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Stress Physiology clinical trials

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NCT ID: NCT06249685 Completed - Hearing Loss Clinical Trials

Does Wearing Hearing Aids Impact the Affective State of Older Adults With Hearing Loss in Their Daily Lives?

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

The proposed field trial will clarify the real-world effectiveness of HAs in remediating deficits in emotion processing for older adults with mild-to-moderate hearing loss. This study will employ a repeated reversal design to establish baseline affective state without HAs, when wearing amplification, and after HAs are removed. This study will triangulate self-report, behavioral, and physiological measures to capture nuances of emotional processing in the laboratory and in daily listening. Naturalistic stimuli will be used as it occurs in daily life to elicit emotional experiences, and ecological momentary assessment and commercially-available wearable sensors will be used to track changes in emotional state in daily listening. Anchoring real-world emotional experiences with controlled laboratory experiences will validate wearable sensors. Additionally, laboratory emotional stimuli will be related to real-world emotional experiences to establish the utility of laboratory stimuli in future studies. It is likely that benefits in emotional processing will have differential effects based on individual characteristics (such as degree of hearing loss, age, gender, cognitive ability, and personality), so participants will be analyzed according to larger groupings based on individual differences.

NCT ID: NCT05073406 Completed - Clinical trials for Cognitive Performance

Cognition at Altitude in HEMS - Part II

HEMS II
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The aim of the current study is to evaluate under blinded conditions, both in a simulated environment and during helicopter flight, the effect of a rapid (within 20 minutes) exposure to altitude (4000 m asl) on physiological parameters and selected cognitive domains, in providers operating in helicopter emergency medical service (HEMS) exposed to hypobaric hypoxia or to hypobaric normoxia (H0: cognitive effects under hypobaric hypoxia = cognitive effects under hypobaric normoxia). Simulated environment will allow to control different factors. The parallelism between a study branch conducted in a simulated environment and another one conducted under a real-life condition will allow to evaluate the additive effects on additional stressor factors (processive and systemic ones). - Simulation branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions in simulation facility called terraXcube (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the simulated altitude of 4000 m asl (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive tests three times on each of the two tests: before the ascent (TC0), after 5 min from the end of the ascent (TC1) and after around 30 min (TC2), to investigate European Union Aviation Safe Agency (EASA) proposed recommendations. After completing each neurocognitive test session, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests inside the chamber, as well as the cerebral oxygen saturation (ScO2) sensor. Samples will be collected by saliva, urine and/or capillary blood. The same schedule is repeated in each test session. - In-field branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions during helicopter flights (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the altitude of 4000 m (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive test two times on each test: before the ascent (TC0), after around 5 min from the end of the ascent (TC1). After completing each neurocognitive tests, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests. Samples will be collected. The same schedule is planned in each test session.

NCT ID: NCT04866901 Completed - Stress Clinical Trials

Interactive Effects of Mindfulness and Slow-paced Breathing

Start date: May 14, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to better understand specific stress-management practices on mood, sleep, and physiology. Participants will be assigned to one of three interventions (they all active interventions - none are a "wait-list"). Each intervention asks participants to engage in a daily practice of 20 minutes per day for 8 weeks. Questionnaires and measures of heart rate and blood pressure will be collected at the start and end of the 8 weeks, including a virtual laboratory visit.

NCT ID: NCT04138446 Completed - Resuscitation Clinical Trials

Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers

Start date: October 25, 2019
Phase: N/A
Study type: Interventional

The study aims to evaluate the effects of acute hypobaric hypoxia on cognitive performance (H0: cognitive performance at 200 meters above sea level (asl) = cognitive performance at 3000 meters above sea level = cognitive performance at 5000 meters above sea level). Before participating in the study, each participant will respond to a questionnaire related to high altitude exposure (prior 3 months), as well as inclusion/exclusion criteria evaluation. On day 0, after the interview and signed informed consent, the participant will undergo a medical examination that will include a general objective examination. Participants will participate in a training on the emergency and safety procedures of the hypobaric hypoxia facility, as well as a refresh on cardiopulmonary resuscitation procedure. During the following two days (day 1 and 2) the study protocol will be executed (one test per day). The study protocol envisages: - a basal cognitive test battery - blind ascent in the hypobaric chamber to simulated altitude - cognitive test battery - 5 minutes of recorded chest compressions on dummies - cognitive test battery - blind descent in the hypobaric chamber. During the stay in the hypobaric hypoxic facility, each participant will be monitored in real time with the Equivital© medical monitoring device. Before and after the stay in the hypobaric hypoxic facility, a saliva sample will be collected, and psychological tests administered.

NCT ID: NCT04127279 Completed - Clinical trials for Stress, Psychological

Stress Relief Properties of a Cosmetic Routine

Start date: January 15, 2018
Phase: Phase 4
Study type: Interventional

Everyday life psychosocial challenges may negatively impact health and well-being, contributing to the onset and/or progression of psychological and psychosomatic disorders. Pharmacological treatments can moderate our stress response, but they usually bring about addiction/tolerance and a number of other side effects. Therefore, it is relevant to identify alternative stress relief strategies that are devoid of these unwanted drawbacks. Moreover, the effects of such alternative interventions should be objectively quantified by means of reliable psychobiological parameters. The goal of this study was to quantify the acute and persistent effects of a cosmetic routine based on the self-administration of a cream enriched with essential oils, namely Juniperus Phoenicea gum extract, Copaifera Officinalis resin, Aniba Rosodora wood oil, and Juniperus Virginiana. This aim was achieved by measuring the (re-)activity of the autonomic nervous system (via heart variability indexes) and the hypothalamic-pituitary-adrenocortical axis (via salivary cortisol levels), as well as through psychometric and behavioral assessments. Participants' informed consent signature for adhesion at the study was initially requested. With their acceptance, parameters were recorded anonimously, identified by their initials and an alphanumeric code. Data were transferred on Excel worksheets, utilized for descriptive analysis related at every variable. All statistical analyses were performed using SPSS 25 software package and statistical significance was set at p<0.05.

NCT ID: NCT03203096 Completed - Stress Physiology Clinical Trials

Magnesium Supplementation in Stress Conditions

Start date: January 15, 2017
Phase: N/A
Study type: Interventional

This study aims to determine how a 6-week magnesium supplementation with 400 mg magnesium from magnesium citrate/magnesium oxide affects stress parameters in students in exam preparation.

NCT ID: NCT01009372 Completed - Stress Physiology Clinical Trials

The Intermittent Pneumoperitoneum Scheme of Work Breaks in Complex Laparoscopic Surgery

IPP
Start date: January 2007
Phase: N/A
Study type: Interventional

Many people spanning from air traffic controllers to simple production line workers share regular compulsive breaks to revert fatigue whilst they work. This is uncommon for medical operators - a macho image is still as prevalent in real life as it is in countless TV series. We report on the first clinical trial on regular intraoperative breaks. For one time we turned our scientific curiosity to ourselves. This included the intraoperative collection of body fluids and required transparency which was not easy to obtain. It was rewarded with striking results: Regular intraoperative breaks lowered significantly the operators stress hormone levels, improved error-performance testing results and musculoskeletal fatigue scores. Subjectively the breaks enhanced the practitioners satisfaction. Surprisingly the operator's breaks were not at the cost of the patient: because the did not prolong the overall operation time at all and - in our setting- they significantly increased of cardiac output and urine production.