View clinical trials related to Sleep Wake Disorders.
Filter by:Introduction: Polysomnography (PSG) is currently the accepted Gold Standard for sleep studies as it measures multiple variables that lead to a clear diagnosis of any sleep disorder. However, it has some clear drawbacks as it can only be performed by qualified technicians, has a high cost and complexity and is very invasive. In the last years, Actigraphy has been used along with PSG for sleep studies. In this study, the investigators intend to assess the capability of the new Xiaomi Mi Band 5 to be used as a sleep self-assessment tool for patients. Objective: Determine whether sleep stages recorded by the new Xiaomi Mi Band 5 can effectively replace PSG sleep stages classification in patients that undergo a sleep study. Methods and analysis: the study will be carried out with patients in a hospital from A Coruña (Galicia, Spain) that are > 18 years old. Patients who are performed a polysomnography test will be given the wearables so the investigators can record sleep stages with both techniques in order to compare both recordings afterwards. This is an observational, analytic and longitudinal study. In other words, in this study different variables from the population of interest will be observed and recorded without any direct intervention, so as to establish causality associations between these variables. It is considered as longitudinal since a six-months tracking of the variables will be performed, continually (and sometimes occasionally) recording and monitoring sleep quality (wearable wristbands). The data obtained from PSG and Xiaomi Mi Band 5 will be preprocessed and explored before extracting the features of interest for the study. Then, Paired sample T-Test will be performed to compare the means among the different variables, Bland-Altman plots will be used to assess the concordance between both techniques and, finally, Epoch by Epoch analysis will be performed to compare the classification of the sleep stages carried out by both PSG and Xiaomi.
The purpose of this online research study is to determine whether or not a gradual caffeine reduction program developed at Johns Hopkins can help people reduce their caffeine use. The investigators will provide materials to help guide caffeine reduction and ask questions to track caffeine use over several weeks. The investigators will also assess how reducing caffeine may benefit common caffeine-related problems such as anxiety, sleep disturbances, and gastrointestinal distress. The study will also determine whether or not people like participating in this caffeine reduction program in an online format.
This was a pilot study (R61) to prepare for a full clinical trial (R33) aiming to improve clinical outcomes for an important, growing, and vulnerable population-nursing home (NH) residents with Alzheimer's disease or related dementias (ADRDs). The goal was to pilot and refine the research methods and intervention that would be subsequently evaluated in a full implementation trial (hybrid type III). The goal of the evidence-based intervention (LOCK) that was refined in this pilot study and will be evaluated in the subsequent full clinical trial is to improve the sleep of NH residents with ADRD.
COVID-19 is an infectious disease caused by the last coronavirus discovered, called SARS-CoV-2. Symptoms encountered in COVID-19 are: cough, breathing difficulties (dyspnea, chest pain, etc.), pyrexia, anosmia (loss of smell) and/or dysgeusia (loss of taste), but also ENT symptoms (rhinitis type, odynophagia), headaches, asthenia, muscle pain, confusion and diarrhea. Infection with SARS-CoV-2 can also be asymptomatic. COVID-19 can be passed from person to person by respiratory droplets expelled when a person speaks, coughs or sneezes. The currently estimated incubation period ranges from 1 to 14 days, and most often this is around 5 days. According to a literature review, there is strong evidence that COVID-19 has an impact on mental health (anxiety being the most common symptom) whether in the general population, healthcare workers or vulnerable populations. The objective of this project is to assess mental health and sleep disorders within two populations: elderly patients and nursing staff.
Night-time micturition, called nocturia, is a very common problem that unfavourably influences sleep- and life-qualities. The International Continence Society (ICS) defines nocturia as micturition once or several times during the night. Nocturia is one of the cardinal symptoms of overactive bladder (OAB). Persons with nocturia have the intention to continue sleep after going to the toilet which does not succeed to the same extent, depending on age. The natural occurrence of the plant, Bryophyllum pinnatum (BP) which is used in this observational study origins from Madagascar as well as in tropical Africa, South America and Asia. In the folk medicine of these countries BP is widely used. BP has a calming, spasmolytic, anti-inflammatory, pain-relieving, diuretic and cytotoxic effects. According to previous preclinical and clinical studies the inhibiting effect of BP on overactive bladder was proven. The pharmacological effect of this plant on uterine smooth muscle cells, on spontaneous and oxytocin-stimulated contractions, and on detrusor muscle cells in an in-vitro model of the pig's bladder was shown. Smooth muscle relaxation is not only required for preventing premature labour but also for symptom's relief of overactive bladder (OAB). The flavonoid, aglycons and bufadienolides, are components of the pressed juice of the BP leaves that have comparable effects to the standard drug oxybutynin on vesical smooth muscle cells. Since many year BP is used in obstetrics not only as tocolytics but also as a sedative and sleeping pill. There are known only few adverse events, such as skin irritation by intravenous application. The interest in phytotherapeutical drugs for treatment the chronic diseases is very high and Bryophyllum is also frequently used in Switzerland for hyperactive conditions. In Switzerland, following the vote on complementary medicine on 17.05.2009, alternative treatments will be covered by basic health insurance. Definitive inclusion in the catalogue of benefits will be granted if effectiveness, safety and cost-effectiveness can be demonstrated. The potential and side-effect profile of BP, as well as the social interest in research into alternative methods is the background to the implementation of this observational study.
Objective: To determine the effect of breathing exercises on certain physiological parameters, sleep quality and vitality in the elderly. Method: In this randomized controlled, experimental study, pre and post tests were applied to 26 elderly participants in the intervention group and to 25 elderly patients in the control group. The intervention group underwent breathing exercises for 30 minutes at the same time of the day, three days a week for three months (pursed-lip breathing exercise, deep breathing exercise, coughing exercise), while no such exercise was carried out by the control group. Pittsburg Sleep Quality Index, the Subjective Vitality Scale, spirometer, sphygmomanometer and pulse oximetry device measurements were used for the collection of data. The data was evaluated with an independent sample t-test, a paired-sample t-test and a two-way repeated measures ANOVA.
An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy
There is a long-standing assumption that physical activity is an effective, non-pharmacological approach to improving sleep quality and quantity. However, objective and reliable data on this relationship are scarce for children with developmental disabilities. Parent burnout in this population is high and there are many barriers to engagement with such interventions. This study aims to understand the feasibility of providing an exercise intervention for this population, and gathering parental views on the impact of such an intervention. Depending on the outcome of this feasibilty study, larger scale interventions may be planned to further examine the impact of such an intervention.
Objectives: To determine the effectiveness of a warm foot bath on sleep quality and comfort level among elderly individuals with sleep problems. Design and methods: This study was a randomized controlled trial. A total of 217 elderly individual who stayed in two nursing homes. The sample consisted of 60 elderly individuals with sleep problem who were randomly assigned to either the warm foot bath group (n= 30) and control group (n=30).The study was completed with 60 elderly individuals. The primary outcome was an information questionnaire, the Pittsburgh Sleep Quality Index, the General Comfort Questionnaire and the Numerical Rating Scale.
The Obstructive Sleep Apnea is characterized by obstruction of the upper airway during sleep (for at least 10 sec), with repeated breathing pauses, accompanied by oxygen desaturation in the blood and by sleep interruption with repeated arousals. The investigators hypothesized that good sleep hygiene, the execution of respiratory rehabilitation exercises, with specific myofascial exercises on the muscles that are compromised in the Obstructive Sleep Apnea, can improve the patient's clinical outcome and quality of life. The objective of this study is to evaluate the effect of respiratory rehabilitation with myo-functional exercises in mild obstructive sleep.