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

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT03558698
Collaborator
(none)
36
1
6
4.9
7.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Good ventilation
  • Other: Ventilation CO2
  • Other: Poor Ventilation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
The 36 children are divided into 6 groups of 6 children. Every group is exposed to all possible conditions (3) in a randomized order.The 36 children are divided into 6 groups of 6 children. Every group is exposed to all possible conditions (3) in a randomized order.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The study is double-blinded but a few people in the research team are not blinded because of security reasons (they need to be able to control the concentrations of CO2).
Primary Purpose:
Prevention
Official 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
Actual Study Start Date :
Jan 23, 2018
Actual Primary Completion Date :
Jun 22, 2018
Actual Study Completion Date :
Jun 22, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Group 1

One night of good ventilation with a CO2 level of maximum 800 ppm One night of good ventilation with high levels of CO2 (3000 ppm) One night of poor ventilation with high concentrations of CO2 (3000 ppm) and other bio effluents (The order of the three conditions are randomized)

Other: Good ventilation
Good ventilation with a low concentration of CO2

Other: Ventilation CO2
CO2 High and Good ventilation

Other: Poor Ventilation
Poor ventilation with high concentrations of CO2 and bio effluents

Other: Group 2

One night of good ventilation with a CO2 level of maximum 800 ppm One night of good ventilation with high levels of CO2 (3000 ppm) One night of poor ventilation with high concentrations of CO2 (3000 ppm) and other bio effluents (The order of the three conditions are randomized)

Other: Good ventilation
Good ventilation with a low concentration of CO2

Other: Ventilation CO2
CO2 High and Good ventilation

Other: Poor Ventilation
Poor ventilation with high concentrations of CO2 and bio effluents

Other: Group 3

One night of good ventilation with High CO2 level of maximum 800 ppm One night of good ventilation with high levels of CO2 (3000 ppm) One night of poor ventilation with high concentrations of CO2 (3000 ppm) and other bio effluents (The order of the three conditions are randomized)

Other: Good ventilation
Good ventilation with a low concentration of CO2

Other: Ventilation CO2
CO2 High and Good ventilation

Other: Poor Ventilation
Poor ventilation with high concentrations of CO2 and bio effluents

Other: Group 4

One night of good ventilation with a CO2 level of maximum 800 ppm One night of good ventilation with high levels of CO2 (3000 ppm) One night of poor ventilation with high concentrations of CO2 (3000 ppm) and other bio effluents (The order of the three conditions are randomized)

Other: Good ventilation
Good ventilation with a low concentration of CO2

Other: Ventilation CO2
CO2 High and Good ventilation

Other: Poor Ventilation
Poor ventilation with high concentrations of CO2 and bio effluents

Other: Group 5

One night of good ventilation with a CO2 level of maximum 800 ppm One night of good ventilation with high levels of CO2 (3000 ppm) One night of poor ventilation with high concentrations of CO2 (3000 ppm) and other bio effluents (The order of the three conditions are randomized)

Other: Good ventilation
Good ventilation with a low concentration of CO2

Other: Ventilation CO2
CO2 High and Good ventilation

Other: Poor Ventilation
Poor ventilation with high concentrations of CO2 and bio effluents

Other: Group 6

One night of good ventilation with a CO2 level of maximum 800 ppm One night of good ventilation with high levels of CO2 (3000 ppm) One night of poor ventilation with high concentrations of CO2 (3000 ppm) and other bio effluents (The order of the three conditions are randomized)

Other: Good ventilation
Good ventilation with a low concentration of CO2

Other: Ventilation CO2
CO2 High and Good ventilation

Other: Poor Ventilation
Poor ventilation with high concentrations of CO2 and bio effluents

Outcome Measures

Primary Outcome Measures

  1. Reaction time (Simple) [10 hours post start of exposure]

    Reaction time in milliseconds. Outcome from CANTAB RTI Simple.

Secondary Outcome Measures

  1. CANTAB global composite score [10 hours post start of exposure]

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

  2. Reaction Time (Five-Choice) [10 hours post start of exposure]

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

  3. Sleep efficiency [Sleep measured for 9 hours during exposure in bed from 9 pm to 6 am.]

    Sleep efficiency = Percentage of time in bed spent sleeping.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aarhus University, Department of Public Health, Section for Environment, Occupation and Health Aarhus Denmark DK-8000

Sponsors and Collaborators

  • University of Aarhus

Investigators

  • Principal Investigator: Torben Sigsgaard, Department of Public Health - Institute of Environmental and Occupational Medicine, Aarhus University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT03558698
Other Study ID Numbers:
  • 111017
First Posted:
Jun 15, 2018
Last Update Posted:
Oct 11, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Aarhus
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2018