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Sleep Disorder clinical trials

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NCT ID: NCT04636112 Completed - Clinical trials for Acute Myocardial Infarction

Sleep Habits and AMI and Gensini Score

Start date: April 1, 2019
Phase:
Study type: Observational

This study was to examine the effects of sleep habits on acute myocardial infarction (AMI) risk and severity of coronary artery disease (CAD) in Chinese population from two centers. A total of 873 patients were recruited from the inpatient cardiology department of the Affiliated Jiangning Hospital and the First Affiliated Hospital of Nanjing Medical University. Investigators used a 17-item sleep factors questionnaire (SFQ) to evaluate sleep habits comprehensively by face-to-face interview.

NCT ID: NCT04598685 Completed - Obesity Clinical Trials

Early Vascular Ageing in the YOUth

EVA4YOU
Start date: February 1, 2021
Phase:
Study type: Observational

This is a single-center observational study on adolescents to determine predictors of the early steps of the formation of atherosclerosis and to quantify their influence on Intima-Media-Thickness of the carotid artery and the aorta and on the Pulse-Wave Velocity. A long-term follow-up by means of record linkage is furthermore planned to evaluate the effect of early atherosclerosis and the cardiovascular risk profile on future morbidity with a special focus cardio- and cerebrovascular events.

NCT ID: NCT04598425 Completed - Insomnia Clinical Trials

Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Mental Illness

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Insomnia is common in patients with co-morbid mental illness and sleeping difficulties is a frequent complaint in most psychological disorders. Mental illness may cause sleep problems, however, sleep problems like insomnia, may also cause or exacerbate mental illness. Insomnia may aggravate symptoms of depression, anxiety and fatigue, and reduce daily functioning in patients with co-morbid insomnia and mental illness. This project aims to evaluate a course offered to patients with insomnia and mental illness at Diakonhjemmet Hospital. The course is based on cognitive behavioral therapy, a documented treatment for insomnia.

NCT ID: NCT04584021 Completed - Quality of Life Clinical Trials

Use of Wearable Devices to Assess the Impact of Stress in Workers' Life Quality

SQoF-WEAR
Start date: July 1, 2019
Phase:
Study type: Observational

Introduction: Work stress has become more and more important in the last years as it affects both health and productivity of workers. In the last years, different wearables devices have started to be used to monitor stress at work to understand their consequences on daily life activity and sleep quality. Objective: to establish whether wearable wristbands are devices capable of determining the work stress level of workers from a research center in Galicia, for which different variables related to the work stress level and quality of life of these workers will be evaluated. Methods and analysis: The only inclusion criterion is to be a worker from a research center from Galicia. As for exclusion criteria, will not be allowed to participate those workers who are close to retirement ( <5 years), have health issues that hinder participation in the study, or present skin hypersensitivity or allergic reactions due to the materials the wristbands are made. This is a pilot study to determine the viability, sample size, cost, and duration of the study. 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. As for the statistical analysis, different tests will be performed to analyse the distribution, correlation, and association of the different features, as well as the significant differences between them at different points of the study (detailed below).

NCT ID: NCT04568408 Completed - Sleep Disorder Clinical Trials

Validation of the Quality of Sleep Data for Xiaomi Domestic Wristbands

Start date: August 4, 2020
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT04560595 Completed - Anxiety Clinical Trials

Remote Guided Caffeine Reduction

Start date: September 10, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04533815 Completed - Alzheimer Disease Clinical Trials

Enhancing Sleep Quality for Nursing Home Residents With Dementia

40Winks
Start date: May 5, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04480658 Completed - Sleep Disorder Clinical Trials

Effectiveness of Bryophyllum in Nocturia-Therapy

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04469972 Completed - Sleep Disorder Clinical Trials

Effect of Breathing Exercise on Certain Physiological Parameters, Sleep Quality and Vitality in Elderly

Start date: January 21, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04451668 Completed - Sleep Disturbance Clinical Trials

An Open Label Study of FT218 in Subjects With Narcolepsy

RESTORE
Start date: June 12, 2020
Phase: Phase 3
Study type: Interventional

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