NCT06380582

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

April 25, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2025

Completed
Last Updated

March 24, 2025

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

April 18, 2024

Last Update Submit

March 20, 2025

Conditions

Keywords

Indoor air qualityTemperatureCognitionMetabolism

Outcome Measures

Primary Outcomes (2)

  • Cognition Morning

    Cambridge Neuropsychological Test Automated Battery (CANTAB) once at 11am and once at 230pm

    1 month

  • Cognition Afternoon

    Cognitive Ability Task - once at 4pm

    1 month

Secondary Outcomes (6)

  • Heart Rate (bpm)

    1 month

  • Metabolic Rate (ml/kg/min)

    1 month

  • Blood Pressure (mmHg)

    1 month

  • Blood samples

    1 month

  • Saliva samples

    1 month

  • +1 more secondary outcomes

Other Outcomes (3)

  • Temperature (C)

    1 month

  • Humidity %

    1 month

  • Carbon dioxide (CO2) concentration (ppm)

    1 month

Study Arms (2)

Air flow

EXPERIMENTAL

low airflow and high airflow

Other: Temperature and Airflow combination

Temperature

EXPERIMENTAL

23C 40%RH or 35C 40%RH

Other: Temperature and Airflow combination

Interventions

23C 40%Relative Humidity (RH) low airflow, 23C 40%RH high airflow, 35C 40%RH low airflow, 35C 40% high airflow

Air flowTemperature

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Interventions

Temperature

Intervention Hierarchy (Ancestors)

ThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment, ControlledEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 24, 2024

Study Start

April 25, 2024

Primary Completion

March 6, 2025

Study Completion

March 6, 2025

Last Updated

March 24, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Open Access upon request of fully anonymized data after initial analysis

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Open Access upon request of fully anonymized data after initial analysis

Locations