View clinical trials related to Chronobiology Disorders.
Filter by:Mood and circadian rhythm disruptions are associated with binge eating (BE). BE is a discrete, episodic behavior characterized by 1) eating an objectively large amount of food and 2) experiencing a subjective sense of loss of control. BE episodes are often preceded by negative mood states, and a subtype of individuals with BE has high levels of negative moods. This group has more comorbid psychopathology and a poorer response to treatment. Thus, understanding the role of negative mood is a critical area for research on BE. Individuals with BE demonstrate disruptions in several circadian rhythms, including diurnal meal timing, hormone patterns (e.g., daily cortisol rhythms), and mood variations. The most potent synchronizer of circadian rhythms is light. Thus, exposure to light may explain other phenomena that fluctuate similarly, such as mood and the occurrence of BE. Mood is subject to the influence of light, and BE is also influenced by exposure to bright light. It is unknown whether regulating circadian rhythms via regular exposure to light improves BE through its effects on mood or via changes in other biological or behavioral rhythms. This knowledge can inform the development of treatments targeting biobehavioral mechanisms that maintain BE and indicate for whom this may be most effective. This project aims to test the roles of negative mood and circadian rhythms in the relationship between light exposure and BE and identify subtypes of individuals in whom this effect is strong. The investigators hypothesize that individuals exposed to less natural bright light will experience more frequent BE, more negative mood, and a blunted morning cortisol response. The investigators further hypothesize that manipulating exposure to artificial bright light will reduce the frequency of BE and negative mood and increase the morning cortisol response. Finally, the investigators hypothesize that the effects of this artificial bright light exposure on BE frequency will be mediated by changes in negative mood, which itself will be accounted for by changes in circadian rhythms as indicated by the morning cortisol response. Additionally, the investigators have two moderation hypotheses: that the effects of artificial bright light exposure on BE will be greater for those who fit the high negative mood type than those who do not and that the effects will be greater for individuals with a blunted morning cortisol response at baseline than for those without.
patients 6-25 years old upon diagnostic evaluation will be recruited . study population will comprise of two groups: newly diagnosed IBD patients/ Celiac disease and healthy controls. upon enrollment, subjects will fill out sleeping habits questioners, demographic data, medical history. blood samples will be drawn for CRP and clock gene expression in systemic WBC. intestinal biopsies will be snap frozen for clock gene extraction and amplification only for patients with IBD.
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 study aims to develop and test a user-friendly, accessible approach to sleep assessment which can function as an initial "triage" of targeted sleep conditions, such as insomnia, insufficient sleep syndrome, sleep apnea syndromes/snoring, and circadian sleep/wake disorders, within the clinical and community population. Specifically, this study will test the validity and reliability of a self-rated, digitized, and cost-effective diagnostic measure with sufficient sensitivity to accurately assess/diagnose common sleep conditions and/or risk for these conditions. Such an approach, would allow for faster assessment of common sleep conditions and disorders, and provide clinical knowledge to the individual, the physician, and if required insurance companies, as to those persons who need more immediate attention or treatment for their sleep condition.
Shift work deeply impacts on temporal organization leading to a circadian desynchronization, which translates into a worsening of the sleep quality and work ability during waking hours. Furthermore, also the fine motor control skills and the subjective mood profile could undergo modifications in relation to the acquired sleep debt. The misalignment between working time and physiological/behavioral functions could have negative influences on the levels of spontaneous daily activity, with possible alteration of the activity-rest rhythm of the worker, especially in clinics. In relation to the participants' chronotype, the aim of this project will be to evaluate the effect of irregular working hours (shift work) on (i) the sleep quality, (ii) the circadian rhythm of activity levels and, (iii) the motor control. These assessments will help to identify the shift type with less impact on the health status in a nurse cohort.
A multidisciplinary investigation examining the circadian mechanisms regulating cardiovascular (CV) risk in obesity. Specifically, in a valid circadian protocol, the investigators aim to study resting cardiovascular risk markers and the reactivity of circadian rhythms in these risk markers to standardized stressors in obesity. Furthermore, using an ingenious approach, the investigators propose to explore impairment in pre/post synaptic function in the cardiac left ventricle.
In the majority of intensive care units, nurses work 12 hour shifts that consist of days and nights. Shift work outside of 6am-6pm has been reported to cause fatigue, induce sleep disorders, and cause metabolic disturbances. This shift to a nocturnal 'day' rather than diurnal, can result in reduced work performance, processing errors, accidents at work, absenteeism, and reduced quality of life. More chronically, those working at night have been shown to experience higher risks of heart disease, cancer and shorter median durations of life span. Much of this elevated risk is thought to be due to altered exposure to light, the dominant environmental cue regulating our circadian rhythms. As diurnal organisms much of our biology is regulated by the solar day. Acutely, bright light exposure (i.e., sun) regulates the phase of the biological clock principally through the suppression of melatonin, which biologically mediates increased alertness and in essence, 'our daytime alertness'. During the night melatonin gradually increases and induces tiredness and ultimately sleep. This, in part, is biology behind the use of melatonin in those with sleep disturbances or to mitigate jet lag, with cross-continental or transoceanic flights. In this study, the investigators will randomize nurses in the hospital to receive either high intensity white light (3,000 lux) or standard ambient white fluorescent (~400 lx) light for 10 hours during their night shift. This high illuminance light, rich in blue spectrum, is what diurnal creatures, like humans, are exposed to during the day. The lights may subsequently be equipped with blue filters (442 nm) to heighten the exposure to the rich blue spectrum light. Exposure will commence at the beginning of the night shift (~7pm) and continue for 10 hours. The rationale for terminating exposure prior to shift end is to foster an onset of sleep biology. At the end of each shift, the nurses will complete the Stanford Sleepiness Scale and the Psychomotor Vigilance Task (PVT). Saliva samples will be collected for melatonin level analysis and the nurses will complete sleep diaries at home. The investigators hypothesize that exposure to high intensity lighting during night shifts will reduce fatigue and enhance alertness and computational capacity that correlates with reduced melatonin.
Cancer related fatigue (CRF) is a stressful and constant tiredness related to cancer and/or its treatment. CRF is the most intense during treatment and can severely interfere with activities of daily living, such as tasks that require physical strength or thinking clearly. Prevalence of CRF has been reported to be as high as 94% during chemotherapy and as high as 34% five years after completion of treatment (Rotonda et al. 2013; Minton & Stone 2008). There is currently no generally-accepted treatment for CRF. However, there is evidence to suggest that light therapy can help with CRF. Non-pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden, particularly among those in active treatment. Given the clinical impact of CRF, the goal of this project is to investigate a novel, low-cost and low-burden intervention for Breast Cancer patients using a particular kind of light treatment called systematic light exposure (sLE) to treat CRF. Two hundred forty-eight breast cancer (BC) patients undergoing adjuvant or neoadjuvant chemotherapy will be recruited from Memorial Sloan Kettering Cancer Center, and City of Hope. The light will be administered by light glasses daily throughout entire duration of chemotherapy. Outcomes will be assessed at eight timepoints during chemo, and a series of follow up assessments at 1 week, 1-month, 3-months and 6-months post-chemotherapy. This study will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively reduces CRF or prevents it from worsening during chemotherapy. Specific Aims: Aim 1: Determine if sLE prevents CRF from worsening in BC patients undergoing chemotherapy Aim 2: Determine whether sLE affects sleep, depression and circadian activity rhythms. Exploratory Aim 3: Investigate sLE normalizes circadian cortisol rhythms. Exploratory Aim 4: Examine whether the effects of sLE on fatigue are moderated/mediated by sleep quality, depression, and/or circadian rhythms.
A sample of 60 patients scheduled for HSCT in the treatment of MM will be recruited in the weeks to months prior to their hospitalization. Light therapy incorporating ambient Programmed Environmental Illumination (PEI) will be used in patient hospital rooms (during scheduled transplant) to control cancer-related fatigue (CRF). The FDA has certified that light therapy, like that used in this study, is a low-risk intervention. When admitted to the hospital for a stem cell transplant, there will be a light fixture in the hospital room which the researchers will be testing to see how it may affect cancer related fatigue, sleep quality, and other negative side effects often seen with the transplant and subsequent treatment. The light fixture will turn on and off by itself in the morning. There are two treatment arms used in the study, each of the arms uses different light intensities. The study treatment received, i.e. which of the two lights, will be chosen by chance, like flipping a coin. There is an equal chance of being given each study treatment. Participants will not be told which study treatment they are getting until after the study is completed. Each light will be turned on from 7 AM to 10AM every day during transplantation. While in the hospital, assessment of fatigue, sleep activity, depression, circadian rhythms, and quality of life will continue through the course of hospitalization (14-21 days of treatment, to determine immediate impact of sPI), then repeat at one month and three months post-discharge follow-ups (to determine lasting effects). Outcomes will be assessed through standardized scales (e.g., FACIT-Fatigue Scale) and objective measures (e.g., actigraphy, daysimeter for light monitoring, melatonin from urine collection, blood inflammatory markers, all explained below). This trial will: 1) be the first randomized clinical trial (RCT) to investigate the effects of sPI to prevent CRF and other biopsychosocial side effects of transplant; 2) focus on a distinct, relatively homogenous patient population (MM-HSCT patients) with high prevalence of CRF; and 3) explore possible circadian rhythm mediation via melatonin analysis and blood analysis. This investigation will have major public health relevance as it will determine if an inexpensive and low patient burden intervention (sPI) is able to control fatigue associated with medical illnesses and related problems.