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Consciousness, Level Altered clinical trials

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NCT ID: NCT06029205 Completed - Nursing Caries Clinical Trials

Mindfulness Training in Nurses and Its Effect on Work Stress

Start date: August 9, 2021
Phase: N/A
Study type: Interventional

The aim of the study, which was planned in the experimental design type, was to determine the effect of the mindfulness-based stress reduction training on nurses' job stress. The sample of the study consisted of 70 nurses (35 in the experimental group, 35 in the control group) working in a university hospital in Çanakkale. The mindfulness-based stress reduction training was carried out as a group, once a week, for 8 weeks in total.

NCT ID: NCT04653597 Completed - Poisoning Clinical Trials

Non-invasive Airway Management of Comatose Poisoned Emergency Patients

NICO
Start date: May 16, 2021
Phase: Phase 3
Study type: Interventional

A decreased level of consciousness is a common reason for presentation to the emergency department (ED) and is often the result of intoxication (up to 1% of all ED visits and 3% of ICU admission). In France, approximately 165 000 poisoned patients are managed each year. Originally developed in head injured patients, the Glasgow Coma Scale (GCS) is a validated reproducible score evaluating the level of consciousness: a GCS ≤ 8 is strongly associated with reduced gag reflex and increased incidence of aspiration pneumonia. Although recommended for patients with traumatic brain injury and coma, it remains unknown whether the benefit of an invasive management of airways with sedation, intubation and mechanical ventilation should be applied to other causes of coma in particular for acute poisoned patients. The investigator hypothesize that a conservative management with close monitoring without immediate endotracheal intubation of these patients is effective and associated with less in-hospital complications (truncated at 28 days) compared to routine practice management (in which the decision of immediate intubation is left to the discretion of the emergency physician).

NCT ID: NCT04366544 Completed - Depression Clinical Trials

Effects of an 8-day Advanced Meditation, Samyama on Physical, Psychological and Spiritual Wellbeing ,and Associated Neural Mechanisms

Start date: January 19, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of Samyama program on blood levels of selected neurotransmitters before and after the program, and associate with corresponding effects on mind/psyche before and after the program in adult participants. Hypothesis: 1. The state of higher consciousness and ecstasy resulting from Samyama result from increased levels of Anandamide, an endocannabinoid, and Brain Derived Neurotrophic Factor (BDNF). 2. The 60-day preparatory phase that includes dietary regulation and yogic practices will reduce the gut inflammation and thereby will improve the gut microbiome.

NCT ID: NCT03814356 Completed - Coma Clinical Trials

Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness

STIMPACT
Start date: August 24, 2020
Phase: Phase 1
Study type: Interventional

Phase 1 of the STIMPACT trial is an open label,dose-escalation,safety study of intravenous (IV) methylphenidate (MPH) therapy in patients with disorders of consciousness (DoC) caused by severe brain injuries. To be classified as having a DoC, a patient must be in a coma, vegetative state (VS), or minimally conscious state (MCS), as determined by behavioral assessment using the Coma Recovery Scale-Revised (CRS-R). Patients with DoC admitted to the intensive care unit (ICU) will be eligible for the study. A total of 10 patients with DoC will be enrolled in the Phase 1 study. Patients will receive escalating daily doses of IV MPH starting at 0.5 mg/kg, increasing stepwise to 1.0mg/kg and 2.0 mg/kg unless an adverse event (AE) necessitates dose de-escalation or a serious adverse event (SAE) necessitates that the patient stop participation in the study. Pharmacokinetics will be evaluated in selected patients with indwelling venous catheters or arterial catheters via serial serum measurements of MPH at each dose. The pharmacodynamic properties of IV MPH at each dose will be assessed by comparison of pre-versus post-dose EEG-based measures. The pharmacodynamic properties of the maximum tolerated dose will also be assessed by comparison of pre-versus post-dose resting state functional MRI (rs-fMRI) connectivity measures. Finally, we will test the association between structural connectivity of the ventral tegmental area (VTA), a dopaminergic brainstem nucleus that is believed to mediate MPH activation of the cerebral cortex, and EEG and rs-fMRI pharmacodynamic measures.

NCT ID: NCT03328221 Completed - Clinical trials for Acquired Brain Injury

Physical Activity on Heart Rate Variability in Patients With Severe Acquired Brain Injury

Start date: September 1, 2017
Phase:
Study type: Observational

This study aims to explore autonomic cardiovascular regulation, through measures of heart rate variability (HRV), during different passive and active activities in patients with severe acquired brain injury and a low conscious state. Data from active rehabilitation will be compared with passive periods of rest as well as nightly variance during a continuous 5-day period.

NCT ID: NCT01889004 Completed - Clinical trials for Consciousness, Level Altered

The Neural Mechanisms of Anesthesia and Human Consciousness

LOC-2013
Start date: February 2014
Phase: Phase 4
Study type: Interventional

The explanation of consciousness poses one of the greatest challenges to science and philosophy in the 21st century. It remains unclear what consciousness is and how it emerges from brain activity. By studying anesthesia and sleep, the investigators aim to reveal what happens in the brain when consciousness is lost and when it returns. During the study, a series of Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) studies will be carried out on healthy male subjects to reveal the neural correlates of consciousness. Consciousness of the subjects will be manipulated with normal sleep and anesthetic agents dexmedetomidine and propofol. First, various neurophysiological tools to separate consciousness, connectedness and responsiveness during normal sleep will be tested. The most suitable methods and subjects will be selected and then tested during anesthetic-induced sedation and loss of responsiveness (LOR). The anesthetics (dexmedetomidine or propofol) will be administered as target-controlled infusions (TCI) with step-wise concentration-increments until LOR is detected. Then, TCIs are repeated in the same subjects but adjusted according to the individual drug target concentrations sufficient for LOR, and a series of PET perfusion imaging measurements will be performed to obtain the brain activity information in various states of consciousness. The same subjects will then be imaged with PET for brain activity after sleep deprivation (awake), during various sleep stages and immediately after awakening. Finally, ten dexmedetomidine subjects will be given the drug once more, and functional MRI (fMRI) data will be collected at various states of consciousness before and during verbal and nonverbal vocalizations. EEG will be continuously collected in all sessions. The depth of anesthesia will be measured using quantitative EEG and bispectral index (BIS) monitoring. The results may lead to the discovery of new and better objective indicators of the depth of anesthesia and consciousness, and new insights into the understanding of neural mechanisms behind drug-induced loss of consciousness and ultimately the mechanisms of action of (general) anesthetics as well as consciousness itself.