View clinical trials related to Alertness.
Filter by:The investigators goal is to target FUS energy to the centromedian nucleus of the thalamus (CMT), the core of arousal, which is inaccessible by traditional non-invasive neuromodulation devices. The CMT is an ideal stimulation target for augmenting alertness, as it is intimately linked with the cortex through the well described thalamocortical circuit to entrain network oscillations.
The purpose of this study is to determine whether personalized lifestyle coaching minimizes the negative impact of circadian disruption on performance and recovery in emergency medicine physician trainees during night shifts.
This study examines the effectiveness of a biodynamic lighting intervention on the sleep, cognitive functions, and alertness of adults working from home. The biodynamic intervention is an innovative lighting solution that intends to harness both visual and non-visual effects of lighting through delivering varying intensities and spectra during working hours according to a preset protocol.
The purpose of this study is to determine if brief sounds or tones presented within a restricted period of recovery sleep after a period of sleep deprivation will enhance restorative properties and improve performance during a subsequent period of wakefulness.
The lockdowns and restrictions associated with the COVID-19 have created a seismic shift in where work is done. Prior to the pandemic, approximately 20% of individuals were working from home while during the pandemic, more than 70% of individuals worked from home. While it is unlikely that such a large percent of the population will remain working from home, the vast support from workers for such work arrangements and the potential increase in productivity means that there will likely be a revision of the work place with more individuals working from a home office environment than have done so in the past. One unintended aspect of working from home is a reduction in light exposure, especially in the contrast between the daytime and evening. Offices converted from bedrooms, basements, and kitchens are often illuminated in the recommended 50-100 lux range, as opposed to the approximately 500 lux of most offices. While this light intensity is sufficient to work or read by, it may be insufficient to maintain adequate mental and physical health. In addition to light allowing us to consciously perceive the world around us, light can also induce a variety of changes in physiology that can impact our health, notably inducing shifts in the timing of circadian rhythms, suppressing the onset of melatonin production, and increasing alertness with subsequent changes to sleep latency and architecture. These changes in sleep and circadian rhythms have been associated with a variety of pathologies including increased risk of metabolic, psychiatric, cognitive, and cardiovascular disorders, in addition to overall longevity. Development of an adequate prophylactic countermeasure for the circadian desynchrony to which home office workers are exposed is a critical step in maintaining the health of these individuals. There are two main studies. The first study (Years 1-2) will be an in-laboratory determination of the threshold of light needed to minimize the negative impact of nocturnal light exposure. The second study (Years 3-4) will be a field study applying this threshold to determine if whether in situ use of this light intensity during the day improves health and safety among home office workers. Current CT.gov represents the second part of this study i.e. "Study 2: The impact of daytime light intensity in home workplaces on health and well-being of remote workers. In study 2, investigators will examine a series of participants (N=36), each of whom will participate in a five-week experiment. Each participant will have a screening visit at their home. The study will be conducted over five successive one-week periods with two cohorts of participants experiencing the same series of lighting interventions. All data collection will be performed during the working days (Monday - Friday) when participants are exposed to the lighting in their home offices.
This study is designed to compare self-reported mood states for encapsulated caffeine compared to dose-matched free caffeine, when consumed as a ready-to-drink beverage in healthy subjects. Additionally, this study will characterize the plasma caffeine pharmacokinetic profile for the encapsulated and free caffeine beverages. Two different caffeine levels, 160 and 250 mg will be included, which represent more common caffeine consumption from typical energy drinks. The primary outcomes are alertness ratings from the Caffeine Research visual analog scale (VAS) and PK parameters over 12 hours. Secondary outcomes are Caffeine Research VAS scores (beyond alertness), three other symptom VAS scores, and vital signs for safety.
The primary aim of this randomised, double-blind, placebo-controlled, cross-over study is to assess the short-term cognitive effects of two beverages containing 100 and 300 mg coffeeberry extract (obtained from the fruit of the coffee plant (Coffea arabica) compared to a placebo beverage. The trial will utilise the COMPASS cognitive assessment system and cognitive demand battery (CDB) and mood visual analogue scales (VAS) with assessments taking place at baseline, 60- and 120-minutes post treatment, on four separate testing days separated by 7 days. A treatment containing 75 mg caffeine will be used as a positive control to document participants' responsiveness to an established psychostimulant.
The primary purpose is to test the short-term effects of the acute consumption of two novel beverages made from coffeeberries, the fruit of the coffee plant (Coffea arabica) benchmarked against caffeine on several aspects of cognitive performance. Preliminary studies suggest that flavanols and chlorogenic acids can enhance cognitive performance. It is unknown if drinks formulated with flavanols and chlorogenic acids (without high sugar or caffeine) improve cognition or mood to a similar extent as caffeine. Coffeeberry beverage comparisons will be made to a flavored positive control beverage containing caffeine and a flavored placebo beverage.
The lockdowns and restrictions associated with the COVID-19 have created a seismic shift in where work is done. Prior to the pandemic, approximately 20% of individuals were working from home while during the pandemic, more than 70% of individuals worked from home. While it is unlikely that such a large percent of the population will remain working from home, the vast support from workers for such work arrangements and the potential increase in productivity means that there will likely be a revision of the work place with more individuals working from a home office environment than have done so in the past. One unintended aspect of working from home is a reduction in light exposure, especially in the contrast between the daytime and evening. Offices converted from bedrooms, basements, and kitchens are often illuminated in the recommended 50-100 lux range, as opposed to the approximately 500 lux of most offices. While this light intensity is sufficient to work or read by, it may be insufficient to maintain adequate mental and physical health. In addition to light allowing us to consciously perceive the world around us, light can also induce a variety of changes in physiology that can impact our health, notably inducing shifts in the timing of circadian rhythms, suppressing the onset of melatonin production, and increasing alertness with subsequent changes to sleep latency and architecture. These changes in sleep and circadian rhythms have been associated with a variety of pathologies including increased risk of metabolic, psychiatric, cognitive, and cardiovascular disorders, in addition to overall longevity. Development of an adequate prophylactic countermeasure for the circadian desynchrony to which home office workers are exposed is a critical step in maintaining the health of these individuals. There are two main studies. The first study (Years 1-2) will be an in-laboratory determination of the threshold of light needed to minimize the negative impact of nocturnal light exposure. The second study (Years 3-4) will be a field study applying this threshold to determine if whether in situ use of this light intensity during the day improves health and safety among home office workers. Current CT.gov represents the second part of this study i.e. "Study 2: The Impact of Daytime Light Intensity in Home Workplaces on Health and Well-being". In study 2, investigators will examine a series of participants (N=36), each of whom will participate in a five-week experiment. Each participant will have a screening visit at their home. The study will be conducted over five successive one-week periods with two cohorts of participants experiencing the same series of lighting interventions. All data collection will be performed during the working days (Monday - Friday) when participants are exposed to the lighting in their home offices.
The success of human expedition missions critically depend on the ability of the crew to be alert and maintain high levels of cognitive function while operating complex, technical equipment. Optimal human health, performance and safety during space flight requires sufficient sleep and synchrony between the circadian pacemaker—which regulates the timing of sleep, endocrine function, alertness and performance—and the timing of the imposed sleep-wake schedule. Crewmembers of the 105-day simulation study will be required to work one night shift every sixth night. This schedule will likely result in sleep loss and circadian misalignment, especially when lighting conditions are similar to those that crewmembers experience during spaceflight. External mission controllers will work 24-hour shifts, also resulting in both sleep loss and circadian misalignment. It has been well documented in laboratory and field studies that both working the night shift and working extended duration shifts result in decrement alertness, performance and mood. In addition to the negative effects that night shift work has on alertness, performance and mood, shift work causes significant short and long-term health problems. Shift workers, particularly night shift workers who invert their normal sleep/wake schedule, suffer for several reasons. First, their endogenous circadian rhythms and the imposed sleep/work schedule are typically out of phase. This is similar to the experience of jet lag. However, while environment cues (e.g., sunrise, sunset, the timing of meals and sleep) enable travelers to adapt quickly to a new time zone, crewmembers in the 105-day simulation will be unable to do so because they will only spend one night of every five working. When working the night shift, the timing of meals, work, and sleep will therefore be out of phase with the normal entrained phase of the circadian timing system. Ingestion of meals at an inappropriate circadian phase results in impaired metabolism, likely underlying the gastrointestinal and metabolic problems experienced by shift workers. Second, this circadian misalignment leads to a substantial loss of sleep efficiency during the (daytime) sleep period, independent of, and in addition to, environmental obstacles to sleep (e.g., noise, light, other crewmembers). Third, misalignment of circadian phase coupled with sleep loss will each result in deterioration of alertness and impairment of performance during the night. Since these adverse effects are particularly acute on the first night of work, the plan for crewmembers on the Mars 105 mission to work the midnight shift every sixth night will subject them repeatedly to the performance impairments associated with acute circadian misalignment and acute sleep deprivation. Lighting Countermeasure. Our group at the Harvard Medical School has successfully developed and tested effective photic countermeasures to alleviate circadian misalignment and improve alertness, performance and mood in night shift workers. The most effective countermeasure to circadian alignment is appropriately-timed and sufficiently intense light. Light also acutely improves alertness, performance and mood. Most recently it has been reported that short wavelength light has been shown to be most effective for both resetting circadian rhythms and acutely improving performance during night work via antecedent suppression of the soporific hormone melatonin. These photic countermeasures have been tested in individual subjects living in laboratory simulations (Countermeasures readiness level/Technology readiness level 7; Evaluation with human subjects in controlled laboratory simulating operational spaceflight environment). The next critical step is to evaluate our countermeasures in an operational simulation of space flight that includes study of the interaction among crew members in a high fidelity simulation (Countermeasures readiness level/Technology readiness level 8; Validation with human subjects in actual operational spaceflight to demonstrate efficacy and operational feasibility). Adequate sleep and circadian alignment are critical to maintaining the health and performance of expedition mission crewmembers. Testing of the developed lighting countermeasure in a high fidelity operational environment imitating the conditions of a future expedition mission (e.g., to Mars) is critical to ensure countermeasure readiness and to reduce the risk of human performance errors due to factors related to circadian disruption, sleep loss and fatigue. Development and testing of this photic countermeasure for mission controllers working 24-hour shifts will further ensure the success of the future long duration expedition missions.