Indoor Air QualityAEOLUSNCT06380582
Indoor Air Quality, Temperature and Cognitive Performance
A study testing Temperature and Airflow combination in people with Indoor Air Quality and Temperature, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Indoor Air Quality, Temperature, Cognitive Performance
- What is being tested?
- Temperature and Airflow combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Apr 2024to 6 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between 18 to 40 years old
- Western-European background
- Generally healthy
- No medication which may influence the outcome parameters. This will be determined on a case-by-case basis. Contraceptive uses for women are allowed and will be verified through a questionnaire.
- Non-smokers or persons who quit smoking more than five years ago
Who cannot join
- Participants, 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
- Individuals with a diagnosed physical or mental disability or attention deficit hyperactivity disorder (ADHD) or depression
- Any medication or medical condition that might interfere with the physiological outcome parameters or in some regards impair cognition
- Unstable body weight (weight gain or loss >3kg in the past three months)
- Participation in another biomedical study within 1 month prior to screening visit
- Shift workers
Show all 11Show fewer
- Colour blindness
- Pregnancy
- People with a low haemoglobin or haematocrit concentration
- Not having visited or resided in a warm country in the last 3 months
- Participants with asthma or restricted lung function due to allergies
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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:
- 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.
- It will be examined whether a higher temperature of 35°C compared to 23°C amplifies the negative effect of poor air quality.
- 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:
- 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.
- 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.
- 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.
- 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.
- Conditions
- Indoor Air Quality, Temperature, Cognitive Performance
- Being tested
- Temperature and Airflow combination
- Keywords
- Indoor air quality, Temperature, Cognition, Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature and Airflow combinationOther
23C 40%Relative Humidity (RH) low airflow, 23C 40%RH high airflow, 35C 40%RH low airflow, 35C 40% high airflow
| Study group | Role | What they receive |
|---|---|---|
| Air flow | Experimental | low airflow and high airflow Receives: Other: Temperature and Airflow combination |
| Temperature | Experimental | 23C 40%RH or 35C 40%RH Receives: Other: Temperature and Airflow combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition Morning
Cambridge Neuropsychological Test Automated Battery (CANTAB) once at 11am and once at 230pm
Measured: 1 month
Cognition Afternoon
Cognitive Ability Task - once at 4pm
Measured: 1 month
Secondary outcomes (6)
Heart Rate (bpm)
Using a wearable heart rate belt for beat by beat
Measured: 1 month
Metabolic Rate (ml/kg/min)
Omnical system with a minute frequency
Measured: 1 month
Blood Pressure (mmHg)
Using an automate blood pressure cuff every hour
Measured: 1 month
Blood samples
Blood drawn for future analysis 4 times every 2 hours
Measured: 1 month
Saliva samples
Saliva collected for future analysis 4 times every 2 hours
Measured: 1 month
Breathing rate
Spirometer used 4 times every 2 hours
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start25 Apr 2024
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indoor Air QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380582
- Sponsor's protocol ID
- NL85595.068.23
- Acronym
- AEOLUS
- Status last verified
- Jun 2024
- First submitted
- 18 Apr 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Open Access upon request of fully anonymized data after initial analysis
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indoor Air Quality, Temperature and Cognitive Performance
- ClinicalTrials.gov ID
- NCT06380582
- Acronym / sponsor ID
- AEOLUS / NL85595.068.23
- Conditions
- Indoor Air Quality, Temperature, Cognitive Performance
- Keywords
- Indoor air quality, Temperature, Cognition, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- It will be examined whether a higher temperature of 35°C compared to 23°C amplifies the negative effect of poor air quality.
- 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:
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air flow | Experimental | Other: Temperature and Airflow combinationlow airflow and high airflow |
| Temperature | Experimental | Other: Temperature and Airflow combination23C 40%RH or 35C 40%RH |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults between 18 to 40 years old
- Western-European background
- Generally healthy
- No medication which may influence the outcome parameters. This will be determined on a case-by-case basis. Contraceptive uses for women are allowed and will be verified through a questionnaire.
- Non-smokers or persons who quit smoking more than five years ago
Key exclusion criteria (11 listed)
- Participants, 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
- Individuals with a diagnosed physical or mental disability or attention deficit hyperactivity disorder (ADHD) or depression
- Any medication or medical condition that might interfere with the physiological outcome parameters or in some regards impair cognition
- Unstable body weight (weight gain or loss >3kg in the past three months)
- Participation in another biomedical study within 1 month prior to screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temperature and Airflow combination23C 40%Relative Humidity (RH) low airflow, 23C 40%RH high airflow, 35C 40%RH low airflow, 35C 40% high airflow | Other | Air flow, Temperature |
Primary outcome
Cognition Morning
Time frame: 1 month
Cambridge Neuropsychological Test Automated Battery (CANTAB) once at 11am and once at 230pm
Cognition Afternoon
Time frame: 1 month
Cognitive Ability Task - once at 4pm
6 secondary outcomes
Heart Rate (bpm)
Time frame: 1 month
Metabolic Rate (ml/kg/min)
Time frame: 1 month
Blood Pressure (mmHg)
Time frame: 1 month
Blood samples
Time frame: 1 month
Saliva samples
Time frame: 1 month
Breathing rate
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Yes. Open Access upon request of fully anonymized data after initial analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temperature and Airflow combination in people with Indoor Air Quality and Temperature, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition Morning (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.