Cognitive Impairment, MildNCT03558698
Are Cognition and Sleep Affected by Exposure to Carbon Dioxide and Bio Effluents During Sleep?
A study testing Good ventilation, Ventilation CO2 and Poor Ventilation in people with Cognitive Impairment, Mild and Sleep, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Mild, Sleep, Environmental Exposure
- What is being tested?
- Good ventilation, Ventilation CO2 and Poor Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Jan 2018to 22 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Unable to spend three nights (separated by seven days) in the climate chambers
- Conditions that prevent safe access to the chambers such as claustrophobia
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department of Public Health, Section for Environment, Occupation and Health
Aarhus, DK-8000
About this study
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
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.
Read more
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.
- Conditions
- Cognitive Impairment, Mild, Sleep, Environmental Exposure
- Being tested
- Good ventilation, Ventilation CO2, Poor Ventilation
- Keywords
- cognition, sleep, carbon dioxide, bio effluents
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Good ventilationOther
Good ventilation with a low concentration of CO2
Ventilation CO2Other
CO2 High and Good ventilation
Poor VentilationOther
Poor ventilation with high concentrations of CO2 and bio effluents
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | * 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) Receives: Other: Good ventilation; Other: Ventilation CO2; Other: Poor Ventilation |
| Group 2 | Other | * 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) Receives: Other: Good ventilation; Other: Ventilation CO2; Other: Poor Ventilation |
| Group 3 | Other | * 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) Receives: Other: Good ventilation; Other: Ventilation CO2; Other: Poor Ventilation |
| Group 4 | Other | * 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) Receives: Other: Good ventilation; Other: Ventilation CO2; Other: Poor Ventilation |
| Group 5 | Other | * 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) Receives: Other: Good ventilation; Other: Ventilation CO2; Other: Poor Ventilation |
| Group 6 | Other | * 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) Receives: Other: Good ventilation; Other: Ventilation CO2; Other: Poor Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time (Simple)
Reaction time in milliseconds. Outcome from CANTAB RTI Simple.
Measured: 10 hours post start of exposure
Secondary outcomes (3)
CANTAB global composite score
CANTAB global composite score = outcomes from CANTAB transformed into a global composite score.
Measured: 10 hours post start of exposure
Reaction Time (Five-Choice)
Reaction time in milliseconds. Outcome from CANTAB RTI Five-Choice.
Measured: 10 hours post start of exposure
Sleep efficiency
Sleep efficiency = Percentage of time in bed spent sleeping.
Measured: Sleep measured for 9 hours during exposure in bed from 9 pm to 6 am.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start23 Jan 2018
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment, MildStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torben Sigsgaard, Principal investigator, Department of Public Health - Institute of Environmental and Occupational Medicine, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558698
- Sponsor's protocol ID
- 111017
- Status last verified
- May 2018
- First submitted
- 16 May 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03558698
- Acronym / sponsor ID
- 111017
- Conditions
- Cognitive Impairment, Mild, Sleep, Environmental Exposure
- Keywords
- cognition, sleep, carbon dioxide, bio effluents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: Good ventilation, Other: Ventilation CO2, Other: Poor Ventilation* 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) |
| Group 2 | Other | Other: Good ventilation, Other: Ventilation CO2, Other: Poor Ventilation* 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) |
| Group 3 | Other | Other: Good ventilation, Other: Ventilation CO2, Other: Poor Ventilation* 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) |
| Group 4 | Other | Other: Good ventilation, Other: Ventilation CO2, Other: Poor Ventilation* 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) |
| Group 5 | Other | Other: Good ventilation, Other: Ventilation CO2, Other: Poor Ventilation* 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) |
| Group 6 | Other | Other: Good ventilation, Other: Ventilation CO2, Other: Poor Ventilation* 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) |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to spend three nights (separated by seven days) in the climate chambers
- Conditions that prevent safe access to the chambers such as claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Good ventilationGood ventilation with a low concentration of CO2 | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Ventilation CO2CO2 High and Good ventilation | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Poor VentilationPoor ventilation with high concentrations of CO2 and bio effluents | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Reaction time (Simple)
Time frame: 10 hours post start of exposure
Reaction time in milliseconds. Outcome from CANTAB RTI Simple.
3 secondary outcomes
CANTAB global composite score
Time frame: 10 hours post start of exposure
Reaction Time (Five-Choice)
Time frame: 10 hours post start of exposure
Sleep efficiency
Time frame: Sleep measured for 9 hours during exposure in bed from 9 pm to 6 am.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torben Sigsgaard principal investigator
Department of Public Health - Institute of Environmental and Occupational Medicine, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Good ventilation, Ventilation CO2 and Poor Ventilation in people with Cognitive Impairment, Mild and Sleep, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time (Simple) (time frame: 10 hours post start of exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.