Indoor Air Quality, Temperature and Cognitive Performance (AEOLUS)

March 20, 2025 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ER
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Air flow
low airflow and high airflow
Other: Temperature and Airflow combination
23C 40%Relative Humidity (RH) low airflow, 23C 40%RH high airflow, 35C 40%RH low airflow, 35C 40% high airflow
Experimental: Temperature
23C 40%RH or 35C 40%RH
Other: Temperature and Airflow combination
23C 40%Relative Humidity (RH) low airflow, 23C 40%RH high airflow, 35C 40%RH low airflow, 35C 40% high airflow

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognition Morning
Time Frame: 1 month
Cambridge Neuropsychological Test Automated Battery (CANTAB) once at 11am and once at 230pm
1 month
Cognition Afternoon
Time Frame: 1 month
Cognitive Ability Task - once at 4pm
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart Rate (bpm)
Time Frame: 1 month
Using a wearable heart rate belt for beat by beat
1 month
Metabolic Rate (ml/kg/min)
Time Frame: 1 month
Omnical system with a minute frequency
1 month
Blood Pressure (mmHg)
Time Frame: 1 month
Using an automate blood pressure cuff every hour
1 month
Blood samples
Time Frame: 1 month
Blood drawn for future analysis 4 times every 2 hours
1 month
Saliva samples
Time Frame: 1 month
Saliva collected for future analysis 4 times every 2 hours
1 month
Breathing rate
Time Frame: 1 month
Spirometer used 4 times every 2 hours
1 month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Temperature (C)
Time Frame: 1 month
Room temperature using an environmental sensor
1 month
Humidity %
Time Frame: 1 month
Relative Humidity using an environmental sensor
1 month
Carbon dioxide (CO2) concentration (ppm)
Time Frame: 1 month
Carbon dioxide using an environmental sensor
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL85595.068.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Open Access upon request of fully anonymized data after initial analysis

IPD Sharing Time Frame

Open Access upon request of fully anonymized data after initial analysis

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings