View clinical trials related to Sleep.
Filter by:Musculoskeletal pain has become in a major problem related to its prevalence, treatment cost, absenteeism, quality of life impairment, disability and drugs consumption. The difficulty in musculoskeletal pain control ends in the abuse of drugs by these patients, including opioids. This drugs consumption has become a health problem in the United States and around the world related to their increasing abuse mainly between 2002 and 2011 and has had an impact in the numbers of deaths caused by opioids prescription (reaching 16,651 deaths in United States in 2010). Pain is clearly associated with sleep disturbances (50-80% of these patients suffer from a sleep problem), and in turn poor sleep quality leads to increased pain sensitivity. There is evidence showing that improving sleep disturbance co-occurring pain would improve, and some may reduce the use of opioids in specific patients on long-term opioid therapy. In spite of this reciprocal relationship between sleep and pain only few programs take into account the management of sleep disorders as a non-pharmacological measure for pain control. The hypothesis is: "to address sleep and circadian disorders (SCD) using a Sleep and Circadian Intervention Program (SCIP) in patients treated with rehabilitation by chronic musculoskeletal pain (CMP) optimizes the rehabilitation outcomes and reduces opioids consumption". Main goal: The aim of this PILOT study is to evaluate the feasibility of the protocol of the present study that aims to assess the improvement in rehabilitation outcomes and decrease in opioid consumption, through the management of sleep disorders. Methodology Using a randomised (1:1) controlled feasibility study, 50 men and women will be included to evaluate methodology and identify the potential outcome of the main project. Subjects older than 18 years included in a rehabilitation program by musculoskeletal lumbar pain lasting more than three months will be recruited. Basal Visit (BV): After the signature of informed consent, a medical history, physical exam, evaluation of the pain perception (EQ5D5L), quality of life evaluation (SF36 and FOSQ), mood and anxiety (HADS y PASS20), circadian rhythm study and drugs consumption will be evaluated in both groups. Patients will be randomized to control group (usual rehabilitation program) or intervention group (usual rehabilitation program + sleep circadian intervention program-SCIP). The patient in the SCIP program will received the next intervention: 1) Educational and circadian rhythm intervention: general sleep hygiene recommendation and promotion of daily physical activity. 2) Sleep studies for sleep quality and sleep disorders diagnosis: full polysomnography 3) Sleep questionnaires for another sleep disorders. Based on the results of the studies, patients will be treated according to current guidelines for the management of sleep disorders. 6 month after the SCIP starts patients will be evaluated in the End of Study Visit (EOS) as in the BV and also in their functional improvement and health resources consumption.
The purpose of this study is to examine, in healthy controls, whether LED lighting that has a color spectrum similar to that of sunlight is able to differentially impact mood, circadian rhythms, sleep, and behavior, as compared to standard fluorescent lighting.
The aim of this study is to improve sleep behavior in secondary school students, through the use of an educational program specifically designed for this purpose. Data will be collected on students' time use, sleep habits, daytime functioning and mood before and after the program to assess if the program is effective in improving students' sleep behavior and corresponding outcomes.
International data indicate that approximately 10% of the elderly will be affected by sarcopenia, a multifactorial syndrome that leads to the progressive and generalized loss of mass and muscular strength, leading to a decrease in quality of life, increased physical dependence, fragility, morbidity And mortality. Parallel to aging, it is well described in the literature that older people present a phase advance, which promotes alteration in the sleep-wake rhythm, as well as reduction of sleep time and quality. In this sense, two questions need to be answered: Do sarcosis elderly present major changes in sleep-wake rhythm and in sleep parameters when compared to non-sarcopenic elderly? The improvement of sarcopenia through resistance training is also related to the improvement of the sleep-wake rhythm of the sleep parameters. In order to answer these questions, the objective of the project is to evaluate whether sarcopenic individuals present changes in the sleep-wake rhythm and sleep quality at higher levels when compared to non-sarcopenic individuals and whether the benefits of resistance training for sarcopenic individuals are related to Regulation of sleep-wake rhythm and sleep patterns.
--> This is a substudy of the main ESTxENDS trial (NCT03589989). Sleep quality outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989. Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. The majority of attempts to quit tobacco smoking do not end in success due to unpleasant withdrawal symptoms. One of such symptoms is disturbed sleep. Sleep disturbances are a problem for smokers who are trying to quit. Sleep disturbances results from difficulty falling asleep or frequent arousals after sleep onset, and have negative daytime consequences such as sleepiness and dysphoric mood. Studies indicate that awakenings during night affect the cardiovascular system by providing repetitive bursts of sympathetic nervous system activation, likely contributing to elevated levels of cardiovascular and cerebrovascular morbidity. ENDS with nicotine containing e-liquids may be effective in assisting with tobacco smoking cessation by reducing withdrawal-induced sleep disturbances. This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events and the effect of ENDS on health-related outcomes and exposure to inhaled chemicals. For the main ESTxENDS trial (NCT03589989), cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-month period. Sleep quality will be assessed using the Pittsburgh sleep quality index- questionnaire at baseline and at 6, 12 and 24 months' follow-up.
The purpose of the research is to determine if protein and omega-3 fatty acid supplementation improve sleep, improve body composition, and improve markers of metabolic health in postmenopausal women.
This pilot study will test acceptability and feasibility of a sleep extension intervention in community dwelling, short sleeping, racially/ethnically diverse middle aged adults with Metabolic Syndrome (METs). Baseline sleep habits will be assessed and used to guide individualized strategies to extend sleep. A 1-group pre-test, post-test study design will test the efficacy of this 18 week study (2 weeks of baseline data collection, 1 week of study intervention planning, 12 weeks of sleep intervention planning, 12 weeks of sleep intervention delivery, final follow up 3 weeks after last day of the 12 week intervention) on sleep duration, MetS factors (waist circumference, blood pressure, fasting glucose, trigycerides, HDL-c), MetS risk behaviors (poor affective well-being, fatigue) and self regulation. Socio-ecological barriers and facilitators to the intervention will be identified using a quantitative and qualitative approach.
Sleep is an important contributing factor to people's health. However, over one third of the general population has sleep complaints, causing both health related problems, and economic impact. Many do not think their problem sleep is serious enough to consult a physician (primary care or sleep specialist). For a selection of this population, self-tracking devices can be a solution, but these trackers are often activity based and therefore lacking in their capacity to give insight into underlying causes of poor quality sleep and daytime fatigue. A new options for these confused sleeper is an online questionnaire, developed by Philips and Cooperative Research Center (CRC) for Alertness, Safety and Productivity Imagine a troubled sleeper awake at 3 am, they search "Why can't I sleep?" and find the survey. From there the user takes the sleep survey, which has the ability to assess their most likely sleep problem or problems from a list of seven sleep problem categories based upon their responses. At the end of the survey, participants will get information about which problem category they will fall into, and the level of certainty around that. The purpose of the study is to determine the accuracy of the questionnaire in identifying the correct sleep problem when compared with the assessment of a sleep physician in a clinical sleep center. We hope to enroll 200 participants which was based upon an Initial power analyses were completed using pilot data, assuming accuracy rates of 70, 80, and 90% and a total sample size of 200. The intervals would be about ± 4.5% (for 90%) to ± 7% (for 70%). Participants will complete the survey, be blinded to the results, and then have a consultation with a sleep physician who will make an independent assessment.
The project is aimed at identifying how the adrenergic antagonist 'carvedilol' modulates the effects of sleep deprivation in healthy volunteers. The study is a double-blind, randomized, placebo-controlled, cross-over study. Investigators will include 20 healthy volunteers who will undergo three functional magnetic resonance (fMRI) imaging sessions, one at baseline, and two after sleep deprivation (one night without sleep). The two sleep-deprivation scans are performed in a randomized order where subjects receive placebo or carvedilol, in a within-subject, cross-over study design. The following domains will be described: 1) fMRI imaging of cerebrospinal fluid (CSF) pulsations (glymphatic flow) in the human brain, performed by a combination of fMRI protocols that includes structural (T1, T2, diffusion weighted) and functional (multiband/fast imaging, spectroscopy) imaging. 2) fMRI imaging during wakefulness and sleep are determined by simultaneous electroencephalographic (EEG) recordings. 3) The effects of sleep deprivation on the fMRI derived glymphatic flow signal. 4) The effects of the adrenergic antagonist carvedilol on fMRI measurements and sleep intensity. 5) Quantification of cognitive performance before and after a nap in the MRI. Cognitive testing includes: assessments of visual attention, reaction time, paired-associative memory, working memory, emotional recognition and subjective ratings of sleepiness and mood.
Medical condition or disease under investigation : Quantitative and qualitative aspects of sleep, quality of life, functional ability and well-being in older adults (>55years) Purpose of clinical trial : To study the prospective effects of a healthy lifestyle program on quantitative and qualitative aspects of sleep, quality of life, functional ability and well-being in older adults. Primary objective : Measure the effects of the intervention on quantitative and qualitative aspects of sleep Secondary objective (s) : Measure the effects of the intervention on physical activity, quality of life, functional ability and well-being Social identity and leadership, social support and motivation Trial Design : Intervention study : controlled before-and-after study Sample Size : total sample size : 1.000 participants Summary of eligibility criteria : Older adults aged above 55years Included in intervention group : adults who are participating in the healthy lifestyle promotion program 'Lekker Actief', organized by OKRA Included in control group : waitlist controls or controls (adults, members of OKRA, not participating in the health promotion program 'Lekker Actief') Maximum duration of treatment of a subject : - Start of Health promotion program 'Lekker Actief' : September 2018 - Measurements with accelerometers will start prior to the health promotion program 'Lekker Actief' : July 2018 - End of Health promotion program 'Lekker Actief' : December 2019 - Duration of Health promotion program 'Lekker Actief': 12 weeks - Maximal duration : July 2018-December 2019