Active clinical trials for "Chronobiology Disorders"

Introduction 16.8% of the Danish adult population are obese (Body Mass Index> 30 kg / m2). Obesity increases the risk of lifestyle diseases such as type-2 diabetes and non-alcoholic fatty liver. People with mental illness have an increased risk of developing obesity. Both obesity and certain mental disorders (bipolar disorder and schizophrenia) are associated with circadian rhythm disorders. Clinically, this may manifest as reduced sleep quality, depressive symptoms and increased fatigue, but also deregulation of a wide range of bodily processes subject to the circadian rhythm. In circadian rhythm disorders, the pattern of how mRNA of specific 'clock genes' is expressed in the cell may be affected. These clock genes are associated with obesity, bipolar disorder and schizophrenia. Despite the clear indications of an interplay between mental illness, obesity and circadian rhythm disorders, the relationship between these illnesses are largely unexplored. Aim The aim of this study is to investigate circadian disturbances in people with and without obesity, as well as people with obesity and a comorbid diagnosis of either schizophrenia or bipolar disorder. Methods The study population will consist of: People with obesity and schizophrenia (N=22) People with obesity and bipolar disorder (N=22) People with obesity without psychiatric disease (N=22) People with BMI 18.5 - 25kg/m2 and no psychiatric disease (N=20) Study Procedure Participants will visit the clinic 2 times. At each visit participants fill in questionnaires and perform physical tests. Between visit 1 and 2, participants will over a 2-day period (at-home), collect biological samples (Four hair- and six saliva samples per day). In addition, participants will wear accelerometers and continuous glucose monitors (CGMs) for a total of 8 days, including the 2-day sampling period. Sampled hair follicles are analyzed for relative expression of clock gene mRNA. Saliva is analyzed for cortisol- and melatonin content. The four participants groups are analyzed and compared on daytime variation in mRNA expression, cortisol- and melatonin concentration, and body temperature. Perspectives A comparison of patient groups presenting with mental disease, obesity and circadian disturbances may provide new insight into the association between these diseases.

This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.

The precise role of the intrinsic circadian regulatory mechanism behind the pathogenesis of enuresis is not fully understood, but in theory, circadian rhythm irregularity may be the primary pathogenic mechanism not only for urinary outflow mechanisms but also for nocturnal bladder function. The proximity between SCN centers that control AVP release, sleep/arousal, voiding, and baroreregulation may provide the basis for circadian rhythm disturbance in one or more of these biological functions. Ganglion cells containing melanopsin pigment in the retina transmit the information they receive from the outside world about the light-dark state to the SCN via the retinohypothalamic pathway. Peripapillary retinal nerve fiber layer (RNFL) thickness, optic nerve head and macula are examined most frequently for the diagnosis of glaucoma and the detection of progression with optical coherence tomography (OCT). If differences in ganglion cell thickness can be detected using OCT in these children, a new avenue in Enuresis Nocturna may be opened.

Circadian rest-Activity Rhythm disorders (CARDs) are common in patients with cancer, particularly in advanced disease. CARDs are associated with increased symptoms, poorer quality of life, poorer response to anticancer treatments and shorter survival. The goal of this observational study is to see how common CARDs are in patients with advanced cancer and to characterise their rest and activity patterns in more detail. A recent study has outlined a standard way to assess and diagnose a CARD. This study aims to assess patients with advanced cancer for a CARD using a novel screening tool against this newly formed diagnostic criteria. Potentially modifiable risk factors will be considered along with associations between CARDs and symptoms, sleep preferences, sleep quality, daytime sleepiness, quality of life measures and predictors of survival.

Current methods for assessing circadian timing require sampling over hours (or even up to a day) while the patient is in controlled conditions. The investigators aim to develop a method that can estimate individual circadian time with a single blood sample taken at any time of the day or night. To do this, the investigators will use two state of the art methods, a plasma proteomics-based method to identify a panel of rhythmic proteins (extending our preliminary data) and a whole blood-derived monocyte-based method using a panel of 15 transcripts (to validate and extend a recent study). We will test both methods in a series of patients with circadian rhythm sleep disorders. We will validate separately the proteomics-based biomarker and the monocyte-based transcript biomarker, and also explore whether combining them can improve the accuracy of our timing estimates. In all cases, circadian phase estimates from the biomarker panels will be compared with those derived from plasma or saliva melatonin (the current "gold-standard" circadian phase marker).

The goal of this clinical study is to assess the effects of different photobiomodulation (PBM) conditions in men and women between 25 and 65 years old with daytime sleepiness/drowsiness and /or mild mood complaints but be otherwise healthy. The main question it aims to answer are: Does PBM significantly affect health and well-being? Are PBM effects wavelength dependent? Are PBM effects pulse dependent? Are the eyes needed to assert an PBM effect or is exposure only to the skin sufficient? What are the cellular, metabolic pathways underlying the systemic effects of PBM. Participants will have to: Exposed themselves 5 times per week during 2 weeks to the PBM stimuli between 9:30 and 12:30. A week before the baseline measurement, participants will have to start wearing a Fitbit Versa 3, and will have to continuously wear until the end of the study. In the afternoon of the baseline day as well as in the afternoons after 5 and 10 PBM sessions (week 1 and week 2, respectively), participants will have to go to the lab for blood withdraw. In the evening of the baseline day as well as in the evenings after 5 and 10 PBM sessions (week 1 and week 2, respectively), participants will have to collect saliva samples as well as to complete questionnaires. It will be a double-blind placebo-controlled field study with a between subject comparison.

Shift work is associated with disturbed life rhythms resulting from chronic exposure to circadian misalignment and sleep restriction, with long-term participation in most shift schedules causing serious health problems. Epidemiological data show that shift workers are at increased risk of sleepiness, fatigue and insomnia, cardiovascular disease, breast cancer and shift-work disorder. Prevalence estimates of shift-work disorder vary between 5% and 26,5%. Given these widespread and serious health and functional consequences of shift work, there is a necessity for treatments that improve shift workers' health and work performance. Most non-pharmacological recommendations mention improved scheduling, bright-light exposure, napping, psychoeducation fostering sleep hygiene, and cognitive-behavioral interventions. The effects of shift work on the health, fatigue and sleepiness of drivers have been robustly investigated in observational studies, as well as the effects of single measures such as scheduling or resting times. But studies on the effectiveness of countermeasures against the adverse impact of shift work are sparse, especially for high-risk populations such as professional drivers and controlled intervention studies are lacking. Several other investigators expounded the need for a multi-level approach to managing occupational sleep-related fatigue and workplace interventions to promote sleep and health of shift workers. Highlighting the high public-health burden associated with lack of recuperative sleep, the authors pointed out the pressing need to develop policies and implement programs aimed at improving workers' sleep health. With SHIFTPLAN, the investigators aim to fill this gap in comprehensive approaches. To their knowledge, this is the first randomised controlled trial to systematically gauge the effect of a multimodal program that includes ergonomic shift scheduling and an educational program on well-defined health, sleep and performance outcomes in professional drivers.

The main purpose of this study was to demonstrate that LML134 can increase wakefulness compared to placebo in patients with shift work disorder (SWD) measured by objective and subjective endpoints of wakefulness, i.e. the sleep latency in the multiple sleep latency test (MSLT) and the Karolinska Sleepiness Scale (KSS), respectively. Safety and PK of LML134 were also evaluated. In addition, novel methodologies to measure wakefulness and sleep were also to be tested and compared to gold standard methods like the MSLT and polysomnography (PSG) (at sites where staff have appropriate equipment and training). The aim of such comparisons was to evaluate the usefulness of the new technologies in clinical studies and provide preliminary validation data. This was a randomized, subject and investigator-blinded, placebo controlled, crossover, multi-center Proof of Concept (PoC) study with in-house simulated laboratory night shifts in patients with SWD. This non-confirmatory study included two treatment arms: LML134 and placebo. After a screening period, the treatment phase of the study consisted of two overnight stays in a sleep lab in each of two treatment periods, with a minimum one week wash-out in between.

An observational clinical study on the changes of intestinal flora between people with circadian rhythm disorders and healthy controls was conducted to explore the relationship between circadian rhythm disorders and human intestinal microorganisms. To reveal the effects of circadian rhythm disorder on human intestinal microorganisms and metabolism on other potential diseases. In this study, 40 people with circadian disorders and 40 healthy controls were recruited. During the study, blood, urine and fecal samples of the subjects were obtained once, and the obtained biological samples were tested and analyzed by serum, urine metabolomics and fecal metagenomics. Subjects were also evaluated on the following scales : Circadian Type Inventory（CTI ）. The Epworth Sleeping Scale ( ESS ), Fatigue Scale-14 ( FS-14 ), Maslach Burnout Inventory-General Survey ( MBI-GS ), Athens Insomnia Scale ( AIS ), Insomnia Severity Index ( ISI ), Pittsburgh sleep quality index ( PSQI ), Bristol Stool Scale, Gastrointestinal Symptom Rating Scale ( GSRS ), Connor-Davidson resi.

The primary purpose of this pilot study is to test a novel head worn light device (Re-Timer®) as an intervention to improve glucose metabolism in people with prediabetes. The hypothesis is that morning light treatment will improve glucose metabolism. This is a pilot study and the data from this project will be used to develop a larger clinical trial.