Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06380582 |
| Other study ID # |
NL85595.068.23 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 25, 2024 |
| Est. completion date |
December 21, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Maastricht University Medical Center |
| Contact |
Cynthia Ly |
| Phone |
+31433884259 |
| Email |
c.ly[@]maastrichtuniversity.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Study design: A cross-over single-blinded treatment design will be used. Participants will
undergo 4 different conditions: (1) low air flow and 23°C, (2) low air flow and 35°C, (3)
high air flow and 23°C, and (4) high air flow and 35°C. Participants will be blinded to the
air quality level; however, it is not possible to blind them to the temperature condition, as
they will be able to perceive it as different.
Study population: The population consists of healthy young and middle-aged adults of both
sexes between 18 and 40 years.
Intervention (if applicable): Each participant undergoes 4 conditions in randomized order.
Two conditions consist of poor air quality defined as 3,000 ppm carbon dioxide and 23°C or
35°C temperature, respectively.
Description:
Objective: This study aims to examine the effect of indoor air quality and temperature on
human cognitive performance. The main research objective of this study is to examine how
indoor air quality and temperature affects cognitive performance, respectively. As a
secondary objective, it will be examined if a higher temperature of 35°C compared to 23°C
amplifies the negative effect of low air flow vs. high air flow on cognitive performance. It
will also be examined if human perceive the air quality as less pleasant under the higher
temperature, even if the air quality itself does not change in terms of carbon dioxide
concentration. Also, the physiological reaction towards poor air quality and elevated
temperature will be examined in isolation and interaction.
Main study parameters/endpoints: The main study parameters are the achieved scores of the
cognition test, mainly derived from the Cambridge Neuropsychological Test Automated Battery
(CANTAB) and the Cognitive Ability Task. As secondary outcome, the physiological response
will be examined. Specifically, it will be investigated how the air quality and temperature
affect the following physiological parameters: Capillary blood CO2 and pH level, salivary
cortisol and a-amylase and serum cytokine response, lung function, heart rate, respiration
rate, skin temperature, core temperature, blood pressure, physical activity, and metabolic
rate.
Primary Objective: The main research objective of this study is to examine how poor indoor
air quality in terms of low air flow compared to high air flow and elevated temperature of
35°C compared to 23°C affect cognitive performance, respectively.
Secondary Objective(s): The following secondary objectives will be investigated in this
study:
1. It will be examined whether the decline in cognitive performance is greater when low air
quality to high air quality compared to when temperature levels are increasing from 23°C
to 35°C.
2. It will be examined whether a higher temperature of 35°C compared to 23°C amplifies the
negative effect of poor air quality.
3. It will be examined whether participants perceive the air quality as less satisfactory
if temperature levels are higher indoors, even when the air quality is unchanged. It
will be also examined to which physiological reactions poor air quality and elevated
temperature lead. Specifically, the following objectives will be investigated:
4. It will be examined whether metabolic rate is affected under poor air quality conditions
or higher temperature indicated by a change in CO2 production and oxygen consumption.
5. It will be examined whether poor air quality or higher temperature levels are associated
with a stress response defined by a higher heart rate, higher respiration rate, higher
blood pressure, higher alpha-amylase and cortisol levels, and a higher rate of
non-exercise activity thermogenesis through increased physical activity.
6. It will be examined whether lung function in terms of forced expiratory volume and
forced vital capacity are reduced when participants are exposed to poor air quality in
combination with a higher temperature of 35°C.
7. It will be examined whether blood capillary carbon dioxide concentration and blood pH
level are elevated under worse air quality in combination with a higher temperature of
35°C.
