64 Clinical Trials for Various Conditions
This is a research project looking at whether measuring movements or responses to certain questions can help predict suicidal thoughts or actions. This project has two parts: The first part will occur while the participant is receiving hospitalized at the Bedford VA Hospital. It involves wearing a watch-like device on his/her wrist and answering questions or doing tasks to measure mood and other mental health symptoms, and suicidal thoughts. In the second phase, the investigators will call the participant around 12 months after s/he has left the hospital. The investigators will discuss how s/he is doing and if s/he has had suicidal thoughts or made suicidal acts.
A prospective, open-label, and multi-centered feasibility registry.
The purpose of this study is to develop statistical and informatics tools for analyzing and visualizing Actical™ (actigraphy) data linked to fatigue in Sleep Medicine Center patients.
The purpose of this study is to learn how well an instrument called an Actiwatch-2 can determine whether a child is asleep or awake. The Actiwatch-2 (manufactured by Minimitter/Respironics of Bend, Oregon) is the brand name for an actigraphy monitor; that is, a motion sensor that is typically worn on the wrist and looks like a wrist watch. It measures and records the amount of movement a person makes each minute. After being worn overnight, data are transferred from the Actiwatch to a computer, and a program estimates whether a person is awake or asleep by analyzing the recorded movement data. The enrollment target is 80 participants. Although other actigraphy equipment has been used to monitor sleep in children, the Actiwatch-2 has not been validated in the pediatric population.
This study plans to explore whether specially chosen relaxing music can help improve sleep, reduce stress, and prevent burnout in healthcare workers, many of whom are often sleep-deprived. The researchers will measure changes in brain activity, sleep patterns, and self-reported stress levels before, during, and after participants listen to this music. The novel approach includes using advanced brain scanning technology, sleep monitoring devices, and carefully selected music. Ultimately, the aim is to create a scientifically backed music intervention that can be used widely to help healthcare providers get better sleep and manage stress, potentially reducing burnout rates.
Many treatments for prostate cancer can cause significant fatigue and/or problems with memory and concentration. Many treatments for prostate cancer also result in disturbed sleep. Improving sleep may reduce feelings of fatigue and improve memory and concentration. The purpose of this study is to test a wearable device that provides real-time feedback on sleep patterns, instruction on how to improve sleep, and a score that indicates periods of time when fatigue and issues with memory and concentration may be most troublesome. The study also is designed to test a type of treatment (cognitive behavioral therapy for insomnia, CBT-I) that is helpful for people who are experiencing disturbed sleep.
This study plans to learn more about activity levels in children with pulmonary hypertension. Pulmonary hypertension is a condition where the pressure in the lungs is higher than normal. This can affect the person's heart. The purpose of this study is to see if measuring activity in children with pulmonary hypertension and comparing it to activity in children without pulmonary hypertension can give their doctor helpful information on how they are feeling and how their treatment is working.
This is a study to evaluate the effect of voxelotor on daily physical activity and sleep quality, as measured by a wrist-worn device in participants with sickle cell disease (SCD) and chronic moderate anemia.
Sleep disturbance is very common in patients with atopic dermatitis (AD) and is a major factor leading to impaired quality of life. Nocturnal scratching is one of the factors causing sleep disturbance in AD patients. This study aims to develop and validate a digital algorithm for accurately and reliably detecting and quantifying nocturnal scratch behaviors related to AD using wrist actigraphy data. Wrist actigraphy is an investigational device being developed to detect and quantify scratching behaviors in patients with AD. This study will be conducted in 2 sequential stages: In Stage 1, an algorithm will be developed and in Stage 2 the algorithm developed will be validated. Adult healthy volunteers or participants with AD will be enrolled. Approximately 14 healthy volunteers, 14 AD patients with low disease activity and 28 AD patients with high disease activity will be enrolled in the study in 5 sites across the United States. No drug will be administered as a part of this study. Participants enrolled in this study may experience discomfort or inconvenience related to the study procedures. Participants will be enrolled and monitored overnight for two consecutive nights at an inpatient setting at a hospital or clinic. The impact of nocturnal scratching on sleep parameters will be assessed by videography, actigraphy, sleep headband and completing questionnaires.
The purpose of this study is to collect data to validate the step- (actigraphy) and sleep-tracking performance of the Medical Health Tag device developed by Spire Health.
Physical activity is an important factor in understanding how diseases can affect a child. Decreases in physical activity are sometimes the first thing that happens before a child is diagnosed with a disease. When a child sees their doctor, that visit reflects a single point in time. It does not capture how a child feels during the days in between visits to their doctor. This study plans to use special monitors called actigraphs to collect information about physical activity in children with a type of disease called pulmonary hypertension. This study will measure how active these children are and compare their activity to clinical information and to actigraphy measurements in children without pulmonary hypertension.
This study is to determine whether accelerometry can be used to measure physical activity occurring during routine clinical care in a diverse population of patients with medical or surgical critical illness.
To test if usual at home night time sleep duration as measured with activity monitors and questionnaires will predict changes in kidney function as measured by kidney filtration rate and of cardiovascular function as measured by C-reactive protein in the blood. The study will explore the role of decreased sleep time or decreased sleep quality as a non-traditional risk factor for the progression of CKD and for the development of cardiovascular disease in CKD.
This study will assess the feasibility of conducting sleep studies in a clinical research unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy technologies will be compared for evaluating sleep stages and sleep architecture.
We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. In this pilot study, we will test the null hypothesis (Ho) that there are no differences in the sleep quality between patients with orthostatic intolerance and healthy control subjects.
Trauma-related nightmares in Veterans are associated with poor clinical outcomes, greater substance use, and increased risk of suicide. In spite of an urgent need to reduce the burden of trauma-related nightmares, the underlying physiological changes associated with them are poorly understood, and there are no clear evidence-based recommendations for their treatment. Limitations of current assessment procedures represent a barrier to improved care. In-laboratory sleep studies rarely capture nightmares, limiting the knowledge about them and their response to treatment. This study addresses these limitations by using extended, in-home sleep monitoring to capture sleep data associated with nightmare reports in Veterans, and assessing how these features are altered throughout a cognitive-behavioral nightmare treatment. Results from this study will increase understanding of trauma-related nightmares, and advance strategies for personalizing symptom management for Veterans.
This study is testing a program called Maximizing Energy to see if it can help women who have finished breast cancer treatment manage their fatigue. The study has two main goals: 1. Check if the program can be successfully delivered - Researchers will see if women are willing to join and stay in the study, if they follow the program, and if they find it helpful. 2. See if the program works - Researchers will compare Maximizing Energy to a general health education program to see which one helps reduce cancer-related fatigue better. Participant will: 1. Take tests to see if they qualify and to measure their fatigue. 2. Be randomized to receive Maximizing Energy or Health Education Interventions for 6 sessions over the internet 3. After the sessions and again one month later, repeat some tests to see if their fatigue has improved.
The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.
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.
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.
The goal of this study is to test an adapted treatment for teen insomnia in comparison to a waitlist condition. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an intervention that was developed for adults and is sometimes also used for teens. Teens, parents, and health care providers helped to review and adapt CBT-I to form Teen CBT-I. Teen CBT-I includes most of the same content as CBT-I, with some changes to match teen biology and lifestyles. The main questions this clinical trial aims to answer are: * Does Teen CBT-I improve insomnia symptoms in teens? o Researchers will compare Teen CBT-I to the waitlist control condition to see if insomnia symptoms significantly improve in the treatment group. * Do teens and their parents find Teen CBT-I to be acceptable? o Researchers will examine Teen CBT-I acceptability ratings. Teen CBT-I is hypothesized to improve insomnia symptoms in teens, and teens and parents are hypothesized to find Teen CBT-I to be acceptable. Teen participants will be randomized to one of the two conditions: Teen CBT-I treatment or waitlist control. They will also complete assessments at three timepoints: Baseline (before treatment); post-intervention (after treatment); and follow-up (2 months after treatment). For each assessment, teen participants will: * Fill out questionnaires about their sleep, mood, and other areas * Keep daily sleep logs for one week * Wear an actigraph, a wrist-watch like device that records activity levels to determine sleep-wake patterns, for one week. Parent participants will also be asked to complete questionnaires at each measurement point about their teen's sleep, mood, and other areas. The intervention conditions are: * Teen CBT-I includes 4-6 one-hour individual virtual sessions with a therapist. It includes standard CBT-I content with some small changes to match teen biology and lifestyles. The main parts of this treatment include healthy sleep habits, only using the bed for sleep, keeping a recommended sleep schedule, changing negative thoughts about sleep, and learning ways to relax the mind and body for sleep. * Waitlist-control, in which teens will not receive any treatment for 8 weeks. After the second assessment, they will receive free access to an app-based CBT-I treatment which they can complete on their own.
Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance.
The goal of this study is to learn about how children's sleep is related to their eating behaviors the next day, and to learn about factors that relate to eating behaviors and sleep health that are specific to preadolescent children living in rural communities.
Background: Mood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances. In this natural history study, researchers would like to learn more about the connection between exercise and mental health in people with and without mood disorders. Objective: To better understand relationships among physical activity, sleep, and mental health. Eligibility: People aged 12 to 60 years with a history of a mood disorder. Healthy spouses and relatives with no mood disorders are also needed. Design: Participants will be in the study up to 2 years. For up to 20 days in a row, at 4 times during the study, participants will: Complete an electronic diary on their smartphone. Participants will answer questions about their mood, health, sleep, and daily activities. Wear an activity monitor, like a wristwatch, that records how much they move. Wear a light sensor, as a necklace, to record the amount of light in their environment. Some participants will do additional tests. Twice during the study, for 3 days in a row, they will: Wear monitors to record their temperature, heart rate, and sleep. Provide saliva samples. Complete cognitive tasks on their smartphone. Participants will visit the NIH clinic 2 times. They will have a physical exam, with blood and urine tests. They will wear a heart monitor. They will ride a stationary bike for 30 minutes. They may have an imaging scan. Some participants will stay overnight. They will go to sleep wearing a cap to measure their brain activity.
Disordered sleep is a health issue with significant impacts on physical and psychological well-being that has increased in prevalence, but its impact on transgender adolescents has not been fully quantified. While there is found to be an impact of sex steroids on sleep, and sex-dependent differences in the impact of sleep duration and quality on insulin resistance (IR), there is limited available information regarding the impact of Gender Affirming Hormone Therapy (GAHT) for transgender individuals on sleep and IR. Our study aims to quantify the impacts of GAHT on sleep and IR in the pediatric transgender population as well as determine the degree of correlation of sleep to IR in this population.
Children with pulmonary hypertension (PH) engage in less physical activity than their peers. This is a concern since adult data support exercise as a non-pharmacologic treatment for PH. Despite adult data, therapeutic exercise has not been widely adopted in pediatric PH. Investigators have previously demonstrated that children with PH have less skeletal muscle mass in association with worse exercise performance. Interventions to increase physical activity and skeletal muscle mass may improve exercise performance and quality of life in children with PH. This study will use wearable activity monitoring devices to promote physical activity in a 16-week pilot intervention in children and teenager with PH.
The study will use a between-subjects design in a sample of individuals with BMI greater than or equal to 28 from the Los Angeles community (N=330). Participants will be randomly assigned to a weight stigma vs. control manipulation. Changes to the following health behaviors will be subsequently measured in their everyday lives: 3-day diet as captured by ecological momentary assessment (EMA) food diaries, objectively measured eating of obesogenic foods, objectively measured physical activity captured by 24-hour actigraphy, and sleep, captured objectively by overnight actigraphy and subjectively self-reported sleep measures. The investigators hypothesize that weight stigma causes decrements in health behaviors (e.g., sleep, eating, and physical activity) in everyday life.
This single blind study is to primarily evaluate wearable devices and Observer Reported Itch Assessment in children to assess reduction of itch and night-time scratch in response to Crisaborole treatment vs. vehicle treatment (active control comparator without crisaborole) in children with atopic dermatitis (AD). Participants, age 3 months to 11 years with symptomatic mild to moderate AD, along with their primary caregivers will be recruited. The goal of this study is to more fully evaluate the rapid onset of night-time itch and scratch relief, as well as improvements in sleep following treatment with Crisaborole in comparison to vehicle treatment in children with AD. the study will also assess the quality of life (QoL) and sleep within the associated caregivers.
Sleep is critical for health and quality of life; however, little is known about the prevalence or impact of non obstructive sleep apnea (non-OSA) sleep disorders in people with stroke. The proposed study aims to characterize the proportion of people with stroke that have non-OSA sleep disorders and their impact on recovery of activities of daily living, functional mobility, and participation along the continuum of recovery in people with stroke.
COHORT A: To study whether a digital health tool called Actigraph can be used to collect information on gait and physical activity in healthy children aged 3-17. The study will be conducted at the Pfizer Innovation Research Laboratory (PfIRe Lab) in Cambridge MA. In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. Children will wear 2 Actigraph devices, one as a watch and one as a belt. They will then go home and do usual daily activities while answering a brief daily activity diary for approximately 2 weeks. The conclusion of the study will be over the telephone and include questions on the comfort and wearability of the device. The analysis of gait and physical activity as well as adherence and wearability will be looked across three different age groups 3-5, 6-11, and 12-17. COHORT B: Cohort B of the study aims to evaluate the feasibility of the Panoramic Bracelet and associated algorithms such as SleepPy and GaitPy compared to the GENEActiv device and to evaluate the comfort and wearability of the Panoramic Bracelet. The results of this study will enable the use of novel devices in future clinical trials measuring scratch and sleep. . In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. They will then go home and do usual daily activities while wearing both devices in the same wrist at different times stipulated in the protocol, answering a brief daily activity and sleep diary for approximately 2 weeks. Cohort B includes questions on the comfort and wearability of the Panoramic device on Day 7 approximately. The conclusion of the study will be over the telephone.The analysis will be looked across three different age groups 3-5, 6-11, and 12-17