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Sleepiness clinical trials

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NCT ID: NCT06371352 Not yet recruiting - Bipolar Disorder Clinical Trials

Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression

Start date: May 2024
Phase: N/A
Study type: Interventional

Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression.

NCT ID: NCT06336525 Not yet recruiting - Insomnia Clinical Trials

Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities.

Start date: May 1, 2024
Phase:
Study type: Observational

Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. There is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, as well as the disorders sleep apnea and insomnia, affect cardiometabolic disease risk. However, there is currently a lack of systematically developed sleep data in rural populations. The RURAL Sleep Study is an ancillary study to a recently initiated longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study). The RURAL Sleep Study will add measures of sleep health to the complex individual, social and environmental factors and health outcome measures being evaluated by the RURAL Study, by incorporating minimally burdensome measures of multiple dimensions of sleep health. The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health.

NCT ID: NCT06306092 Not yet recruiting - Depression Clinical Trials

Promoting Teenage Sleep for Improved Mental Health and School Performance

TeenSleep
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group).

NCT ID: NCT06027047 Not yet recruiting - Anxiety Disorders Clinical Trials

Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)

BASEL
Start date: September 1, 2023
Phase:
Study type: Observational

Sleep is not simply the absence of wakefulness. Sleep is an active procedure, normally happening every night, and is absolutely vital. Good sleep is essential for our well-being. Survival without food can be further than without sleep. Work time and commuting time seem to affect total sleep time and night bedtime. Social and work obligation can, therefore, suppress sleep time. Sleep deprived individuals may be facing anxiety and depression symptoms. The aim of this study is to investigate the presence of anxiety and depression symptoms among adults with the use of the smartphone application Onar. Onar app will be used to gather information from wearable devices of the users including total sleep time, sleep efficiency, wake after sleep onset time. An established questionnaire (Hospital Anxiety Depression Scale/ HADS) will be used to quantify and detect the presence of anxiety and depression in the study population.

NCT ID: NCT05116657 Not yet recruiting - SARS-CoV2 Infection Clinical Trials

Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome

Start date: November 22, 2021
Phase:
Study type: Observational

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) causing coronavirus disease, Covid-19, has spread rapidly across the globe since its emergence in January 2020. As of January 2021, there are 87.6 million confirmed cases worldwide, with 1.9milion deaths. In conjunction with this high disease incidence, there have also been reports of Covid-19 related sleep disordered breathing, with up 18% in a Chinese study and 57% in an Italian study of individuals with Covid-19 reporting sleep disturbance. Obstructive Sleep Apnea (OSA) is a common, chronic condition due to partial or complete upper airway collapse during sleep. OSA is more common in males & obese individuals, both of which are more adversely affected by SARS-CoV-2 infection. Furthermore, inflammation of the upper airway, or nasal passages leading to congestion could lead to a compromised upper airway during sleep and subsequently, obstructive sleep apnea. We believe that's SARS -CoV-2 infection, and subsequent Covid-19 will lead to an altered microbiome in the upper airway. This is turn will lead to worsening nasal inflammation and congestion, which could predispose individual with previous Covid-19 disease to OSA. Additionally, OSA is treated with Continuous Positive Airway Pressure (CPAP) a machine which delivers pressurized air into the upper airway via a face mask. This keeps the upper airway open during sleep. When CPAP is well tolerated by individuals, it works well to reduce the symptoms of OSA. Unfortunately, many patients find it difficult to tolerate CPAP. One reason often reported for poor tolerance is nasal congestion. We believe that an altered upper airway microbiome, due to previous SARS-CoV-2 infection, will affect treatment adherence to CPAP therapy. Secondly, we will investigate if treatment with CPAP therapy causes any change in the upper airway microbiome.

NCT ID: NCT05056194 Not yet recruiting - Parkinson Disease Clinical Trials

Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease Study

Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

Following screening visit and verification of inclusion/exclusion criteria and informed consent, participants will undergo a multiple sleep latency test (MSLT) and polysomnogram (PSG) assessments to confirm eligibility for randomization. Participants will be randomized to two groups: placebo or XW10172 MR. The drug will be taken orally at bedtime for 6 weeks of treatment that will consist of a 2-week dose escalation/titration period and a 4-week stable-dose maintenance period. There will be a 2-week safety period following dosing.

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: NCT03299257 Not yet recruiting - OSA Clinical Trials

Donepezil, Residual Excessive Daytime Sleepiness, Obstructive Sleep Apnea

Start date: July 6, 2018
Phase: Phase 4
Study type: Interventional

It is a randomized, double-blind, single-center, 30-day study. Patients aged 35-60 years, with apnea and hypopnea index and respiratory disturbance index normalized with CPAP, and Epworth Sleepiness Scale> 11. Patients undergo baseline and CPAP titration polysomnography, liquor and blood collection, Multiple Sleep Latency Test, anxiety and depression and cognitive assessments.