NCT05972187

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

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

March 24, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 18, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2024

Completed
Last Updated

March 24, 2025

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

March 24, 2023

Last Update Submit

March 20, 2025

Conditions

Keywords

TemperatureHumidityThermoregulationCognitionHealth

Outcome Measures

Primary Outcomes (1)

  • Cognition

    Using a tablet based cognitive test battery

    1 month

Secondary Outcomes (5)

  • Heart Rate (bpm)

    1 month

  • Blood pressure (mmHg)

    1 month

  • Metabolic Rate (ml O2//min/kg)

    1 month

  • Skin Temperature (C)

    1 month

  • Body Core Temperature (C)

    1 month

Other Outcomes (2)

  • Room Temperature (C)

    1 month

  • Humidity (%)

    1 month

Study Arms (1)

Temperature and Humidity

EXPERIMENTAL

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

Other: Temperature and Humidity

Interventions

Temperature and Humidity of room changed

Temperature and Humidity

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Body Temperature ChangesDisease

Interventions

TemperatureHumidity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Guy Plasqui, PHD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2023

First Posted

August 2, 2023

Study Start

June 18, 2023

Primary Completion

May 7, 2024

Study Completion

May 7, 2024

Last Updated

March 24, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

If requested raw data will be provided.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Ongoing, depends on the request.
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.

Locations