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Chronobiology Disorders clinical trials

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NCT ID: NCT06370962 Not yet recruiting - Cystic Fibrosis Clinical Trials

Circadian Rhythm Disorders in Children With Cystic Fibrosis Under CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators

CHRONO-MUCO
Start date: May 2024
Phase:
Study type: Observational

Cystic fibrosis (CF) is a rare disease affecting one out of 4,500 newborns in France (INSERM 2021). Despite major advances in patient care over the past two decades, with significant improvements in life expectancy, cystic fibrosis remains a pathology that considerably impairs quality of life. Several studies have reported the possibility of respiratory and non-respiratory sleep disorders (SD) in patients with CF. Respiratory disorders are reported to affect 30% of children with CF (Barbosa 2020). Among non-respiratory SD, sleep onset and maintenance insomnia are well known in these patients, while chronotype abnormalities (circadian rhythm disorders) are understudied. Chronotype refers to a person's tendency to be more efficient in the morning or evening. The existence of chronotype abnormalities has been suggested in CF patients, but no precise data are available (Louis 2022). The involvement of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) protein dysfunction in the central nervous system (CNS) has been hypothesized as a contributory factor. In vivo, in a mouse model of CF, dysregulation of clock genes such as Clock, Cry2 and Per2 was found in the CNS (Barbato 2019). Among them, certain genes such as Rev-erbĪ± could regulate endobronchial inflammation and contribute to the severity of respiratory pathology. All in all, chronotype abnormalities could be at the origin of sleep debt, impaired cognitive functions or metabolic disturbances. In the era of highly effective modulator therapy (HEMT) for the treatment of CF, the impact of these new therapies on chronotype has been understudied. Assuming that chronotype abnormalities are a direct consequence of CFTR protein dysfunction in the retina and anterior hypothalamus, HEMT should improve sleep quality. However, between 20% and 30% of adult and pediatric patients express an increase in chronotype abnormalities following initiation of treatment. Paradoxically, the perceived gain in respiratory quality of life is counterbalanced by the occurrence of these disorders. Some patients would effectively reverse their treatment in order to limit the phenomenon. A single polysomnographic study evaluated the effect of HEMT Kaftrio-Kalydeco on sleep in adults with CF (Welsner 2022). After 3 months of treatment, patients had a significant reduction in respiratory events, with no change in total sleep time, sleep efficiency or sleep architecture. Chronotype was not mentioned. Currently, no studies on chronotype in children or adults with CF have been carried out. Our hypothesis is that CF patients treated with HEMT would develop an abnormal chronotype of late sleep onset. The aim of this study is to evaluate the chronotype of children with CF treated with HEMT. Chronotype abnormalities could have major consequences for quality of life, the immune system, cognitive functions and metabolism. Systematic detection of these disorders via anamnesis, followed by diagnosis by questionnaire, actimetrics and/or urinary melatonin dosage, would enable their early management, starting with the reversal of Kaftrio-Kalydeco intake between morning and evening.

NCT ID: NCT06346613 Recruiting - Critical Illness Clinical Trials

Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU

Start date: March 7, 2024
Phase:
Study type: Observational

Most ICU patients experience sleep and circadian disruption (SCD), which causes a profound negative impact on patients, such as prolonged mechanical ventilation, glucose intolerance, and the occurrence of delirium. In order to better promote the alignment of circadian rhythm in ICU patients, this project will explore the prevalence of SCD and a series of influencing factors contributing to SCD in ICU patients, to help construct targeted intervention programs in the future.

NCT ID: NCT06329479 Recruiting - Cancer Clinical Trials

A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Circadian rest-activity rhythm disorders are common in patients with cancer, particularly in advanced disease. A recent international e-Delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. Affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention.

NCT ID: NCT06288568 Not yet recruiting - Obesity Clinical Trials

Night Shift Work and Biomarkers of Obesity Risk in Hospital and Industry Workers

Shift2Health
Start date: April 1, 2024
Phase:
Study type: Observational

Shift work is a well-known risk factor for the development of overweight and obesity, which may lead to downstream effects such as increased risk of cardiometabolic diseases and cancer. However, the biological and behavioral mechanisms underlying the obesogenicity of night shift work are not well understood. Population-based mechanistic studies in real life shift workers are needed to address how night shift work impacts metabolic health. The investigators aim to characterize the behavioural, environmental, and biological mechanisms and pathways for the association of night shift work and obesity across Europe. The investigators will conduct a cross sectional study in 5 European countries (Austria, Denmark, Germany, Netherlands and Poland) and recruit 1000 rotating night shift workers and day workers (200/country) from the health sector and different industries. Night and day workers will be age-frequency (3 age groups), gender and (where possible) working tasks matched. Participants will complete online questionnaires and report their diet habits in a mobile app. Body composition, dietary behavior and sensory preferences will be tested. Biologic specimens (blood, urine, saliva, hair and feces) will be collected at the workplace on a day where participants are working on a day shift (or a day off). In a subsample (Austria and Netherlands) shift workers will provide biological samples (spot blood, urine and saliva) both on a day shift and on a night shift. Biomarkers including hormones, cellular immunity and inflammation, parameters linked to gut health and metabolism of fat and sugar, appetite, oxidative stress, metabolomics and microbiota will be measured. The investigators hypothesize that compared to day workers, night shift workers will experience disrupted levels of pre-obesity markers. Higher circadian disruption, sleep disruption and mistimed eating patterns workers will be associated with more disrupted biomarker profiles. Among rotating shift workers, night shift will be associated with acute disrupted melatonin production, metabolomic profiles and composition of oral microbiota compared to a day shift.

NCT ID: NCT06129942 Recruiting - Parkinson Disease Clinical Trials

Light Therapy in Parkinson's Disease

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease.

NCT ID: NCT06083831 Recruiting - Critical Illness Clinical Trials

The Effect of Sequential Feeding for Circadian Rhythm and Gut Flora Rhythm in Critically Ill Patients

Start date: October 7, 2023
Phase:
Study type: Observational

Circadian rhythms plays an important role for healthy. And critical illness contributes to the disruption of circadian rhythms. Not only right but also feeding can affect the circadian clock gene expression. In a investigators' previous study, some metabolic indicators (the albumin level, total cholesterol level and total bile acid level) and the increases in lymphocyte counts in the sequential feeding group were different from those in the continuous feeding group. Investigators think sequential feeding may adjust circadian clock gene expression for its effect on metabolism and immunity. Moreover, sequential feeding did alter the abundances of some gut microbes to some degree in the investigators' previous study. Investigators think sequential feeding may adjust gut flora rhythms.

NCT ID: NCT06023654 Recruiting - Cancer Clinical Trials

Identifying Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer

Start date: May 15, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05995132 Recruiting - Clinical trials for Circadian Dysregulation

Compromised Sleep and Circadian Health After Critical Illness: From Diagnosis to Prediction (CHRONOCRIT)

CHRONOCRIT
Start date: September 27, 2023
Phase:
Study type: Observational

The intensive care unit (ICU) is recognizably detrimental to sleep and circadian health, and critical survivors frequently report the presence of alterations in this regard after hospital discharge. However, an appropriate evaluation of sleep and circadian rhythms is often neglected given the high associated cost and/or the need of collaboration of the patients. In this project, the investigators propose alternatives to ultimately improve the management of sleep and circadian health after critical illness. The researchers will evaluate the role of microRNA (miRNAs) expression profile in identifying the compromised sleep and circadian health of critical patients during the ICU stay, in the short (3 months after hospital discharge), and in the long-term (12 months after hospital discharge). Also, models based on machine learning techniques will be developed to predict adverse outcomes in this regard after hospital discharge.

NCT ID: NCT05986604 Recruiting - Sleep Disorder Clinical Trials

NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment

Start date: January 4, 2024
Phase: N/A
Study type: Interventional

Mental illness is often chronic, severe, and difficult to treat. Though there has been significant progress towards establishing effective and efficient interventions for psychological health problems, many individuals do not gain lasting benefits from these treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings from the cognitive science literature to improve treatment outcomes. In this study, the investigators aim to conduct an open trial that includes individuals 50 years and older to assess if a novel version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.

NCT ID: NCT05956678 Enrolling by invitation - Clinical trials for Circadian Rhythm Disorders

Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 3: Sustainment

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Research on the sustainment of implemented evidence-based psychological treatments in routine practice settings, such as community mental health centers, is limited. The goal of this study is to test sustainment predictors, mechanisms, and outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in community mental health centers after implementation efforts have ended. CMHC providers have been trained to deliver a "Standard" or "Adapted" version of TranS-C. Researchers will compare these two groups to evaluate differences--and possible mechanisms--with respect to sustainment outcomes.