleep-related individual differences and behavioural allocation choices, not to diagnose or treat sleep or mental health conditions.

The purpose of this study is to evaluate the effects of KA-EX supplementation on recovery parameters in elite young football players. Athletes from the Udine Primavera team will be randomly assigned to receive either the KA-EX supplement or a sensory-matched placebo immediately following their training sessions for a period of two months. The researchers will monitor heart rate variability (HRV) and sleep quality using Garmin wearable devices, and assess changes in body composition using Dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA). The goal of the study is to determine if post-training KA-EX administration improves physiological recovery, sleep quality, and physical readiness in high-performance athletes during a competitive season.

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.

Individuals living with an intestinal or urinary stoma frequently report disturbed sleep. Night-time pouch filling and leakage, odour and gas concerns, restricted sleeping positions, peristomal skin problems and the need for night-time pouch emptying interrupt sleep, while anxiety, depressive symptoms, altered body image and social withdrawal add to this burden. Poor sleep in this population has been associated with reduced quality of life and impaired daytime functioning; however, most of the available evidence is cross-sectional and based exclusively on self-reported measures. Nursing interventions that specifically target sleep in people with a stoma are few, generally consist of a single component, and have rarely been tested in randomised designs or alongside objective sleep measurement. This trial evaluates an Artificial Intelligence-Supported Multimodal Nursing Intervention (AI-MNI) developed to improve sleep quality in adults living with a stoma. The intervention was designed in line with the Medical Research Council framework for complex interventions and is delivered over four weeks through the institutional web-based learning management system. It comprises five structured modules: stoma care and night-time comfort; sleep hygiene and night routine; psychological wellbeing and relaxation techniques; body image, self-esteem and sexual health; and physical activity and daily energy management. Each module combines written material, video, visual guides, checklists and short knowledge checks. A rule-based chatbot embedded in the platform supports participants by prioritising content, suggesting review of relevant material and responding to questions within a pre-approved educational content set; it does not provide diagnosis, treatment advice or clinical decision support. All content was evaluated for content validity by an expert panel before implementation. The study is a two-arm, parallel-group randomised controlled trial conducted in the stomatherapy unit of a university hospital. Forty-two adults (21 per group) with a colostomy, ileostomy or urostomy of at least three months' duration and a Pittsburgh Sleep Quality Index (PSQI) global score greater than 5 will be allocated in a 1:1 ratio using permuted block randomisation with variable block sizes, stratified by sex and stoma type. Allocation is concealed through a central, password-protected web-based system, and statistical analyses are performed by a statistician blinded to group codes. The intervention group receives AI-MNI in addition to standard care; the control group receives standard care alone and is offered access to the programme after the final assessment (delayed-access design). Assessments are conducted at baseline (T0), at the first month (T1) and at the third month (T2). The primary outcome is the change in PSQI global score from baseline to the first month, with the third-month assessment used to examine whether any improvement is maintained. Secondary outcomes are objective sleep parameters (total sleep time, sleep efficiency, sleep stage indicators and sleep onset latency) recorded with a consumer wrist-worn device on three consecutive nights at each assessment point, and stoma-specific quality of life. Module completion, session duration and level of interaction are reported as process outcomes. Analyses follow the intention-to-treat principle and are based primarily on linear mixed-effects models.

This clinical trial will study the effects of Ashwagandha (Withania somnifera), a natural plant extract, on physical and mental health in adult men. Ashwagandha is known for its potential to reduce stress, support hormonal balance and improve sleep and physical performance. The study will explore how taking Ashwagandha for 12 weeks, with resistance training, affects various health markers such as stress hormones, brain function, muscle strength, body composition, sleep quality, and cognitive abilities. Participants will be healthy, non-smoking men aged 25-40, with regular resistance training experience. They will be randomly assigned to one of two groups: (1) weight training + Ashwagandha, (2) weight training + placebo. The study is double-blinded, meaning neither participants nor researchers will know who is receiving Ashwagandha or placebo. Participants will: * Take Ashwagandha or a placebo every day for 12 weeks * Train in the gym three times a week Researchers will assess changes in blood markers (like cortisol, testosterone and BDNF - brain-derived neurotrophic factor), physical performance (muscle strength and endurance), sleep quality, stress perception and cognitive function before and after the 12-week period. The goal is to better understand how Ashwagandha works.

The main goal of this study is to evaluate the "SIESTA" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health. The main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants? Participants randomized to the SIESTA intervention will: 1. Attend 4 remotely administered group sleep hygiene education sessions 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality. Participants randomized to the Child Health Control condition will: 1. Attend 4 remotely administered group sessions covering general health topics 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality. A secondary goal of the study is to conduct a process evaluation to prepare for future larger scale use of the intervention in other urban school settings. This will entail assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the program through several methods, such as by conducting in-depth interviews with research participants and their parents/guardians, as well as school staff and by looking at rates of participation in the program.

The goal of this clinical trial is to learn if AB-free kava works to improve mobility and physical function in older adults with sleep difficulties. It will also learn about the safety of AB-free kava. The main questions it aims to answer are: * Does AB-free kava improve physical function and/or mobility? * Does AB-free kava effect sleep, stress, or cellular signaling? Researchers will compare AB-free kava to a placebo (a look-alike substance that contains no drug) to see if AB-free kava works to improve mobility and physical functioning.

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.

Coronary artery bypass graft (CABG) surgery is an effective treatment for coronary artery disease; however, sleep disturbances and delirium are common during the postoperative period and may adversely affect recovery. Environmental factors, particularly light exposure, can disrupt the sleep-wake cycle and contribute to poor sleep quality. Eye masks offer a simple, safe, and non-pharmacological method of reducing light exposure and supporting sleep. This study aims to determine the effect of eye mask use on sleep quality and delirium levels in patients following CABG surgery.

This study aims to explore the relationships between frailty, daily physical activity, sleep quality, and Traditional Chinese Medicine (TCM) constitutions among older adults in Taiwan. In the trial phase, a randomized controlled trial will be conducted specifically for pre-frail older adults. Participants will be randomly assigned to either the exercise training group (Vivifrail program) or the integrated group combining exercise with daytime and sleep-improving acupoint stimulation. The study evaluates the combined efficacy of these non-invasive interventions on reducing frailty severity, improving sleep, and enhancing daily physical functions.

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.

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

This is a decentralized, single-arm, open-label clinical trial evaluating the effects of the Edge+Ease PM+AM dietary supplement system on sleep quality, mood, mental clarity, focus, and digestive comfort in 35 generally healthy adults aged 18-65 years over 12 weeks of daily use. Participants will take the Edge+Ease PM product (one serving of powder mixed in approximately 150-250 mL water) in the evening approximately 60-90 minutes before bedtime, and the Edge+Ease AM product (two capsules) in the morning with food. All study activities are conducted remotely via the Citruslabs platform. Participants will complete questionnaires at Baseline, Week 4, Week 8, and Week 12, and will wear a Fitbit continuously beginning 7 days before product use through the end of the 12-week intervention period to provide objective sleep data.

This study will test whether a magnesium supplement (Magnesium Breakthrough) improves sleep quality and mood in women ages 35 to 60 who have poor sleep but no diagnosed sleep disorder. Participants will take the magnesium supplement for two weeks and a matched placebo for two weeks, in random order, separated by a one-week washout period. Neither participants nor study staff will know which product is being taken during each period. Throughout the study, participants will wear an Oura Ring to track sleep patterns and will complete short daily and biweekly questionnaires about their sleep, mood, stress, and energy levels. The main measure of interest is change in sleep quality, assessed using a validated sleep questionnaire (the Pittsburgh Sleep Quality Index). The study will also look at effects on mood, stress, and objective sleep measures from the Oura Ring. All study activities - screening, consent, and data collection - are conducted remotely, so participants can take part from anywhere in the United States.

This study is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study.

The goal of this observational study is to learn if there are potential digital and plasma-based biomarkers that could help detect, predict, and prognosticate delirium in older adult patients who are admitted to the intensive care unit (ICU). The main question DELTA aims to answer is: Can digital biometrics predict and detect delirium in older adult ICU patients? Do biomarkers of neurodegeneration fluctuate in ICU patients in such a way that delrium could potentially be predicted? Participants admitted o the ICU will wear a digital device to collect biometric data and will have serial plasma samples collected during ICU admission and patients will be also assessed for delirium daily by study staff.

The goal of this clinical trial is to learn if ZenRest™ (Lotus Seed \& Rice Germ Extract Blend) can help improve sleep quality in menopausal women aged 40-65 with mild-to-moderate sleep complaints. The main questions it aims to answer are: * Does taking ZenRest™ daily improve subjective, participant-reported sleep quality compared to a placebo? * Does ZenRest™ improve objective sleep metrics, specifically sleep efficiency, when monitored via an Oura Ring wearable device? * Does the extract improve secondary sleep and lifestyle factors, such as insomnia severity, daytime sleepiness, and vitality? Researchers will compare ZenRest™ to a placebo (a look-alike capsule that contains no active ingredients) to see if the botanical blend has a measurable effect on sleep quality.

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