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Sleep Disorder clinical trials

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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: February 1, 2023
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.

NCT ID: NCT05486039 Not yet recruiting - Sleep Disorder Clinical Trials

Adaptation of Mattresses Made With Different Materials to Personal Anthropometry Values and Body Postures

Start date: October 15, 2022
Phase:
Study type: Observational

Sleep disorders affect 40% of the adult population each year and are often associated with morbidity and mortality (Kripke et al., 2002; F.-Z. Low et al., 2017). Sleep quality plays a vital role in the overall quality of our lives. Therefore, a good sleep helps to create a quality life rhythm. A quality sleep reduces fatigue and increases physical regeneration (Khaleghipour et al., 2015). Poor sleep quality is due to various environmental factors such as temperature, light, noise and bed quality (Lei et al., 2009). It has been reported that 7% of sleep problems are caused by inappropriate mattresses that affect the load on the spine during sleep (F. Z. Low et al., 2017). Body contact pressure is a measure of the distribution of body weight across the body surface in contact with the mattress. A well-designed mattress usually has the ability to minimize high pressure points applied to the body. However, if the bed is not suitable for the person, pressure sores may develop in the body parts where pressure is intense (Cullum et al., 2004). The areas most affected by high pressure are usually the hips, shoulders and back, which can affect sleep quality and result in drowsiness or body stiffness throughout the day (Jacobson et al., 2002). A recent study by Bae and Ko compared the bed positions of hospital beds and found that a head-to-foot angle of 30° is the best position to reduce the likelihood of decubitus ulcers occurring in patients in high-pressure risk areas (Bae & Ko, 2013). In the light of previous studies, it has been observed that there is no study comparing many bed types designed using different materials for individual-specific postures. Biomechanical comparison of these bedding materials in individuals with different posture types and sleeping in different sleeping positions will allow us to provide new insights into their pressure distribution abilities. The aim of this study is to measure the effect of mattresses made of different mattress materials on body contact pressure profiles in individuals with different postures in various sleeping positions. It will be evaluated using maximum body pressure and pressure distribution as outcome measures.

NCT ID: NCT05325762 Not yet recruiting - Sleep Disorder Clinical Trials

Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders

Start date: December 1, 2022
Phase: Phase 4
Study type: Interventional

This study intends to conduct postoperative sleep intervention for elderly patients with sleep disorders undergoing surgery. We hope to explore whether propofol can improve the postoperative sleep quality of elderly patients with sleep disorders, prevent the occurrence of postoperative delirium in elderly patients, relieve patients' pain, promote patients' postoperative rehabilitation, and provide reference for realizing the rapid rehabilitation of elderly patients with sleep disorders through intravenous administration of research drugs, on the premise of improving patient comfort and ensuring patient safety.

NCT ID: NCT05237518 Not yet recruiting - Sleep Disorder Clinical Trials

Accuracy Evaluation of EarlySense With Modified Sensor (Smaller Shape Sensor With BLE) at Home Setting Monitoring a Subject While Partner in Bed

Start date: April 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04761809 Not yet recruiting - Sleep Disorder Clinical Trials

Sleep Duration, Chronic Insomnia, and Subjective Sleepiness in a Sample of Professional Flight Crews

SOMNAVI
Start date: March 2021
Phase:
Study type: Observational

Sleep is a physiological function that plays an essential role in many somatic, cognitive and psychological processes. Although there are many criteria for the effectiveness of sleep, its quantity is unanimously recognized as a major determinant of health. Too little sleep is associated with an increase in metabolic, cardiovascular and accidental morbidity and mortality caused by drowsiness while traveling or at work. Today, the time devoted to sleep is in competition with the time devoted to work, transport or new technologies, in a professional or recreational context. Faced with the public health issues thus raised, research has highlighted the interest of studying the relationships between sleep time and socio-demographic factors, beyond the mere involvement of sleep pathologies. However, among these pathologies, the role of insomnia is not negligible: it is in fact the most frequent sleep disorder (16% of French people in 2010) and represents an important source of involuntary reduction in sleep time, likely to increase inappropriate sleepiness during periods of wakefulness, in the context of activities sometimes involving safety. Flight crews are exposed to specific operational constraints, both in civilian and military environments, which may compromise the sleep recovery function (operational fatigue, extended work amplitudes, repetition of jet lag, etc.). These constraints, which are conducive to compromising the required levels of alertness and cognitive performance, are also at risk of cardiometabolic complications. They therefore raise the issue of risk control and maintenance of air safety. The issue of fatigue in pilots remains an essential issue for the safety of flight operations. Several determinants of operational fatigue in air transport have been identified, such as irregular sleep schedules, large, irregular, and sometimes unpredictable activity amplitudes, sleep debt, night flying, and circadian disruptions related to multiple and repeated time zone changes. While these factors have to deal with rules within airlines that are more often based on "work/rest" than "sleep/wake", current legislation and regulations in the aviation industry are now moving towards scientific approaches to fatigue management in commercial aviation, emphasizing the importance of sleep and taking circadian rhythms into account. In the wake of recent work carried out in the general French population, the conduct of a specific study on sleep time, prevalence and factors associated with chronic insomnia and the complaint of drowsiness among aircrew appears relevant. Due to the specific operational constraints mentioned above, chronic insomnia and sleep debt can be assumed to be more frequent among sailors than in the general population. A better consideration of certain sleep disorders in professional aircrew could allow the adaptation of prevention strategies or countermeasures aimed at optimizing the control of risks with regard to flight safety.

NCT ID: NCT04519177 Not yet recruiting - Sleep Disorder Clinical Trials

Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ...

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The investigators have shown that sleep health education and sleep disorders screening improve health and safety of employees. There is potential to increase the benefits of the sleep health education and screening program if more firefighters are evaluated, diagnosed and referred for treatment. Investigators will evaluate whether firefighters in stations randomized to participate in the Sleep Health and Education Program (SHEP) intervention will have improved health and safety outcomes as compared to firefighters in stations randomized to the control condition.

NCT ID: NCT04300166 Not yet recruiting - Sleep Clinical Trials

Telemedicine and Humidification for Cpap IN Osas Key Treatment (THINK Study)

THINK
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

The goal of the study is to test the role of telemedicine combined with humidification to check CPAP treatment during the first month to improve adherence and reduce unsolved side effects of therapy.

NCT ID: NCT04059419 Not yet recruiting - Osteoarthritis Clinical Trials

PARQUE 70+ Studying Sleep Disorder

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

The emerging Brazilian population is accompanied by the emergence of patients in an age group, including osteoarthritis. Osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases, affecting 4% of the Brazilian population. By 2050, 30% of Brazil's population is over 60 years old. This has a higher degree of elderly with morbades as unbass on the association, such as osteoarthritis. Proper management of OA involves educational program, multidisciplinary team care and therapeutic maneuvers with weight loss and maintenance of mobility. Insomnia is the most frequent sleep disorder in the elderly and its execution almost always harms young women. Sleep quality is interfered with fatigue and pain exacerbation in people with OA, ie a sleep approach should be diagnosed in patients with comorbidity. In addition, chronic patients usually have insomnia and pressure in the use of opioids, sedatives and antidepressants, pointing to insomnia and mood swings for polypharmacy. To evaluate a quality of sleep as an intervention of the PARQVE 70+ Project. Prospective, case-control study. Patients over 70 years old treated at a geriatric outpatient clinic with eye or polyarticular osteoarthesis and clinical OA treatment indicator will be allocated and matched in two groups of 30 elderly. Patients underwent Pittsburgh Sleep Quality Index questionnaires and the Epworth Scale before the study began, 3 and 6 months after PARQVE interventions and number of analysts, and compared those who did not perform an intervention. The study aims to improve sleep quality, decrease pain, reduce quality and decrease daytime sleepiness in elderly with OA.

NCT ID: NCT03353558 Not yet recruiting - Sleep Disorder Clinical Trials

Sleep Assessment in CML

CML-SLEEP
Start date: December 2017
Phase: N/A
Study type: Observational

Patients with CML report on fatigue, and many of them report on sleep disturbances. The investigators wish to objectively assess the patient's sleep using a sleep "wrist watch" (Actigraph) , and correlate data with their perception of sleep quality. A matched participants group will serve as control. the Control group is defined as participants not having CML or any other malignancy and without any known sleep disturbances.