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Sleep Disorder clinical trials

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NCT ID: NCT06378034 Not yet recruiting - Sleep Disorder Clinical Trials

Effect of Lactium on Sleep Disorders in Healthy Volunteers With Persistent Subclinical Insomnia

Start date: June 10, 2024
Phase: N/A
Study type: Interventional

The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia.

NCT ID: NCT06260020 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Development and Validation of a Comprehensive Module for Management of Sleep Disorders in ASD Children

Start date: February 20, 2024
Phase: N/A
Study type: Interventional

Sleep disorder in autism children is common and it affects the physical, behavior and mental health. There is lack of comprehensive management program/module to treat the sleep disorders in children with ASD. Limited studies evaluating the utility of actigraphy to diagnose sleep disorders in ASD and its validation with PSG are present. Rationale of this study is to develop the comprehensive module and validate it for children with autism spectrum disorders, so as to improve the behavioral outcomes as well. This study also helps to utilize actigraphy as a modality to diagnose sleep disorders in children with autism spectrum disorder as performing PSG in these children is cumbersome and difficult as ASD children tend to have sensory abnormalities.

NCT ID: NCT06221865 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Study of the Correlation Between Post-traumatic Stress Disorder and Paradoxical Sleep Behavior Disorder

TRAUMA-TCSP
Start date: January 15, 2024
Phase:
Study type: Observational

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).

NCT ID: NCT06117969 Not yet recruiting - Menopause Clinical Trials

the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

Start date: December 30, 2023
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT06012513 Not yet recruiting - Sleep Disorder Clinical Trials

Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis

Start date: September 2023
Phase:
Study type: Observational

1. To determine sleep disturbance in different types of multiple sclerosis. 2. To asses the effect of sleep disturbance on quality of life in patients with multiple sclerosis. 3. Correlation between sleep disturbance in different types of multiple sclerosis.

NCT ID: NCT05960513 Not yet recruiting - Depression Clinical Trials

Impact of Breathing Exercises and Meditation on Improving Quality of Life in Glaucoma Patients

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

Glaucoma is a chronic disease that causes loss of vision and potentially blindness as a result of optic nerve damage, often due to increased intraocular pressure. Glaucoma is currently the leading cause of irreversible blindness worldwide.1 In 2020, 4.1 million and 3.6 million adults over the age of 50 suffered from mild to severe glaucoma-induced visual impairment and blindness, respectively.1 However, these figures are likely underestimated since glaucoma can remain asymptomatic until later stages in disease progression.2 The relaxation response evoked by mind-body interventions, such as breathing exercises and meditation, is known to reduce stress and improve quality of life (QOL). In a recent study, mindfulness-based meditation was found to reduce intraocular pressure and improve QOL in patients with glaucoma.3 A feasibility study will be conducted using a mixed-method design to assess the feasibility of the online delivery of an intervention titled Breathing Exercises followed by Meditation for potentially enhancing the QOL and mental health of glaucoma patients. Upon recruitment, participants will undergo blocked randomization to either the intervention arm or usual care arm, stratified by sex. Participants in each arm will complete online questionnaires at baseline and after 12 weeks to collect data on health-related quality of life (HRQOL), depression symptoms, anxiety, and sleep quality using REDCap, an electronic data capturing system provided by Lawson Health Research Institute (LHRI). Our study can help to assess the feasibility of conducting a pilot study on breathing exercises followed by meditation to assess its effects in a sample of patients with glaucoma.

NCT ID: NCT05950932 Not yet recruiting - Anxiety Clinical Trials

Effects of Melissa Extract on Sleep Characteristics

Start date: September 2023
Phase: Phase 4
Study type: Interventional

The plant Melissa officinalis L. is commonly used to treat disorders related to anxiety and sleep quality. It contains several phytochemicals that give it antioxidant, anti-inflammatory, antispasmodic, antimicrobial, and neuroprotective properties. A study on subjects with mild to moderate anxiety and sleep disorders showed that an extract of Melissa officinalis reduced anxiety manifestations by 18%, improved symptoms associated with anxiety by 15%, and reduced insomnia by 42%. However, that study did not have a control group, so a randomized trial with a control group is needed. The objective of the study will be to evaluate the beneficial effects of a phytosome-formulated Melissa officinalis extract on sleep duration and different stages of sleep, which will be monitored using a wrist device. She will be provided with a wrist device that will be used for sleep monitoring. The trial will last for 45 days, in which she will be asked to take the phytosome-formulated Melissa supplement for two 14-day periods (2 tablets, 30 minutes before bedtime). There will be a 7-day break in the intake period between the two periods. At the beginning, middle, and end of the trial, you will be asked to answer some questionnaires.

NCT ID: NCT05697094 Not yet recruiting - Depression Clinical Trials

Impact of Meditation on Improving Quality of Life Among Glaucoma Patients: An Electronic Pilot Feasibility Study

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

Glaucoma is a chronic disease that causes loss of vision and potentially blindness as a result of optic nerve damage due to increased intraocular pressure. Currently, it is the leading cause of irreversible blindness worldwide1. In 2020, 4.1 million and 3.6 million adults over the age of 50 suffered from mild to severe visual impairment and blindness respectively induced by glaucoma1. However, these predictions are likely underestimated since glaucoma can remain asymptomatic until later stages in disease progression2. There is a convincing body of evidence suggesting that there is a linear relationship between visual impairment and decreased quality of life (QOL) among glaucoma patients3. Furthermore, evidence from The National Health and Aging Trends Study suggests that this relationship may be bidirectional where older adults with visual impairment are more likely to suffer from mental illness and older adults with mental illness are more likely to suffer from visual impairment4. Mindfulness-based meditation is a promising non-pharmacological treatment that has been shown to reduce intraocular pressure and improve QOL in patients with glaucoma5. A feasibility study will be conducted using a mixed-method design to assess the feasibility of delivering a meditation intervention online to enhance the QOL and mental health of glaucoma patients. Participants will be recruited and randomized in blocks of 10 and will undergo 1:1 randomization to the intervention arm or usual care arm. The purpose of this block randomization technique is to minimize the wait time between patient recruitment and study initiation. Participants in each arm will complete online questionnaires at patient recruitment, weeks 1, 3, 6, and 12 to measure self-reported health, depression symptoms, anxiety, and sleep quality using REDCap, an electronic data capturing system provided by Lawson Health Research Institute (LHRI).

NCT ID: NCT05696496 Not yet recruiting - Sleep Disorder Clinical Trials

Evaluation of e New Sleep Detection Device "Easy Sleep Monitoring"

ESM
Start date: January 20, 2023
Phase: N/A
Study type: Interventional

If the video-polysomnographic (vPSG) recording in the laboratory remains the reference examination in Sleep Medicine Centers for the diagnosis of sleep pathologies, the high prevalence of sleep disorders in the general population and the growing demand for exploration and management may require the use of alternative techniques such as new sleep recording or analysis devices. In collaboration with the Creative Mechatronics Company (Issoire) and the Ennery Confection Company (Le Puy en Velay), we have developed a "portable" sleep detection prototype called Easy Sleep Monitoring (ESM) which consists of an "intelligent" duvet equipped with a series of sensors capable of detecting movements and, through this, estimating sleep duration and quantifying motor phenomena during sleep. Indeed, it is a duvet which has in its thickness a grid of 35 electronic cards, equipped with an actimetric sensor and a temperature sensor. The distribution of the sensors makes it possible to detect the motor activity of the sleeper on all the body regions by considerably increasing the sensitivity and specificity compared to actimetry at the wrist. The advantage of this duvet compared to other "wearable" devices is represented by its ease of use, being less restrictive, having a reduced implementation time and not requiring the user's collaboration. For example, it could be used for sleep monitoring in the elderly and/or in a situation of hypomobility in the context of Residential establishment for dependent elderly people or hospitals. At home, it could be a sleep monitoring tool, such as monitoring treatment for insomnia, medicinal or not, or to monitor motor activity during sleep, as in the monitoring of nocturnal akinesia in parkinsonian patients. The main objective of this study is to evaluate the concordance of sleep data obtained with the ESM duvet with those obtained by video-polysomnography (vPSG). Indeed, the vPSG is the gold standard examination in the study of sleep, the only one capable of exactly defining the different stages of sleep and precisely quantifying sleep disorders.

NCT ID: NCT05649514 Not yet recruiting - Cognitive Decline Clinical Trials

Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease

WAVE-APOE4
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Alzheimer's disease (AD) is characterised by a progressive loss of memory and cognitive function. In the early stages of AD, there is a progressive accumulation of molecules: β-amyloid peptides (Aβ) in the brain. There is a link between the accumulation of Aβ peptides and the deterioration of sleep, but current knowledge does not confirmed this link. The objective of this study is to define whether there is a link between cognitive decline and sleep disorders. If a correlation is found, this could allow earlier treatment of sleep disorders in the longer term in order to slow the development of AD. Treatment protocols in the field of Alzheimer's disease (AD) are directed towards participants at risk of developing the disease, such as those who carry at least one ε4 allele on apolipoprotein E (APOE ε4). An individual with 2 ε4 copies has a 30-55% risk of developing AD with an age of onset around 68 years and a dose effect of the allele on risk and age of onset of symptoms.