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NCT07315516
The goal of this clinical trial is to learn if natural supplements (lavender oil, PEA, and OEA) work to improve sleep and reduce stress in adults with moderate stress levels and sleep difficulties. It will also learn about the safety of these natural supplements. The main questions it aims to answer are: * Do these supplements improve sleep quality? * Do they reduce perceived stress levels? * Do they reduce anxiety symptoms? * What medical problems do participants have when taking these supplements? Researchers will compare three active treatment groups (lavender oil, PEA, Trpti which contains OEA) to a placebo (a look-alike capsule that contains no active ingredients) to see if these natural supplements work to improve sleep and reduce stress. Participants will take 1 capsule (either active supplement or placebo) every day for 8 weeks and attend 2 clinic visits with a phone check in in between.
NCT07444372
Atrial fibrillation (AF) is one of the most common clinical arrhythmias. Catheter ablation is an effective therapeutic strategy; however, recurrence rates remain substantial, ranging from 20% to 45%. Previous studies have established a strong association between obstructive sleep apnea (OSA) and the risk of AF recurrence following ablation. While continuous positive airway pressure (CPAP) is the standard intervention for OSA, and some observational studies suggest it may reduce post-ablation recurrence in patients with comorbid OSA, small randomized controlled trials have failed to confirm a clear benefit, potentially due to poor adherence. This study aims to evaluate the clinical benefit of post-ablation CPAP therapy in AF patients with comorbid OSA. Participants will: * Be randomly assigned to either the CPAP group or the usual care group. * If in the CPAP group, use a CPAP device for 12 months. * Wear an ambulatory ECG recorder for a 7-day period at 3, 6, 9, and 12 months post-operation. * Complete follow-up checkups either at the clinic or over the phone at 1, 3, 6, and 12 months after their procedure.
NCT07432828
The goal of this observational study is to validate a simplified questionnaire, adapted for routine clinical use, to quickly detect sleep disorders in patient during a cardiology consultation. Two questionnaires were developed for this project. The first is patient-oriented: a prospective, multicentre, national observational registry based on a patient questionnaire designed to quickly detect sleep disorders during a cardiology consultation. The second is aimed at treating cardiologists: this is a simple impact survey designed to assess changes in the practices of cardiologists who participated in CARDIOSOM.
NCT07425964
The goal of this clinical trial is to learn whether sleep hygiene education can improve sleep quality and reduce pain in adults with migraine and/or chronic lower back pain. Poor sleep is common in people with chronic pain and may worsen symptoms. Improving sleep may help break this cycle. The main questions this study aims to answer are: 1. Does a four-week sleep hygiene education program improve sleep quality? 2. Does improved sleep lead to reduced pain intensity and changes in pain sensitivity? This study does not include a comparison group. Each participant serves as their own comparison by completing the same tests before and after the sleep hygiene program. Participants will: * Attend two study visits lasting 30-60 minutes, one at the beginning and one after four weeks * Complete questionnaires about sleep, pain, mood, and quality of life at both visits * Undergo pain sensitivity testing using light pinprick stimulations on the forearm * Receive individual sleep hygiene education and written materials to use at home for four weeks * Complete a short weekly online check-in about sleep habits and pain * Complete a three-month follow-up questionnaire about sleep habits, sleep quality, and pain
NCT07144631
The goal of this study is to evaluate whether peroneal electrical nerve stimulation (PNS) using the TOMAC™ device is a feasible, acceptable, and safe non-pharmacologic intervention for managing Restless Legs Syndrome (RLS) during pregnancy. This pilot study will also collect preliminary information on symptom relief, sleep quality, and maternal-fetal safety associated with device use. The main questions the study aims to answer are: Is TOMAC™ PNS a feasible and acceptable intervention for RLS in pregnant individuals? Are there any maternal, fetal, or neonatal safety concerns with PNS use during pregnancy? What are the patterns of adherence, tolerance, and usability of the TOMAC™ device in this population? Participants will: Use a non-invasive TOMAC™ peroneal nerve stimulator during 30-minute sessions as needed, for 8 weeks. Complete questionnaires assessing feasibility, acceptability, symptom severity, and sleep quality (including AIM, IAM, FIM, IRLS, PGI-I, PSQI, ESS, FOSQ, and MOS-II). Wear an actigraphy monitor to collect objective sleep data at baseline and at 4 weeks. Attend scheduled follow-up visits and phone check-ins for maternal vital signs, uterine contraction and fetal monitoring, and neonatal outcome assessment. This is a prospective, open-label, single-arm pilot study enrolling 15 pregnant participants between 21 and 26 weeks' gestation. Findings will provide the first dataset on the feasibility, acceptability, and safety of TOMAC™ PNS in pregnancy and inform the design of a future randomized controlled trial.
NCT07122388
This retrospective observational study is designed to investigate sleep patterns, as well as both the macrostructure and microstructure of sleep, in a large cohort of children and adolescents diagnosed with Autism Spectrum Disorder (ASD). The study will utilize data derived from overnight polysomnographic recordings, providing objective and comprehensive measures of sleep architecture. The sample consists of 187 patients, aged between 3 and 16 years, whose sleep data were collected over a ten-year period, from 2003 to 2013. In addition to polysomnographic parameters, the study will incorporate a wide range of behavioral and parental stress-related variables. These will be assessed using validated, standardized instruments, including the Sleep Disturbance Scale for Children (SDSC), Autism Diagnostic Interview-Revised (ADI-R), Autism Diagnostic Observation Schedule-2 (ADOS-2), Child Behavior Checklist (CBCL), and the Parenting Stress Index - Short Form (PSI-SF). By integrating objective sleep data with behavioral and psychosocial measures, this study aims to provide a more nuanced understanding of the nature and extent of sleep disturbances in individuals with ASD. Particular attention will be paid to identifying potential correlations between specific sleep alterations (e.g., changes in sleep efficiency, REM latency, arousals, or cyclic alternating patterns) and behavioral symptoms or parental stress profiles. Ultimately, the findings are expected to contribute to the development of more precise and individualized diagnostic frameworks, as well as inform evidence-based therapeutic strategies. These insights could be of considerable clinical relevance, given the high prevalence of sleep disorders in the ASD population and their significant impact on daytime functioning, emotional regulation, and family quality of life.
NCT07019948
In this study, medical staff in emergency and critical care departments were investigated. It was assumed that the use of sleep aids and dietary patterns affected their sleep quality. The structural equation model was used to analyze the status of sleep quality of medical staff in emergency and critical care departments, and to explore the effects of sleep aids and dietary patterns on sleep quality and its mechanism. ( 1 ) Is the overall sleep quality of medical staff in emergency and critical departments poor ( 2 ) Do medical staff with poor sleep quality in acute and critical departments use sleep aids more frequently ( 3 ) Is there a correlation between sleep quality and certain dietary patterns among medical staff in emergency and critical care departments ( 4 ) Are there significant differences in dietary choices among medical staff in emergency and critical departments using sleep aids
NCT06878690
Specific learning disorders, or SLD, are cognitive and behavioral conditions that emerge during childhood and involve significant difficulties in acquiring and performing specific intellectual, motor, language, and social functions. These disorders impact personal, social, academic, and professional functioning throughout life. In France, between 6% and 8% of the population, including both children and adults, are affected by at least one type of SLD. SLD are also frequently associated with Attention Deficit Hyperactivity Disorder (ADHD), with prevalence rates ranging from 33% to 70%, depending on the study. This comorbidity leads to more severe attention and learning difficulties than when ADHD or SLD occur independently. ADHD is a common neurodevelopmental disorder that affects cognitive attentional processes, with or without hyperactivity. It is estimated to affect approximately 5.3% of children and adolescents worldwide and about 3% of adults. The assessment of these disorders is conducted through a neuropsychological evaluation, which determines the type and severity of cognitive impairments. Several studies report that 55% to 74% of children with ADHD experience sleep difficulties. To date, only two studies have examined the prevalence of sleep disorders among children with SLD disorders. One of these studies focused exclusively on dyslexia, with or without ADHD. The results revealed significantly higher scores among dyslexic children compared to controls when completing sleep disorder assessment questionnaires (SDSC). The main difficulties were related to "sleep onset and maintenance disorders," "sleep-related breathing disorders," and "wakefulness disorders." The second study, using the same questionnaire, compared children with ADHD, SLD disorders, and both combined. The group with co-existing SLD and ADHD disorders exhibited significantly more sleep disturbances than the other groups, primarily sleep onset and maintenance disorders. Despite the importance of these studies, they focused only on sleep disorders associated with dyslexia, without considering other learning disorders such as dyspraxia, dyscalculia, or dysgraphia. Furthermore, when ADHD was taken into account, the studies did not differentiate between its various forms, limiting the interpretation of the results. Additionally, no research has tracked the evolution of sleep disorders in the SLD +/- ADHD population from childhood through adolescence and into adulthood. In this study, the investigators aim to evaluate sleep disorders in the SLD population (with or without ADHD) in France through online questionnaires. These questionnaires will be offered to 1,000 children (aged ≥4 years) and adults diagnosed with at least one specific learning disorder. Primary Objective: The main objective of this study is to assess the frequency and nature of sleep disorders in patients (both adults and children) with specific learning disorders, with or without ADHD. Secondary Objectives: * Characterize the "SLD" patient population in France by considering age and gender: o Determine the prevalence of co-morbidities, such as: ADHD Anxiety and depressive disorders Other reported medical conditions * Assess the types of care provided (medication or other) for both children and adults * Determine the frequency of SLD in a familial context * Identify whether the following factors are associated with a higher frequency of sleep disorders: * Single SLD vs. multiple SLD * The presence of ADHD, anxiety-depressive disorders, or other medical conditions alongside SLD * Demographic characteristics (age, gender, etc.) * Family history of SLD among relatives (parents and siblings) * Medication use