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

Primary Purpose

Cognitive Impairment, Mild, Sleep, Environmental Exposure

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Good ventilation
Ventilation CO2
Poor Ventilation
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment, Mild focused on measuring cognition, sleep, carbon dioxide, bio effluents

Eligibility Criteria

10 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Group 6

Arm Description

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)

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)

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)

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)

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)

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)

Outcomes

Primary Outcome Measures

Reaction time (Simple)
Reaction time in milliseconds. Outcome from CANTAB RTI Simple.

Secondary Outcome Measures

CANTAB global composite score
CANTAB global composite score = outcomes from CANTAB transformed into a global composite score.
Reaction Time (Five-Choice)
Reaction time in milliseconds. Outcome from CANTAB RTI Five-Choice.
Sleep efficiency
Sleep efficiency = Percentage of time in bed spent sleeping.

Full Information

First Posted
May 16, 2018
Last Updated
October 10, 2018
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT03558698
Brief Title
Are Cognition and Sleep Affected by Exposure to Carbon Dioxide and Bio Effluents During Sleep?
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
June 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Mild, Sleep, Environmental Exposure
Keywords
cognition, sleep, carbon dioxide, bio effluents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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).
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
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)
Arm Title
Group 2
Arm Type
Other
Arm Description
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)
Arm Title
Group 3
Arm Type
Other
Arm Description
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)
Arm Title
Group 4
Arm Type
Other
Arm Description
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)
Arm Title
Group 5
Arm Type
Other
Arm Description
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)
Arm Title
Group 6
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Good ventilation
Intervention Description
Good ventilation with a low concentration of CO2
Intervention Type
Other
Intervention Name(s)
Ventilation CO2
Intervention Description
CO2 High and Good ventilation
Intervention Type
Other
Intervention Name(s)
Poor Ventilation
Intervention Description
Poor ventilation with high concentrations of CO2 and bio effluents
Primary Outcome Measure Information:
Title
Reaction time (Simple)
Description
Reaction time in milliseconds. Outcome from CANTAB RTI Simple.
Time Frame
10 hours post start of exposure
Secondary Outcome Measure Information:
Title
CANTAB global composite score
Description
CANTAB global composite score = outcomes from CANTAB transformed into a global composite score.
Time Frame
10 hours post start of exposure
Title
Reaction Time (Five-Choice)
Description
Reaction time in milliseconds. Outcome from CANTAB RTI Five-Choice.
Time Frame
10 hours post start of exposure
Title
Sleep efficiency
Description
Sleep efficiency = Percentage of time in bed spent sleeping.
Time Frame
Sleep measured for 9 hours during exposure in bed from 9 pm to 6 am.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben Sigsgaard
Organizational Affiliation
Department of Public Health - Institute of Environmental and Occupational Medicine, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University, Department of Public Health, Section for Environment, Occupation and Health
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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