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Chronobiology Disorders clinical trials

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NCT ID: NCT05956678 Completed - 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.

NCT ID: NCT05805657 Active, not recruiting - Sleep Disorder Clinical Trials

Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 2: Train-the-Trainer

Start date: December 14, 2020
Phase: N/A
Study type: Interventional

The train-the-trainer (TTT) approach is a promising method of sustaining training efforts in community mental health centers (CMHCs). This study will test the implementation and effectiveness outcomes of a sleep treatment delivered by CMHC providers who are trained and supervised within CMHCs via TTT. The investigators will test two versions of the sleep treatment, a "Standard" version and an "Adapted" version that has been adapted using theory, data and stakeholder inputs to improve the fit for SMI patients treated in community mental health centers.

NCT ID: NCT05694481 Not yet recruiting - Clinical trials for Circadian Rhythm Disorders

An Observational Clinical Study on the Intestinal Flora in Circadian Rhythm Disorder and Healthy Controls

Start date: January 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05619133 Not yet recruiting - Sleep Deprivation Clinical Trials

PBM Effects on Health and Well-being in Humans

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

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: 1. Does PBM significantly affect health and well-being? 2. Are PBM effects wavelength dependent? 3. Are PBM effects pulse dependent? 4. Are the eyes needed to assert an PBM effect or is exposure only to the skin sufficient? 5. What are the cellular, metabolic pathways underlying the systemic effects of PBM. Participants will have to: 1. Exposed themselves 5 times per week during 2 weeks to the PBM stimuli between 9:30 and 12:30. 2. 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. 3. 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. 4. 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.

NCT ID: NCT05618405 Recruiting - Anesthesia Clinical Trials

Changes in Circadian Rhythm After Anaesthesia in Children

CLOCKSkids
Start date: March 16, 2022
Phase:
Study type: Observational

In this study the investigators will examine the effect of general anesthesia and surgery on sleep duration and sleep quality in children, using questionnaires and a sleep diary.

NCT ID: NCT05452096 Not yet recruiting - Quality of Life Clinical Trials

SHIFTPLAN: an RCT Investigating the Effect of a Shift Work Intervention on Fatigue, Sleep and Health.

SHIFTPLAN
Start date: October 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05413486 Recruiting - Obesity Clinical Trials

Sleep, Obesity and Mental Disease - Biological Markers for the Evaluation of Circadian Rhythmicity

SOMBER
Start date: April 4, 2022
Phase:
Study type: Observational

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: 1. People with obesity and schizophrenia (N=22) 2. People with obesity and bipolar disorder (N=22) 3. People with obesity without psychiatric disease (N=22) 4. 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.

NCT ID: NCT05309577 Recruiting - Alzheimer Disease Clinical Trials

Self-Care for Dementia Caregivers

Care2
Start date: March 7, 2023
Phase: N/A
Study type: Interventional

The Self-care for Dementia Caregivers Study is a behavioral health intervention that uses digital monitoring tools and motivational health coaching to help caregivers of persons with dementia engage in a regular routine of self-care. Participants wear an apple watch for the objective collection of sleep-wake rhythms. They receive personalized feedback on their sleep-wake rhythms via a new app. Health coaches call participants weekly, for 6 weeks to help participants meet their health/sleep goals and promote self-knowledge of regular routines. Participants will help the study team improve the design elements and content of the mobile app. The goal of this intervention is to reduce psychological distress and caregiver burden.

NCT ID: NCT05263232 Completed - Clinical trials for Diabetes Mellitus, Type 2

Metabolic Effects of Natural Office Light in Type 2 Diabetes

Start date: March 16, 2022
Phase: N/A
Study type: Interventional

This study will investigate the potential benefit of scheduled natural daylight exposure to improve glucose control in type 2 diabetes (T2D) patients and to unravel molecular mechanisms underlying the effects of natural daylight on circadian clocks and (glucose) metabolism in human skeletal muscle from T2D patients. Participants will stay at our research facilities and will be exposed to natural daylight or artificial light during the daytime over 4.5 days in a randomized cross-over design. For both conditions, the evening and night will be spent under standardized dim and dark conditions.

NCT ID: NCT05228444 Recruiting - Clinical trials for Circadian Rhythm Disorders

Managing Sleep-wake Disruption Due to Hospitalisation: the Circadian Care Project

CircadianCare
Start date: October 28, 2020
Phase: N/A
Study type: Interventional

Sleep is regulated by the interaction of homeostatic and circadian processes. The homeostatic process determines sleep propensity in relation to sleep-wake history, the circadian one is responsible for the alternation of high/low sleep propensity in relation to dark/light cues, and is substantially independent of preceding sleep-wake behaviour. The circadian timing system encompasses a master clock in the brain and peripheral, ancillary time-keepers in virtually every organ of the body. In recent years, evidence has emerged that circadian disruption has serious medical consequences, including sleep loss, increased cardiovascular morbidity and increased risk of certain types of cancer. Evidence is also emerging that hospitalization per se weakens circadian rhythmicity, due to disease itself and to modified light, food and activity cues. The aim of our project is to test an inpatient management system (CircadianCare) that limits the circadian impact of hospitalisation by enhancing circadian rhythmicity through an assessment of the patient's specific circadian features/needs and an ad hoc, personalized light-dark, meal and activity schedule to cover the whole of the inpatient stay. This will be compared to standard inpatient management in terms of patients' perception, sleep-wake quality and timing during hospitalisation, inpatient utilization of sleep-inducing medication, length of hospitalisation, and prognosis (i.e. outcome of hospitalisation, subsequent hospitalisations and post-discharge sleep-wake disturbances). The CircadianCare system is expected to benefit prognosis, decrease costs, and change the way hospitals are organized and designed in future, with potential direct relevance to the plans for the new University Hospital of Padova.