Active clinical trials for "Sleep Wake Disorders"

Sleep disorders are highly prevalent all around the world and have a strong negative impact on quality of life (QoL). In Colombia, up to 60% of adults report any sleep disturbance and more than 45% have required medical assistance for this. There is abundant anecdotal and scientific evidence supporting the efficacy and safety of several plant extracts on sleep quality. In this context, the development of safe and effective natural products may have a positive impact on sleep and general QoL.

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.

Accuracy evaluation of EarlySense device, a smaller shape sensor with BLE connection to processing unit (HUB)) for use while two people are in bed ("Home Use" scenario) The EarlySense device is intended for continuous contact-free monitoring of heart rate and respiration rate at home, or in professional healthcare settings. The system is intended for remote monitoring of patients by healthcare professionals and is indicated mainly for elderly population monitoring. The modified version of this product which is the subject of this validation study allows monitoring of subjects when there is a second person in the same bed ("Home scenario" environment). The objective of this study is to evaluate the accuracy of the device in determining Respiration Rate (Br./min) and Heart Rate (BPM) at home environment, while two people are in the same double bed. The study aims to demonstrate that partner presence doesn't affect the monitoring accuracy of the subject that is being measured. The continuous monitoring will last for duration of 90 minutes for each subject, unless the participant requests termination of the experiment or as per the physician's instructions. Subjects admitted to the study will be monitored using both Capnography and ECG- as reference devices. The EarlySense revised sensor will be placed under one of the two-mattress types incorporated into the study. Both mattresses are typical double bed mattresses of 160 X 200 cm with two different internal structure composition. The sensor will be placed directly below the subject's thorax area on one of the mattress sides. The signals collected by the sensor will be communicated via BLE to the processing unit (HUB). Following connecting the subject to the reference devices, both the subject and the partner will be instructed on the actions they should perform through the stages of the experiment. The subject will lie on the mattress side where the EarlySense sensor is located, while the partner will be instructed to enter the other side of the mattress. At this time, the experiment will start, and the clock will start running.

Study objectives are to determine the efficacy, safety and tolerability of bright light treatment in Parkinson's Disease (PD) patients with daytime sleepiness. Thirty PD patients will be enrolled and equally randomized to bright light or dim-red light treatment. Objective (actigraphy) and subjective (sleep logs/scales) sleep measures will be collected through the baseline and intervention phases of the study. The primary outcome measure will be the change in the Epworth Sleepiness Scale (ESS) comparing the bright light treatment with dim-red light treatment. Secondary outcome measures will include the Multiple Sleep Latency Test (MSLT), global Pittsburgh Sleep Quality Index (PSQI) score, Parkinson's Disease Sleep Scale (PDSS) score, and actigraphy measures. A variety of exploratory analyses will examine the effects of bright light treatment on fatigue, depression, quality of life, cognition, and motor disability. Hypothesis: Bright light exposure will diminish daytime sleepiness and improve night-time sleep in PD patients with daytime sleepiness.

The aim of this study is to examine if repetitive computerized cognitive training improves working memory in patients who are on sick leave due to complex symptom disorders (chronic pain, chronic fatigue, anxiety, depression and or sleep disorders), and whether effects of cognitive control training transfer to other tasks.

Although behavioral disorders origins in autistic children are still unclear, they seem to be influenced by sleep disorders. Results of studies performed on sleep quality in autistic children showed a high prevalence of sleep disorders in these children, estimated between 50 and 80% compared to children with typical development and insomnia is one of the sleep disorders most frequently reported by autistic children's parents. Others studies showed circadian rhythm disorder in autistic children which could be the consequence of genetic abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission modulation. Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of sleep proposed for insomnia treatment and circadian rhythm disorders. Two major recent studies (not yet published) in the United States and in England seek to show the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing sleep disorders. It is therefore interesting and important to conduct a parallel study to assess the melatonin effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time…), but on sleep quality (number of nocturnal awakenings). The strength of this study lies in the combination of several measurement tools to assess the melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography), biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of insomnia severity, rating scale autistic disorder) as well as possible side effects. The primary objective is to determine the most effective dose of melatonin to improve sleep quality in autistic children.

Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance. The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia. The effects of the treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be examined. A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF self-management education. Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete self-report measures of insomnia, sleep, symptoms, and functional performance. In addition the effects on symptoms and function over a period of one year.

The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and additional parameters in children with neurodevelopmental disabilities. The efficacy and safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period of 13 weeks.

The purpose of this study is to study the differential short-term effect of nocturnal oxygen, acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms, exercise capacity and nocturnal breathing disturbances in subjects with pulmonary hypertension and sleep related breathing disorders Trial with medicinal product

The major goal of this project is to investigate established insomnia treatments in a schizophrenia population to see if the improved sleep leads to overall better quality of life. In addition, we hypothesize that the insomnia treatment may also lead to observed improvements in other symptoms associated with schizophrenia such as cognitive impairments, obesity, and negative symptoms.