Skip to main content
OpenTrials
Completed

NCT Number: NCT03558698

Are Cognition and Sleep Affected by Exposure to Carbon Dioxide and Bio Effluents During Sleep?

The aim of the project is to examine whether children's sleep and cognition are affected by exposure to CO2 and other bio effluents during sleep. The participants of the study are 36 children recruited from local schools in Aarhus, Denmark.

The study takes place in the climate chambers at the Department of Public Health, Aarhus University. These chambers allow for experimental testing on humans with advanced exposure generation while avoiding contamination from other sources and controlling temperature, humidity, noise, odor, and light.

The children will be sleeping in the chambers under three different conditions:

* One night of good ventilation with a CO2 level of maximum 800 ppm * One night of good ventilation with high levels of CO2 (3,000 ppm) * One night of poor ventilation with high concentrations of CO2 (3000 ppm) and other bio effluents.

The study is a within-group design, and groups of six children will be sleeping in the chambers for three nights (separated by seven days). The different groups of children are exposed to the conditions in a randomized order. The study is double-blinded (of security reasons the persons responsible for CO2 concentrations in the chambers are not blinded).

The study takes place on schools nights. The children arrive at 6 pm and leave for school the morning after. In the evening the children are tested for approximately 30-40 minutes to measure their cognitive performance using CANTAB (Cambridge Neuropsychological Test Automated Battery) on iPads. After completing the test, dinner is served and the children have some spare time before going to bed. During night, the quality of sleep (awake time and different sleep stages) will be monitored using Fitbit devices. Sleep quality will also be evaluated using a short sleep questionnaire. The next morning the cognitive performance of the children will be tested again using CANTAB before the children leave for school.

Our primary hypothesis is that children will perform worse on the cognitive test when exposed to high levels of CO2 and other bio effluents than compared to low levels of CO2 and bio effluents in a well-ventilated room. In addition to that our secondary hypotheses are:

* Children will perform worse on the cognitive test when exposed to high levels of CO2 and other bio effluents than compared to CO2 alone. * Children will sleep less well in an environment with poor ventilation and high levels of CO2 and other bio effluents compared to sleeping in a well-ventilated room with low levels of CO2. * Children will sleep less well in an environment with poor ventilation and high levels of CO2 and other bio effluents compared to sleeping in a room with high levels of CO2 alone. * Children will sleep less well and perform worse on the cognitive test when exposed to high levels of CO2 compared to low levels of CO2.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University, Department of Public Health, Section for Environment, Occupation and Health

Aarhus, DK-8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children or children with a well-treated chronic disease not interfering with cognition and sleep quality
  • Being able to accomplish a CANTAB test
  • Completed questionnaires of sleep patterns

Exclusion criteria

  • Unable to spend three nights (separated by seven days) in the climate chambers
  • Conditions that prevent safe access to the chambers such as claustrophobia

Treatment and study plan

Good ventilation

Other

Good ventilation with a low concentration of CO2

Ventilation CO2

Other

CO2 High and Good ventilation

Poor Ventilation

Other

Poor ventilation with high concentrations of CO2 and bio effluents

Primary outcomes

  1. Reaction time (Simple)

    Time frame: 10 hours post start of exposure

    Reaction time in milliseconds. Outcome from CANTAB RTI Simple.

Secondary outcomes

  1. CANTAB global composite score

    Time frame: 10 hours post start of exposure

    CANTAB global composite score = outcomes from CANTAB transformed into a global composite score.

  2. Reaction Time (Five-Choice)

    Time frame: 10 hours post start of exposure

    Reaction time in milliseconds. Outcome from CANTAB RTI Five-Choice.

  3. Sleep efficiency

    Time frame: Sleep measured for 9 hours during exposure in bed from 9 pm to 6 am.

    Sleep efficiency = Percentage of time in bed spent sleeping.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Danish: Projekt God-Nat. Et Studie af søvnmiljøets Betydning for børns indlæringsevne English: Good Night: A Study of the Impact of the Sleep Environment on Learning in Children

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2018
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.