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The Effect of IEQ on Cognition and Health (IEQ-HUM)

Primary Purpose

Environmental Exposure, Temperature Change, Body, Condition

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Temperature and Humidity
Sponsored by
Maastricht University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Environmental Exposure focused on measuring Temperature, Humidity, Thermoregulation, Cognition, Health

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: BMI between 18.5-26 kg/m2 Age between 20-40 years Proficient with the English language in both verbal and written form Healthy; no illness or disease or prescribed medication within the last 3 months Steady dietary and sleeping habits Regularly physically active (i.e., regularly active but less than 3 times a week for less than 2 hours per session at moderate intensity) Non-smoker or person who quit smoking more than five years ago Reside in the Netherlands (or surrounding countries) for at least 6 months Exclusion Criteria: Subjects with cardiac problems and cardiovascular diseases, such as angina pectoris, cardiac infarction, and arrhythmias Subjects with any medical condition requiring treatment and/or medication (except oral contraceptives) that might interfere with the investigated parameters E.g., Extreme chronotype, colour blindness, epilepsy Subjects with a disorder or disease (Parkinson, Attention Deficit Hyperactivity Disorder (ADHD), Alzheimer, diabetes, cardiovascular disorder, respiratory impairments (for example asthma), hypertension, obesity, or any other condition that can impair the lung function), or Raynaud's phenomenon Subjects with abnormal diet and sleeping patters and/or abnormal body weight (weight gain or loss >3kg in the past month) Subjects who recently participated in other interventional biomedical study within 1 month prior to screening visit Subjects, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician will be informed, cannot participate in this study Subjects with previous covid infection in the past 3 months or any subject with persistent long covid symptoms that may have caused ongoing loss of or altered sense of smell Subjects who had severely altered sleep patterns in the past year Subjects employed with night shift work within the past year Subjects who consume more than two standard drinks of alcohol per day Subjects who consume more than two standard drinks of coffee per day Subjects who are pregnant

Sites / Locations

  • Maastricht UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temperature and Humidity

Arm Description

32C or 25C and 30%RH or 70%RH

Outcomes

Primary Outcome Measures

Cognition
Using a tablet based cognitive test battery

Secondary Outcome Measures

Heart Rate (bpm)
Heart Rate measured using Polar heart rate belt in (bpm) with RR and ECG data extracted
Blood pressure (mmHg)
Blood pressure - both systolic and diastolic pressures measured hourly using an automated blood pressure monitor and cuff
Metabolic Rate (ml O2//min/kg)
Metabolic rates measured through whole room calorimetry
Skin Temperature (C)
Skin temperature measured using thermochron (ibuttons) at multiple sites
Body Core Temperature (C)
Core Temperature measured via telemetric pill ingested in the morning

Full Information

First Posted
March 24, 2023
Last Updated
September 14, 2023
Sponsor
Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT05972187
Brief Title
The Effect of IEQ on Cognition and Health
Acronym
IEQ-HUM
Official Title
The Effect of the Indoor Environmental Quality (IEQ) on Cognition and Health
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this study is to learn about the effect of heat and humidity on cognition and health. The main question[s] it aims to answer are: type of study: interventional participant population: 20-40years, both gender, healthy Participants will be exposed for 4 different sessions of 8 hours at a time, to 32˚ C or 25˚ C in combination with relative humidity of 30 %RH or 70 %RH.
Detailed Description
Overall, the project aims to evaluate the effects of high vs. neutral temperature (32˚ C vs. 25˚ C) in combination with high vs. low humidity (30 %RH vs. 70 %RH) on cognition, for longer exposure duration (8 hours). Deviations from the personal comfort zones are expected to affect both subjective feelings and physiological parameters. Therefore, the following parameters will be included: cognition, environmental perception, energy expenditure, body temperatures. Main research question and primary objective: What is the impact of being exposed for 8 hours to a high humidity (RH 70%) versus low humidity (RH 30%) on cognitive performance of individuals if the room temperature is 25ºC or 32ºC? This leads to the following hypotheses: Exposure to an indoor high relative humidity (RH 70%) at a warm temperature (32ºC) of a long duration (8 hours) reduces the composite score, speed and accuracy of cognitive performance compared to an exposure to a low RH (30%) at the same temperature (32ºC) due to the humidity. An exposure to an indoor high relative humidity (RH 70%) at a neutral temperature (25ºC) of a long duration (8 hours) would reduce the composite score, speed and accuracy of cognitive performance compared to an exposure to a low RH (30%) at a neutral temperature (25 ºC) due to previous literature for humidity influences at neutral temperatures. Secondary research question and secondary objective: What is the effect of high vs. neutral temperature (32˚ C vs. 25˚ C) in combination with high vs. low humidity (30 %RH vs. 70 %RH) on physiological responses, environmental perception, decision making, and bias behaviour? This leads to the following hypotheses: Does an 8 hour exposure to an elevated concentration of indoor humidity lead to an increase in energy expenditure and/or a greater difference in proximal and distal blood flow and skin temperature gradients compared to a lower indoor humidity for each of the temperature settings? What are the effects of high humidity on substrate oxidation, blood pressure, heart rate variability, proximal and distal skin temperature, risk behavior and decision-making responses of individuals? What are the effects of higher humidity on environmental perception (thermal, air quality, moisture/wetness) comfort, perception, and sensation? An exposure to an indoor high relative humidity (RH 70%) at a warm temperature (32ºC) of a long duration (8 hours) reduces the composite score, speed and accuracy of cognitive performance compared to an exposure to a high RH (70%) at a neutral temperature (25 ºC) due to the humidity and temperature. An exposure to an indoor low relative humidity (RH 30%) at a warm temperature (32ºC) of a long duration (8 hours) would reduce the composite score, speed and accuracy of cognitive performance compared to an exposure to the same low RH (30%) at a neutral temperature (25 ºC) due to the temperature. Exploratory research question and objective: What is the interaction effect of high vs. neutral temperature (32˚ C vs. 25˚ C) in combination with high vs. low humidity (30 %RH vs. 70 %RH) on cognitive performance, physiological responses, environmental perception, decision making, and bias behaviour?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Environmental Exposure, Temperature Change, Body, Condition, Healthy
Keywords
Temperature, Humidity, Thermoregulation, Cognition, Health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Temperature and Humidity
Arm Type
Experimental
Arm Description
32C or 25C and 30%RH or 70%RH
Intervention Type
Other
Intervention Name(s)
Temperature and Humidity
Intervention Description
Temperature and Humidity of room changed
Primary Outcome Measure Information:
Title
Cognition
Description
Using a tablet based cognitive test battery
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Heart Rate (bpm)
Description
Heart Rate measured using Polar heart rate belt in (bpm) with RR and ECG data extracted
Time Frame
1 month
Title
Blood pressure (mmHg)
Description
Blood pressure - both systolic and diastolic pressures measured hourly using an automated blood pressure monitor and cuff
Time Frame
1 month
Title
Metabolic Rate (ml O2//min/kg)
Description
Metabolic rates measured through whole room calorimetry
Time Frame
1 month
Title
Skin Temperature (C)
Description
Skin temperature measured using thermochron (ibuttons) at multiple sites
Time Frame
1 month
Title
Body Core Temperature (C)
Description
Core Temperature measured via telemetric pill ingested in the morning
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Room Temperature (C)
Description
Environmental measures are measured continuously using temperature specific sensors in the room
Time Frame
1 month
Title
Humidity (%)
Description
Environmental measures are measured continuously using humidity specific sensors in the room
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI between 18.5-26 kg/m2 Age between 20-40 years Proficient with the English language in both verbal and written form Healthy; no illness or disease or prescribed medication within the last 3 months Steady dietary and sleeping habits Regularly physically active (i.e., regularly active but less than 3 times a week for less than 2 hours per session at moderate intensity) Non-smoker or person who quit smoking more than five years ago Reside in the Netherlands (or surrounding countries) for at least 6 months Exclusion Criteria: Subjects with cardiac problems and cardiovascular diseases, such as angina pectoris, cardiac infarction, and arrhythmias Subjects with any medical condition requiring treatment and/or medication (except oral contraceptives) that might interfere with the investigated parameters E.g., Extreme chronotype, colour blindness, epilepsy Subjects with a disorder or disease (Parkinson, Attention Deficit Hyperactivity Disorder (ADHD), Alzheimer, diabetes, cardiovascular disorder, respiratory impairments (for example asthma), hypertension, obesity, or any other condition that can impair the lung function), or Raynaud's phenomenon Subjects with abnormal diet and sleeping patters and/or abnormal body weight (weight gain or loss >3kg in the past month) Subjects who recently participated in other interventional biomedical study within 1 month prior to screening visit Subjects, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician will be informed, cannot participate in this study Subjects with previous covid infection in the past 3 months or any subject with persistent long covid symptoms that may have caused ongoing loss of or altered sense of smell Subjects who had severely altered sleep patterns in the past year Subjects employed with night shift work within the past year Subjects who consume more than two standard drinks of alcohol per day Subjects who consume more than two standard drinks of coffee per day Subjects who are pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Ly, MSc
Phone
+31644602337
Email
C.ly@maastrichtunicersity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Plasqui, PHD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Ly
Phone
+31644602337
Email
C.ly@maastrichtuniversity.no

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
If requested raw data will be provided.
IPD Sharing Time Frame
Ongoing, depends on the request.
IPD Sharing Access Criteria
Official request made stating the purpose of use for the data. Only individuals that consent to their data to be used in further analysis will be shared.

Learn more about this trial

The Effect of IEQ on Cognition and Health

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