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Clinical Trials/NCT04160741
NCT04160741CompletedNot Applicable

Effects of Solar Radiation on Human Function and Cognition

Petros Dinas1 site in 1 country7 target enrollmentStarted: February 15, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
7
Locations
1
Primary Endpoint
Thermal sensation

Study Overview

Brief Summary

Solar radiation is a physical phenomenon which interacts with any human being throughout its life on earth. This interaction is associated with numerous physiological functions, as well as a broad spectrum of deleterious effects on human health and wellbeing. The aim of this study is to elucidate the effects of solar radiation on human function and cognition in environmental conditions characterized by the same thermal stress.

Detailed Description

Volunteers were exposed to four different environmental conditions [two hot environments: 30°C WBGT (1st: air temperature = 32.6°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 800 W/m2 and 2nd. air temperature = 40.6°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 0 W/m2) and two neutral environments: 20°C WBGT (1st: air temperature = 19.1°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 800 W/m2 and 2nd. air temperature = 28.5°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 0 W/m2], over an equal number of days. The aforementioned environmental scenarios were randomly allocated for each volunteer. To minimize participant bias, the true purpose of the study was hidden from the volunteers. Of course, once the data collection was completed, all volunteers were informed about the true purpose of the study and gave their permission to analyze and publish these data. During this blinded randomized controlled trial, all volunteers participated four times in an experimental protocol with a total duration of 03:20:00, following an hour of preparation and baseline tests. The protocol had three main time periods [rest (two hours), work (cycling) at 100 W (one hour), and recovery (twenty minutes)]. Anthropometrical data [age; body stature (Seca 213; seca GmbH & Co. KG; Hamburg, Germany); body mass (BC1000, Tanita corporation, Tokyo, Japan); body fat (DXA scan: Lunar DPX Madison, GE Healthcare, Wisconsin, USA); and lean mass (DXA scan: Lunar DPX Madison, GE Healthcare, Wisconsin, USA)] were collected two days prior to the experiments.

Volunteers were euhydrated prior to the experiments. Hydration status was assessed using a handheld refractometer (ATAGO Ltd, Tokyo, Japan) and determined as either euhydrated (USG < 1.020) or dehydrated (USG ≥ 1.020) according to the current guidelines. Water consumption was restricted during the experimental protocol. The same clothing consisting of a light-blue t-shirt (100% cotton), a black exercise short pant (100% polyester), and a pair of medium-high socks (100% cotton) were used by volunteers throughout the experiments. A pair of sunglasses was mandatory to be worn throughout the experiments. Furthermore, experiments took place during the same hour of the day for each participant and an 8-hour fasting was ensured prior to the experiments. Furthermore, participants were requested to avoid caffeine and alcohol consumption for at least twelve hours before the experiments, as well as to avoid salt and sugar consumption eight hours before the experiments.

During the study, continuous heart rate, core temperature, mean skin temperature, skin blood flow, and sweat rate were measured. Specifically, heart rate was collected using wireless heart rate monitors (Polar Team2. Polar Electro Oy, Kempele, Finland). Core temperature was collected using telemetric capsules (BodyCap, Caen, France). Skin temperature from four sites was measured using wireless thermistors (iButtons type DS1921H, Maxim/Dallas Semiconductor Corp., USA) and was expressed as mean skin temperature according to Ramanathan [mean skin temperature = 0.3(chest + arm) + 0.2(thigh + leg). Skin blood flow was measured with a laser Doppler flowmeter (PeriFlux 4000, Perimed, Stockholm, Sweden) at right forearm (brachioradialis) and leg (gastrocnemius). The probe (PROBE 413 Integrating Probe, Perimed, Stockhold, Sweden) was held in place with a plastic holder (PH 13, Perimed, Stockhold, Sweden). Sweat rate was measured at three regions [forehead, thigh (quadricep), and arm (bicep)] using ventilated capsule method. Thermal comfort (1 = comfortable; 5 = extremely uncomfortable), thermal sensation (-3 = cold; +3 = hot), and perceived exertion (6 = no exertion at all; 20 = maximal exertion), alongside cognitive performance (vigilance, divided attention, memory test, and reaction time) were assessed at baseline, pre work condition (01:40:00), and post work (03:00:00) conditions. Volunteers entered the chamber five minutes prior to the experiments to install data loggers and accompanied sensors on their body.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy non-smoker individuals who exercise at least three times per week

Exclusion Criteria

  • •Non healthy individuals and smokers

Arms & Interventions

Hot environment with radiation

Experimental

Exposure to hot environment (30°C WBGT) with radiation (800 W/m2)

Exposure for 03:20:00:

  • rest (two hours)
  • work (cycling) at 100 W (one hour)
  • recovery (twenty minutes)

Intervention: Radiation and warm environment (Other)

Hot environment without radiation

Experimental

Exposure to hot environment (30°C WBGT) with radiation (0 W/m2)

Exposure for 03:20:00:

  • rest (two hours)
  • work (cycling) at 100 W (one hour)
  • recovery (twenty minutes)

Intervention: Warm environment (Other)

Neutral environment with radiation

Experimental

Exposure to neutral environment (20°C WBGT) with radiation (800 W/m2)

Exposure for 03:20:00:

  • rest (two hours)
  • work (cycling) at 100 W (one hour)
  • recovery (twenty minutes)

Intervention: Neutral environment with radiation (Radiation)

Neutral environment without radiation

Active Comparator

Exposure to neutral environment (20°C WBGT) with radiation (0 W/m2)

Exposure for 03:20:00:

  • rest (two hours)
  • work (cycling) at 100 W (one hour)
  • recovery (twenty minutes)

Intervention: Neutral environment without radiation (Other)

Outcomes

Primary Outcomes

Thermal sensation

Time Frame: Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".

Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)

Core body temperature

Time Frame: 03 hours and 20 minutes

Core body temperature was assessed throughout the entire protocol using telemetric capsules (e-Celsius, BodyCap, Caen, France) that was given to the workers to ingest prior to their work shift

Cognitive performance (Memory Test)

Time Frame: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".

This is a computerized version of Sternberg's memory task. In this task volunteers had to observe carefully a random sequence of one to six digits (0 to 9) painted in white and displayed for 1.2 seconds each. Thereafter, a two second delay was followed by a random test digit filled in yellow color. Participants had to response as fast as possible by pressing "yes" or "no" button to indicate where the yellow digit appeared in the previous sequence or not, respectively. In this test participants were tested in 24 trials.

Thermal comfort

Time Frame: Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".

Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).

Heart rate

Time Frame: 03 hours and 20 minutes

Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland

Mean skin temperature

Time Frame: 03 hours and 20 minutes

Temperature at the skin surface area was continuously monitored using iButton sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA)

Skin blood flow

Time Frame: 03 hours and 20 minutes

Skin blood flow was measured throughout the entire protocol with a laser Doppler flowmeter (PeriFlux 4000, Perimed, Stockholm, Sweden) at right forearm (brachioradialis) and leg (gastrocnemius)

Sweat rate

Time Frame: 03 hours and 20 minutes

Sweat rate was measured throughout the entire protocol at three regions \[forehead, thigh (quadricep), and arm (bicep)\] using ventilated capsule method

Perceived exertion

Time Frame: Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".

We used the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)

Cognitive performance (Vigilance)

Time Frame: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".

Vigilance was assessed via vigilance test. In this task two squares arranged vertically. A pattern jumps from one square to the other. Sometimes the pattern remains in one square. In this case volunteers had to touch the screen of a tablet computer as fast as possible. The total duration for the current task was set to 6 minutes. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.

Cognitive performance (Divided Attention)

Time Frame: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".

Divided attention task incorporates both auditory and visual stimuli in parallel. During the test a number of visual stimuli (crosses) appear in a random configuration in a 4X4 matrix. At the same time volunteers hear high and low beeps in a random order. The task is to detect whether crosses form a square and at the same time two high or low beeps are emitted twice in a row. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.

Cognitive performance (Reaction Time)

Time Frame: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".

In this task participants had to respond as quickly as possible, by untouching the screen, after receiving a visual or acoustic stimulus.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Petros Dinas
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Petros Dinas

Senior Researcher in human physiology

University of Thessaly

Study Sites (1)

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