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Parasomnias clinical trials

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NCT ID: NCT05551325 Recruiting - Critical Illness Clinical Trials

Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle

ReAlign-ICU
Start date: May 13, 2024
Phase: N/A
Study type: Interventional

More than 5 million patients are admitted to the intensive care unit every year in the United States; most of these patients experience profound sleep and circadian disruption. Promotion of circadian alignment (i.e., alignment of the body's clocks) would make it possible to strategically schedule behaviors such as sleep and eating at normal body clock times, which is predicted to improve sleep quality and metabolic function. This project will test the ability of a sleep chronobundle (i.e., sleep promotion and circadian treatment bundle) to normalize circadian alignment and subsequently test if this realignment also improves sleep and metabolism.

NCT ID: NCT05544201 Completed - Alzheimer Disease Clinical Trials

Transcranial Alternating Current Stimulation (TACS) for Sleep Disturbances in Neurocognitive Disorders Due to Alzheimer's Disease

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Background: Sleep disturbances are highly prevalent in ageing population and patients with age-related neurodegenerative diseases, which severely affect cognition and even lead to accumulated amyloid-β (Aβ). At present, non-pharmacological interventions for sleep disturbances in dementia patients are accepted as first line of treatment, of which the evidence from clinical trials is very limited. Encouraging results from recent studies on transcranial direct current stimulation (tDCS) showed moderate positive effects on sleep quality in preclinical Alzheimer's disease (AD). Compared to tDCS, high-definition transcranial alternating current stimulation (HD-tACS) enables the entrainment of neuronal activities with optimized focality through injecting small electric current with a specific frequency and has significant enhancement effects on slow wave activities. Objectives: The investigators aim to 1) investigate and compare the safety, efficacy and sustainability of 40 Hz HD-tACS and HD-tDCS over left dorsolateral prefrontal cortex (DLPFC) in mild neurocognitive disorder due to AD (NCD-AD) patients with sleep disturbances; 2) examine the relationship between the changes in sleep quality, cognitive function and saliva Aβ levels. Methods: Chinese right-handed mild NCD-AD patients with sleep disturbances (aged from 60 to 90 years) will be randomly assigned to a 4-week intervention of either HD-tACS, HD-tDCS, or sham HD-tCS, with 33 participants per arm. Before intervention, structural magnetic resonance imaging (MRI) data is used to construct individual realistic head model. Comprehensive assessments, including sleep quality, cognitive performance and saliva Aβ levels will be conducted at baseline, 4th week, 8th week, 12th week and 24th week. Program adherence and adverse effects will be monitored throughout intervention. Data analysis: The primary outcomes will be the changes in sleep quality and memory performance with modality-driven paradigms (HD-tACS, HD-tDCS, sham HD-tCS), and comparisons of group differences across different time points. Secondary outcomes will be the changes objective sleep pattern, global cognition, saliva Aβ levels and quality of life. Intention-to-treat analysis will be carried out. Changes of efficacy indicators from baseline to each follow up point will be tested with mixed effect model. Significance: This study aims to investigate the feasibility, safety and efficacy of HD-tACS and HD-tDCS over left DLPFC for sleep disturbances and cognitive dysfunction in mild NCD-AD patients. It wills also test the program adherence, tolerability and adverse effects of this innovative neurotechonology. Information will be helpful for in-depth understanding the relationship of "sleep disturbances-amyloid deposition" and guiding the further studies of sleep medicine and neurodegenerative diseases.

NCT ID: NCT05541692 Completed - Insomnia Clinical Trials

Efficacy of a Sleep Hygiene Toolkit for Patients in ARU

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Sleep Hygiene Study Abstract: INTRODUCTION Sleep is integral to the health of a person and can have multifaceted contributions to a person including their physical, cognitive, and psychosocial well-being. However, within a recent survey evaluating the sleep perception of patients within an acute rehabilitation unit (ARU), there was a high prevalence of reported sleep disturbances and poor sleep hygiene compared to at home (Davis et al., 2021). In addition, patients within an ARU generally have an extended length of stay-which could mean many nights of poor sleep hygiene. Given the importance of sleep in facilitating a person's health and recovery versus the challenges the hospital environment poses on patient's sleep hygiene, this study aims to examine the efficacy of a sleep hygiene toolkit provided to the patients admitted to ARU. The sleep hygiene toolkit includes multiple non-pharmaceutical resources addressing sensory stimulation and psychological and emotional needs. OBJECTIVE This study aims to evaluate the perception of sleep quality experienced by ARU patients utilizing the sleep hygiene toolkit. This study hypothesizes that with the use of a sleep hygiene toolkit, patients will report a positive impact on their sleep quality during their hospital stay. METHODOLOGY This is a within-subjects study design. All eligible participants will be given the sleep hygiene intervention administered for a period of five days. The sleep hygiene toolkit includes multiple resources including assistive devices (ie. eye masks and ear plugs), sensory-based tools (ie. aromatherapy, music, meditation, and breathing techniques), cognitive behavioral therapy (CBT) activities (ie. addressing anxiety and worry), and education and training on sleep hygiene. The visual analog scales on the Richards-Campbell Sleep Questionnaire will be used to assess patient's overall sleep perception pre- and post-intervention. CONCLUSION Given this prevalent area of need for patients admitted to ARU, occupational therapists (OT) can offer an additional way to address it. According to the Occupational Therapy Practice Framework (2020), OTs are well-equipped to provide comprehensive treatment to promote a person's sleep preparation and sleep participation. The results will determine the efficacy of a sleep hygiene toolkit for ARU patients in addressing their sleep needs-an important component in a patient's health and recovery during their hospital stay. SIGNIFICANCE OF TOPIC This study aims to highlight the barriers to successful participation in the occupation of sleep and rest for patients admitted to an acute rehabilitation unit (ARU). The creation of this sleep hygiene toolkit is to address a person's sleep preparation and sleep participation. Although sleep quality and its impact are a topic well studied, there is limited study on occupational therapy led interventions aimed to benefit the patient's sleep quality in an ARU setting.

NCT ID: NCT05536817 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity

Start date: February 5, 2021
Phase:
Study type: Observational

Recently, an association between active inflammatory bowel disease (IBD) and poor sleep quality has been proposed; however, the causal relationship has not yet been established. This study aimed to investigate prevalence of poor sleep quality in IBD and association with disease activity by subjective and objective measures. Prospective observational study is conducted with expected sample size of 100 patients. Participants are classified into active and inactive disease status according to standard IBD severity assessment measures. Demographic data, disease activity, quality of life, sleep questionnaire (validated PSQI questionaire), and seven-day sleep data acquired from ambulatory wrist actigraphy were obtained. Association between sleep quality and disease activity will be analyzed.

NCT ID: NCT05526170 Recruiting - Atrial Fibrillation Clinical Trials

Triggers and Risk Factors for Recurrence of Atrial Arrhythmias With the Use of Long-term Monitoring

TriggersAF
Start date: August 1, 2021
Phase:
Study type: Observational

A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. The collected data of personalized triggers and risk factors will be used to define the individual phenotype of atrial arrhythmia.

NCT ID: NCT05521243 Completed - Sleep Clinical Trials

An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity

Start date: May 9, 2022
Phase: N/A
Study type: Interventional

This double-blind study will examine the effectiveness of Dream Powder and Dream Powder Extra Strength over a six week period. The main outcomes of interest will be sleep quantity and quality, as well as self-reported changes in sleep across the study period.

NCT ID: NCT05516524 Recruiting - Clinical trials for Sleep Apnea, Obstructive

HSAT for OSA Management in Children

HOM-Kids
Start date: December 1, 2022
Phase: N/A
Study type: Interventional

This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children

NCT ID: NCT05515055 Recruiting - Addison Disease Clinical Trials

Does Relative Hypoglycaemia &/or Sleep Disturbance Contribute to the Lethargy Observed in Addison's Disease

Start date: April 7, 2022
Phase:
Study type: Observational

Addison's disease is a condition that leads to a reduction in production of steroid hormones from the adrenal glands. These hormones, particularly cortisol have many important roles in the body, one of which is increasing blood sugar. These steroids will be replaced with tablets but fails to mimic the normal increase in natural cortisol levels which increase from around 2am in the early morning. Furthermore, steroid tablets have been associated with stopping patients from going to sleep. Patients with Addison's disease on treatment still complain of excessive fatigue and have an increased risk of death from blood vessel diseases. Some case reports have shown some patients with Addison's disease to have low blood sugars overnight. To investigate the possible causes of fatigue in Addison's disease by examining sugar levels and sleep patterns of our patients. Blood clotting will also be looked at as a potential mechanism for the unexplained increase in blood vessel diseases. To examine sugar levels a small probe will be attached to the upper arm which the patients will wear for 14 days to measure blood glucose very regularly and is painless. Additionally the patients will wear a watch that monitors sleep, movement, and light. A single blood sample will be taken to measure vascular risk markers and how the blood clots. After wearing the monitors the subjects will complete questionnaires assessing quality of life. Healthy individuals will be recruited to undergo the same monitoring to act as a control group. The data data obtained between Addison's disease and healthy subjects will be compared. The scores from the questionnaires will be compared to the glucose and sleep readings to ascertain if there is a link between low blood sugars or sleep disturbance and their quality of life to determine if any physical abnormalities translate in to the poor quality of life.

NCT ID: NCT05511818 Completed - Sleep Clinical Trials

Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes

Start date: September 12, 2022
Phase: N/A
Study type: Interventional

A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes

NCT ID: NCT05489653 Terminated - Parkinson's Disease Clinical Trials

Mixed Music Intervention on Sleep Disturbance in Patients With Parkinson's Disease

Start date: November 10, 2022
Phase: N/A
Study type: Interventional

Parkinson's disease is a disease that is prevalent in the elderly, and the risk increases with age. Sleep disturbance is a common complaint of patients with Parkinson's disease, with a prevalence of 60% to 96%. Long-term sleep disturbance in Parkinson's disease patients significantly reduces cognitive function and quality of life. Nursing staff are the first line of care and should seek appropriate strategies to address sleep disturbances in patients with Parkinson's disease. This study is a feasibility and pilot study, which will be a single-blind, parallel randomized controlled trial. It is expected to include 30 patients with Parkinson's disease with poor sleep quality, and they will be equally allocated to the mixed music group (10 people), passive music group (10 people), and usual care group (10 people) in a 1:1:1 ratio. If assigned to the passive music group, they are required to listen to soft and low-pitched music at about 60 beats per minute for 30 minutes before sleep every day for four weeks. If assigned to the mixed music group, in order to synchronize active daytime music and passive music at bedtime, active daytime music will require patients to perform physical music activities once a week and watch a recorded music intervention video three times a week during the study period (The content is the same as the physical music activities) and follow the activities, and the intervention content before going to bed is the same as the intervention content of the pure passive music group. Subjects assigned to the usual care group maintained their original lifestyle and were assisted by study evaluators to complete pre-and post-test data. The researchers will establish a line group, and the three groups of patients or primary caregivers will be contacted by line every two days to care for the patient's condition. The variables measured included anxiety, depression, quality of life, and sleep quality, as assessed by the Hospital Anxiety and Depression Scale, Parkinson 's Disease. Questionnaire - 39, and the Pittsburgh Sleep Quality Scale . This study will use one-way ANOVA and linear mixed model for statistical analysis to test the hypothesis of this study. If the effectiveness of this intervention can be confirmed, it will be implemented in Parkinson's disease patients in the future to reduce sleep disturbances and improve patients' quality of life.