View clinical trials related to Sleep Disorder.
Filter by:The study is a comparative, self-controlled, randomized, prospective investigation designed to assess the usability and accuracy of the DormoTech Vlab and compare its performance with a full polysomnography (PSG) study conducted over one night in a sleep lab. For the purpose of this study, the selected PSG device used for comparison is the Nox A1 system (K192469). Participants were required to wear the DormoTech Vlab, answer questionnaires pre and post-study, and simultaneously undergo a full PSG test using the Nox system. The statistical methodology for this study was designed to ensure a comprehensive analysis of the data, adhering to the standards set by the International Council for Harmonisation (ICH) E3 guideline
The preservation surgery of the anal sphincter muscle has become the standard procedure in the treatment of rectal cancer and, thanks to advancements in surgical techniques, can now be performed for tumors located closer to the anus. This method allows patients to avoid a permanent artificial anus, maintaining continuity of the intestines and enabling bowel movements through the anus, making it a highly preferred procedure. Furthermore, advancements in various tumor treatments have led to improved long-term survival rates. Preservation surgery of the anal sphincter muscle is commonly used in the treatment of rectal cancer, resulting in approximately 90% of patients experiencing changes in bowel habits after surgery. These changes include characteristic diarrhea, urgent bowel movements, frequent bowel movements, and fecal incontinence, collectively known as Anterior Resection Syndrome (ARS). Particularly in the case of low rectal cancer, it often manifests as Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, generally persisting in a significant degree for 1-2 years, with some improvement over time. However, for many patients, LARS remains a lifelong challenge, significantly impacting their quality of life. Nighttime symptoms of LARS, in particular, have a profound effect on sleep quality, potentially leading to a decline in overall quality of life. Currently, there is no definitive method to completely cure LARS, and the available approaches focus on empirical treatments or short-term symptom control using medications such as loperamide. Loperamide directly affects the neuromuscular system of the intestine, reducing its motility. This prolongs the time food stays in the intestine, allowing sufficient absorption of moisture and electrolytes, consequently reducing symptoms of diarrhea. Loperamide is available in two forms: loperamide oxide and loperamide hydrochloride. While loperamide oxide products like Arestal® were prescribed by doctors until August 2017, the approval was revoked, leaving loperamide hydrochloride as the only form used domestically. It comes in a single product containing 2 mg of loperamide hydrochloride and a combination product with 0.25 mg of loperamide hydrochloride, a sterilizing agent in the intestine (e.g., acrylonitrile, berberine), and an antispasmodic. Transanal irrigation (TAI) is a method where patients self-administer water into the rectum through an enema, physically cleansing the anus and rectum. This technique is often used for patients with chronic constipation or fecal incontinence. TAI has proven beneficial, particularly in improving symptoms for patients experiencing bowel dysfunction following sphincter-preserving surgery, especially for those who underwent low anterior resection. However, there is currently no research on the utility and safety of TAI for LARS patients, specifically addressing whether it can improve the nighttime symptoms associated with LARS syndrome and enhance sleep quality. Therefore, this study aims to investigate the impact of TAI on the quality of sleep in patients with nighttime symptoms of LARS syndrome.
Post-Traumatic Stress Disorder is a psychiatric disorder that occurs after a traumatic event and is estimated to affect 5 to 12% of the general population. Around 70% of patients suffering from this disorder report sleep disorders (sleep apnea, insomnia, recurring nightmares, etc.). There are specific sleep disorders called Rapid Eye Movement (REM) sleep behavior disorders which correspond to nocturnal restlessness with sometimes violent behavior, often associated with intense dreams during a phase of sleep called REM sleep. These disorders are more frequently found in patients suffering from post-traumatic stress, such as veterans. However, the physiopathological link between these two disorders is poorly understood and studies on this subject are few in number. Through this study, the investigators wish to demonstrate whether there is a correlation between the severity of Post-Traumatic Stress Disorder and that of Rapid Eye Movement sleep behavior disorder. The main objective is to study the relationship between the severity of Post Traumatic Stress Disorder (PTSD) and the Rapid Eye Movement (REM) Sleep Behavior Disorder. This is an observational prospective study based on 4 questionnaires relating to the sleep (PSQI), the severity of the Rapid Eye Movement (REM) Sleep Behavior Disorder (REM RBDSQ, IRBD-SSS) and the severity of the Post-Traumatic Stress Disorder (PCL-5).
This single arm clinical trial will assess whether continuous positive airway pressure (CPAP) therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among para-athletes living with cervical/thoracic, complete or incomplete spinal cord injury (SCI) is effective in improving cognitive impairment, in reducing fatigue, depression, anxiety, and overall quality of life. Further, the study will evaluate the effectiveness of CPAP therapy in improving their performance in sports and the perceived risk of injuries.
Objective: Sleep and behavioral problems are common in infants at risk of autism. This study aims to examine the effect of Snoezelen-Based Occupational Therapy intervention on sleep and behavioral problems in infants at risk of autism. Design: Twenty-four infants (15 boys, 9 girls) at risk for autism were randomized to the intervention group (n = 12; 28.33 ± 6.52 months) and the control group (n = 9; 30.11 ± 5.20 years). The intervention group received Snoezelen-Based Occupational Therapy intervention in addition to the conventional 8-week sensory integration intervention, while the control group received only the conventional sensory integration intervention. Both groups assessed sleep and behavioral problems using the Brief Infant Sleep Questionnaire (BİSQ) and the Vineland Social-Emotional Early Childhood Scale (VSEES) pre and post eight weeks of intervention.
The goal of this clinical study is to study sleep and its microstructure in neuropathic pain patients who have or who do not have a clinically significant sleep disturbance, before and during (after 1-month stabile dosage) pregabalin treatment. To find out whether reduced pain by pregabalin associates with improved sleep quality; to study, using resting state fMRI, brain network connectivity and the volume of the choroid plexus before and during pregabalin treatment (after dosage stable for one month) at baseline and during stabile treatment with pregabalin, and to compare the usability and reliability of sleep-related information collected with sleep diaries, actigraphy, iButtons, and ambulatory polysomnography in peripheral painful neuropathy patients. The main questions it aims to answer are: - Is pregabalin more efficacious in neuropathic pain patients who suffer from insomnia compared to those with no clinically meaningful sleep disturbance? - Does sleep disturbance due to pain associate with brain network connectivity and may these changes be reversed by pregabalin treatment? Participants will - Fulfill e-questionnaires and keep sleep diary before and after 1month stabile pregabalin intervention - Before and after 1-month stabile pregabalin medication: 1-week Actiwatch monitoring, iButton (1 day and night), ambulatory polysomnography (1 night), brain fMRI. Researchers will compare patients with high ISI score patients to see if they benefit more from pregabalin treatment than those with low ISI score.
Some people experience a temporary change in behaviour and consciousness, that often involves a collapse and/or shaking limb movements. These are referred to as 'Dissociative seizures'. Those who experience such seizures have been found to also display high levels of dissociation, which can be described as a change in your conscious experience and may include gaps in your memory for events. It is thought that people who experience dissociative seizures also often have difficulties with their sleep. Having difficulties with sleep may make these seizures and the amount of dissociation an individual experiences worse. Greater dissociation may be additionally linked to worsening dissociative seizures. A psychological treatment for sleep difficulties called Cognitive Behavioural Therapy for Insomnia (CBTi), has been found to be effective in reducing sleep difficulties. The main questions this study aims to answer are: 1. Does brief CBTi (bCBTi) improve sleep difficulties in those with dissociative seizures? 2. Does bCBTi reduce the frequency of dissociative seizures? 3. Does bCBTi reduce self-reported levels of dissociation in participants? 4. Does improving sleep difficulties lead to improvements in quality of life, mood and anxiety levels? 5. Is bCBTi a feasible intervention to administer in an inpatient setting? This study will investigate whether improving sleep by administering a brief version of CBTi leads to an improvement in levels of dissociation and dissociative seizure frequency. It will also investigate whether brief CBTi is a feasible treatment method for sleep difficulties in an inpatient setting. Participants who have dissociative seizures and sleep difficulties that could be diagnosed as insomnia will be randomly assigned to a baseline phase of 5, 7 or 9 days, where they will fill out daily questionnaires on their sleep, dissociation and number of seizures. They will then begin a 10-day intervention phase where they will attend two sessions of brief CBTi, whilst also completing daily measures. This will allow us to see whether their scores on the sleep and dissociation measures improve when the intervention begins. Participants will be asked to wear an Actiwatch during the night, to gather information on their movement levels during the night. Information on changes in quality of life, mood and anxiety levels following the sleep intervention will also be collected.
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.
Sleeping disorders are one of the most common menopausal symptoms, which seriously affect health and life quality of perimenopausal women. Menopausal hormone therapy is an effective treatment for menopausal symptoms, meanwhile, traditional Chinese medicine is also effective to some extent. This prospective randomized controlled study plan to compare the effects of different therapy regimens, including Tibolone and Xiangshao granules, on menopausal sleep disorders.
In order to assess the efficacy of the rhythm stabilization component of Health Rhythms' product in addressing sleep problems, investigators will recruit 128 outpatients over the age of 18, who are in early recovery (at least 2 weeks but no more than 6 months) from Alcohol Use Disorder (AUDIT-C score >4) and are experiencing sleep problems (ISI score >/= 10). 64 of these individuals will be randomly allocated to receive the full HealthRhythms package (sensing, trending, and stabilization) on their smartphones, while 64 will be asked to consent to sensing only. The duration of the study will be 14 weeks. The primary outcome measures of the RCT will be the ISI (Insomnia Severity Index). The investigators hypothesize that those receiving the full package will demonstrate lower levels of sleep disturbance.