3,325 Clinical Trials for Various Conditions
Our goal is to observational study is to determine feasibility of partial sleep restriction in individuals with CLBP+I and correlation findings with features of central sensitization. * Identify feasibility of sleep restriction protocol * Identify correlation between less sleep and central sensitization Sleep will be monitored for 2 weeks (baseline sleep monitoring period). Then participants will be asked to restrict their sleep to 80% of their normal sleep duration for 5 nights (sleep restriction period). Then sleep will be monitored again for 2 weeks (sleep recovery period).
The aim of this study is to design a sleep and mindfulness intervention to improve sleep, quality of life, and cognitive function among older adults.
Suicide is the second leading cause of death in youth, and recent statistics indicate disproportionate risk for suicidal behavior among Black youth. Despite this, few interventions effectively prevent youth suicidal thoughts and behaviors (STB). Sleep difficulties may be a particularly promising target for youth STB prevention efforts. To date, no intervention targeting sleep difficulties have been examined among youth at-risk for STBs nor tailored to Black youth; this research is critical for maximizing intervention acceptability and impact. The Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence-based, modularized intervention that targets a range of sleep and circadian difficulties, making it especially well-suited for treating adolescent sleep. Delivery of this intervention will be through telehealth with a Sleep Therapist. Youth will wear an actigraphy watch that monitors sleep and will complete daily sleep diaries via smartphone or email; sleep feedback reports of sleep diary and actigraphy data are available on demand after completing a diary entry. The adolescents will also wear bright light glasses in the morning and blue light blocking glasses in the evening. Adolescents will also attend weekly or biweekly sessions with a Sleep Therapist. The Sleep Therapist will review sleep feedback generated from actigraph and sleep diary data with adolescents during sessions. In the Sleep Feedback alone intervention, adolescents will wear an actigraphy watch and complete daily diaries; they are able to view their sleep feedback on demand through user-friendly graphs of naturalistic objective and subjective sleep data.
The goal of this interventional study is to differentiate the effects of an acute partial sleep deprivation intervention on markers of cardiovascular health, cardio-autonomic function, physical and cognitive performance, as well as overall wellbeing in active vs sedentary individuals. The main aims of the project are: * To differentiate the effects of partial sleep deprivation on central hemodynamics (i.e., central blood pressure and arterial stiffness) in active vs sedentary individuals. * To differentiate the effects of partial sleep deprivation on physical (i.e., handgrip strength and reactive strength index) and cognitive performance (i.e., reaction time and impulse control) in active vs sedentary individuals. * To differentiate the effects of partial sleep deprivation on overall wellbeing (i.e., cardio-autonomic function, inflammation levels, and psychological mood states) in active vs sedentary individuals. Participants will be divided into two groups based on aerobic activity level - active or sedentary - and assessed for markers of cardiovascular health, cardio-autonomic function, physical and cognitive performance, as well as overall wellbeing before and after three days of normal sleep and three days of partially deprived sleep (i.e., 30% reduction in total time in bed).
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 investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.
This is a randomized, double-blind, placebo-controlled, 5-arm parallel-group study to evaluate the effects of 4 nutritional supplements on sleep over a 12 week period in healthy U.S. adults.
This study will examine whether a combination of breathing training during wake and targeted reactivation of the training during sleep can induce breathing changes during sleep and subsequent cognitive benefits during wake. Participants with obstructive sleep apnea (who have not yet been treated for sleep apnea) will be recruited. Participants will engage in breath training for one week in their own homes and to record their sleep at home using commercially available mobile devices and subsequently have their sleep monitored for one night of polysomnography recordings plus targeted reactivation in a laboratory setting.
The study team is conducting a study to see if Magnesium-L-Threonate (MgT) can help improve how well participants sleep and reduce pain after total joint replacement surgery
The purpose of this study is to evaluate the efficacy and superiority of a botanical based sleep product on sleep quality as compared to melatonin, among healthy female participants.
The purpose of this clinical trial is to assess the effects of a supplement combination on measures of sleep quality and stress in healthy adults.
Concussions are incredibly common, and often result in severe and long lasting symptoms, including, but not limited to, sleep deprivation and emotion dysregulation. This study aims to demonstrate the therapeutic benefits of sleep extension (napping) on emotion regulation in individuals after they sustain a concussion. Thus, sleep extension may be a cost-effective, low risk, supplemental treatment for those with emotion dysregulation following a concussion. The main questions it aims to answer are: 1. Is a nap an effective way to improve emotion regulation in individuals with a concussion? 2. Does a nap reduce the required executive resources necessary to regulate emotions in individuals with a concussion?
The goal of this study is to establish the feasibility, tolerability, and preliminary efficacy of sleep-state transcranial magnetic stimulation (TMS) for enhancing plasticity in depression treatment.
The goal of this study is to compare two different approaches to help families with children 6-11 years enhance nighttime sleep: 1) working one-on-one with a nurse to learn effective behavioral strategies to try to improve children's sleep or 2) receiving education on a good night's sleep and its benefits. Participating families will meet with a nurse 6 times or receive 6 educational handouts. Participating families will also complete three assessments (start of the study, 2 months and 6 months) during which study questionnaires will be completed, participating children will wear devices that assess sleep and physical activity, participating families will report on what the child ate on two separate days and will be measured for height and weight.
Attention deficit/hyperactivity disorder (ADHD) can present differently in individuals, with some individuals having difficulty with attentional control, hyperactivity, impulsivity, emotion dysregulation, and/or neurobehavioral functioning. The factors contributing to these different presentations remain unclear, but altered patterns of physical activity, sleep, and circadian rest/activity rhythms may play a key role. The goal of this study is to leverage wearable technology (i.e., a wristband) to investigate the relationships between physical activity during the day, sleep patterns and disturbances, and 24-hour circadian rest/activity rhythms with differences in ADHD symptoms, emotion dysregulation, and related brain and behavioral features of attention-deficit/hyperactivity disorder (ADHD). The investigators hope this study will help improve assessment and intervention for individuals with ADHD by understanding how these factors relate to ADHD symptom expression and associated brain differences in ADHD. Participants taking stimulant medication must withhold stimulant medication 24 hours before their research appointment and the morning of their research appointment. Stimulant medication may be restarted after the appointment is complete. Participation in this study will require children to complete an initial 2-hour research appointment, two (2) weeks of activity and sleep monitoring at home using a wearable wristband and answering questions sent to a smartphone, and a second 4-hour research appointment after the 2-week period. During the first research appointment, children will complete a cognitive assessment and a practice magnetic resonance imaging (MRI) scan. Parents/legal guardians will participate in the 30-45-minute sleep device training session with one of the research staff. During the two weeks of activity/sleep monitoring at home, parents and children will answer questions about their sleep routine, ADHD symptoms, and emotional responding each morning and evening. Parents will be asked to install a questionnaire application on their smartphone. A prompt will be sent to their smartphone multiple times per day reminding parents to complete the brief assessment. After the 2-week period, children will complete a 4-hour research appointment. During this research appointment, children will complete a 60-minute MRI scan and computer-based activities that assess cognitive skills, reward-based decision-making, and frustration tolerance. At the end of the research appointment, children will return the device to our research team. Parents may delete the questionnaire application from their phone at the end of the research appointment. Participation will also require parents/legal guardians to complete questionnaires about their child. Questionnaires will be provided to the primary caregiver by email or at the beginning of their child's first research appointment. Parents agree to complete and return the questionnaires within one month of their child's research appointment. Parents may be provided with additional questionnaires to give to their child's primary schoolteacher. This information is collected to better understand children's abilities, behavior, strengths, and weaknesses. There are minimal risks associated with this study. Risks include fatigue, boredom, and mild discomfort. There is no cost to participating in this study. There is no direct benefit to participants for participating in this study.
The study aims to evaluate the accuracy of sleep trackers in children aged 2 to less than 18 years. Children undergoing polysomnography, the gold standard for assessing sleep quality and duration, at Arkansas Children's Hospital may be eligible to participate. Participants will be asked to wear sleep trackers on the day of their sleep test. The data collected from the sleep trackers will be compared with the polysomnography results to determine the devices' accuracy.
Aim 1 of the proposed project will be to adapt the virtual Mindfulness-Based Therapy for Insomnia (MBTI) for individuals with Down syndrome (DS). The investigators will work closely with a community advisory board consisting of individuals with DS, their caregivers, and clinicians specializing in DS and sleep medicine to ensure that the intervention protocol is relevant and appropriate for young people with DS (age 12 and older). Planned adaptations include 1) utilization of visual aids and videos to increase engagement and reinforce mindfulness concepts and practices; 2) shortened meditation practices to accommodate concentration limits of individuals with DS; 3) caregiver involvement reflecting the important role of caregivers in daily functioning of individuals with DS; 4) adapted homework to cater to the learning styles of individuals with DS; 5) daily reminders to encourage regular practice and reinforce the importance of consistency; and 6) modified session structure to ensure that participants are able to discuss their experiences and refine their mindfulness practice. During the first 6 months of the project, the investigators will meet monthly with the community advisory board and use an iterative process to develop detailed intervention protocol for a virtual MBTI suitable for young people with DS. Aim 2 of the project will be to pilot test the efficacy of the virtual MBTI for young people with DS. In the second half of the one-year project, the investigators will conduct a pilot randomized clinical trial (RCT) of the intervention developed in Aim 1. This project will compare the effectiveness of Mindfulness Based Therapy for Insomnia (MBTI) and Brief Behavioral Therapy for Insomnia (BBTI) for young people with Down syndrome (DS). The interventions will be compared on their impact on improving sleep problems, quality of life, and functional outcomes. This project will also test if targeting the sleep of the caregiver in addition to the individual with Down syndrome has any effect on the outcomes.
The goal of this clinical trial is to learn if having a 4-week heartfulness meditation program in a healthcare organization would 1. decrease burnout 2. improve sleep and work engagement. Researchers will compare : intervention group : participating in 4 weeks of Heartfulness Meditation with control group: receiving no intervention Responses to the Utrecht Work Engagement Scale (UWES), Bergen Insomnia Scale (BIS) and two burnout questions will be compared between the study groups at the beginning and end of the intervention period.
Nearly 50% of older adults complain of poor habitual sleep, and in many cases the underlying reason remains undiagnosed or unknown. Meanwhile, observational data suggest that bedroom temperature significantly influences sleep quality in community-dwelling older adults, including those without financial constraints that limit the use of heating and cooling. These individuals often struggle to maintain an optimal bedroom temperature, either due to impaired motor function and cognitive abilities, and/or a lack of awareness about how temperature affects their sleep. Therefore, for a non-trivial portion of older adults, optimizing the bedroom temperature presents an exciting and untapped opportunity to improve sleep without substantial cost, burden, and side effects. The intervention, biologically adaptive control of bedroom temperature, uses wearable health trackers (e.g., a Garmin watch) and smart thermostats to automate and personalize bedroom temperature control, tailoring it to each person's unique physiology and context. Initially, individuals will be monitored in their home to determine each person's specific temperature range that promotes sleep quality, as measured by the wearable device. After the initial monitoring, the smart thermostat will maintain bedroom temperature within the optimal range for sleep for as long as the individual uses the intervention. The primary purpose of this project is to test the feasibility of biologically adaptive control of bedroom temperature as an intervention to improve sleep in older adults and gather preliminary data to facilitate sample size calculations for a definitive trial. 20 Older adults, aged 65 and above, will be enrolled and their bedrooms bedrooms will be equipped with smart thermostats. The first aim focuses on assessing the feasibility of the intervention. This includes evaluating participant recruitment and retention, the acceptability of temperature adjustments (tracked through the number of temperature overrides by participants), and the self-reported likelihood of future use. The second aim involves analyzing the mean and variance of sleep outcomes during observation and intervention phases (separately for each group), examining the degree to which they vary with temperature variations and behavioral adaptations.
This study aims to explore the impact of supplementation with CARDIO® whole salmon oil capsules on healthy adult participants with sleep disruption related to particulate matter pollution. The trial will employ a decentralized approach enabled by modern technology and wearables to measure sleep quantity and quality. Validated patient reported outcome (PRO) measures will be employed to measure the impact on cough and the subjective assessment of sleep quality and wellbeing. After a two week run-in period, subjects will be randomized to OmeGo at either 2g or 4g daily for 8 weeks. Final assessment will be at week 10.
The purpose of this study is to examine the effect that melatonin lotion has on sleep quality, the nervous system, and mental health. Melatonin is a hormone secreted by the brain that regulates sleep and might improve depression and anxiety symptoms. The goal is to determine whether melatonin in lotion form is an effective treatment for young adults with inadequate sleep and might improve mental health. Participants will fill out surveys, wear an actigraph (a wrist-worn device that measures sleep), wear a heart rate monitor (a strap worn around one's chest), and provide nightly saliva samples during treatment weeks. In one of the two treatment weeks, participants will receive a lotion that contains melatonin. During the other week they will receive a control treatment that will be lotion with no melatonin, and there will be a week in between with no treatment at all.
The goal of this study is to learn how cannabis use and discontinuation affect sleep, circadian rhythms, and sensitivity to light. The main questions it aims to answer are: 1. Does cannabis use and discontinuation impact sleep drive? 2. Does cannabis use and discontinuation impact light sensitivity and circadian phase?
Insufficient and disrupted sleep are rarely addressed in expectant and new mothers, despite evidence that disturbed sleep is a modifiable risk factor for negative health outcomes for mothers and their children. In this study the investigators will adapt, refine, and pilot test the implementation of a behavioral sleep intervention consisting of short videos designed to accompany a free behavioral sleep app. In Phase 1, the investigators will develop and refine the intervention with input from direct care workers who serve at-risk perinatal women. In Phase 2, direct care workers will deploy the training to expectant mothers with sleep concerns and the investigators will assess the reach, effectiveness, adoption, implementation, and maintenance of this scalable, efficient intervention to improve sleep.
The goal of this study is to learn the effect of a telehealth mindfulness meditation program on sleep quality and anxiety in individuals with brain injury living in the community. The main questions it aims to answer are: * Does an eight-session mindfulness meditation program change sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in individuals with acquired brain injury? * Does an eight-session mindfulness meditation program change anxiety levels as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form in individuals with acquired brain injury? Participants will: * Complete eight sessions of mindfulness meditation over 4 to 5 weeks * Complete two mindfulness meditation sessions per week. * Complete two additional sessions for pre- and post-test measurements.
This study investigates the relationship between the noradrenergic (NA) system, sleep quality, and cognitive function in older adults with insomnia - a population at elevated risk for Alzheimer's disease-related dementias (ADRD) - compared to age and sex matched controls with normal sleep. The study characterizes NA function through multiple approaches: measuring 24-hour plasma levels of norepinephrine (NE) and its brain metabolite 3-methoxy-4-hydroxyphenylglycol (MHPG); evaluating central NA system response using the clonidine suppression test (a presynaptic α2 adrenoreceptor agonist that reduces locus coeruleus NA activity; and employing pupillometry as a non-invasive marker of autonomic function. To explore NA function's mechanistic role in insomnia, the study uses an intervention with bright light exposure to enhance daytime NA activity, with the goal of improving both sleep quality and cognitive performance.
Obstructive Sleep Apnea (OSA) is a common medical disorder that is associated with reduced quality of life and higher risk of cardiovascular disease. Treatments for OSA and limited and not well tolerated. The investigator's lab has shown that a low carbohydrate, high fat ketogenic diet (KD) can reduce OSA severity. Since it can be challenging to adhere to a ketogenic diet, the investigators propose that ingesting exogenous ketones can be an alternative method to improve OSA. Specifically the investigators will examine the effect of taking a commercially available product (Ketone-IQ) at bedtime on overnight ketones and sleep quality. The investigators will also examine the effect of Ketone-IQ on sleep apnea severity, compared to placebo. This project will examine the the preliminary efficacy of ingesting exogenous ketones before sleep on sleep apnea.
The goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia.
The goal of this interventional study is to learn if a digital sleep extension intervention can improve sleep and mood in young urban adults with mood symptoms. The main questions it aims to answer are: Will this intervention improve sleep? Will this intervention improve mood? Does the effect of this intervention change based on environmental factors like noise and light pollution? Researchers will compare participants receiving the sleep intervention to participants receiving a "general healthy living" intervention to see if outcome are different across groups. Participants will: * receive 6 weeks of brief once weekly telephone coaching and read once weekly educational content * have their sleep monitored daily with a FitBit and Somnofy sleep device and during the 6-week intervention period * respond to questionnaires at the start of the intervention, halfway through the intervention, at the end of the intervention, and finally 4 weeks after completing the intervention
Sleep is often a challenge for nightshift workers because their work and sleep schedules are inverted. Sleep is commonly measured using actigraphy, which is the standard measure of objective sleep in the general population; however, this method has substantial limitations for nightshift workers because the standard legacy algorithms only correctly identify 50.3% of daytime sleep. This significantly reduces the validity for nightshift workers. The purpose of this study is to test a novel method to expand actigraphy by using 1) a multi-sensor approach that 2) uses machine learning (ML) algorithms to increase the accuracy of detecting daytime sleep.
Repetitive transcranial magnetic stimulation (rTMS) has shown to be a promising technique for improving insomnia symptoms and sleep quality. However, the impact of circadian rhythmicity on rTMS sessions and its potential influence on insomnia therapy remains unclear. Moreover, the effect of rTMS on objective sleep parameters is not fully established. The objective of this pilot study is to establish key feasibility and preliminary data that would be used for an R-level grant application focused on optimizing rTMS therapy for insomnia. The investigators will acquire feasibility data from ten adults with Insomnia disorder. Participants will receive ten sessions rTMS over two weeks, either in the morning or evening. Sleep parameters will be assessed before, during, and after completion of rTMS and brain cortical excitability will be collected before rTMS treatment. The investigators aim to 1) evaluate the impact of circadian timing of rTMS sessions on subjective and objective sleep outcomes, 2) assess the time course of improvements in sleep outcomes, and 3) examine the association between sleep outcomes and cortical excitability. The overarching goal of this work is to optimize rTMS therapy for insomnia by investigating the impact of circadian timing on rTMS sessions and assessing potential variations in subjective and objective measures of sleep.