Condition category
Not Applicable
Date applied
15/06/2020
Date assigned
28/07/2020
Last edited
28/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Natural light is changing in intensity and spectrum during the day. Experiencing it is a crucial factor, influencing the circadian rhythm cognitive performance, concentration and daytime sleepiness. This is also true for students. Intelligent shading systems can improve the indoor daylight supply. This controlled, single-blinded longitudinal intervention study investigated the effects of a new shading system on cognitive performance, stress and wellbeing in healthy middle school students.

What does the study involve?
New shading systems will be installed in four classrooms of the middle school of Adnet (Salzburg, Austria). In two classrooms conventional shading systems will be installed (control-condition). The other two classrooms will be equipped with the new shading system. This new shading system leads much more daylight into the building, than conventional systems, while reflecting direct sunlight to prevent the building from overheating. During the intervention period, all children will live at home, maintaining their usual lifestyle. Participating students will be asked to perform a concentration test, to fill out some questionnaires and salivary samples will be collected.

Who can participate?
Only students from the 7th and 8th grade of the middle school of Adnet, Salzburg, Austria can participate in this study.

What are the possible benefits and risks of participating?
No risks are expected.

Where is the study run from?
The Paracelsus Medical University of Salzburg (Austria)

When is the study starting and how long is it expected to run for?
January 2015 to June 2016

Who is funding the study?
This project is funded by Salzburg state (funding scheme: Trans4Tech)

Who is the main contact?
Dr Arnulf Hartl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Arnulf Josef Hartl

ORCID ID

http://orcid.org/0000-0001-9626-6425

Contact details

Paracelsus Medical University Salzburg
Institute of Ecomedicine
Salzburg
5020
Austria
+43 (0)662 2420 80530
arnulf.hartl@pmu.ac.at

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

415-E/1857/2-2015

Study information

Scientific title

Physiological and psychological effects of indoor daylight control on middle school students

Acronym

Trans4Light

Study hypothesis

Primary Hypothesis: An increased indoor daylight supply improves cognitive performance, quality of life and stress in middle school students.
Secondary Hypothesis: An increased indoor daylight supply in classrooms reduces power consumption.

Ethics approval

Approved 16/03/2015, Ethics Committee of Salzburg (Stefan-Stief-Gasse 2, Postfach 527, 5010 Salzburg, Austria; +43 (0)662 8042 0; ethikkommission@salzburg.gv.at), ref: 415-E/1857/2-2015

Study design

Controlled single-blinded longitudinal intervention study with two intervention groups and constructive implementation

Primary study design

Interventional

Secondary study design

Controlled intervention study with constructive implementation

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participants information sheet

Condition

Cognitive performance, quality of life and stress in middle school students

Intervention

New shading systems were installed in four identical classrooms in the selected middle school. These shading blades prevent the building from overheating in summer months. Common blades (schlotterer 80R) were installed in two classrooms, while two classrooms were equipped with shading blades in a special design (schlotterer RETROLux 80D), which enables them to reflect more daylight into the rooms. All students, parents and teachers were blinded. The RETROLux 80D blades block direct sunlight in summer, while reflecting more non-direct daylight than conventional shading systems. The participating students spent on average 5 days per week and 5-8 h per day in their classrooms. During the intervention, all children lived at home, maintaining their usual lifestyle.

One class of each grade was randomly assigned to the special shading system. The intervention time was 3 semesters (~1.5 years). During the intervention time of 1.5 years, data was collected at five timepoints:
T1 = baseline, March 20; T2 = June 2015; T3 = November 2015; T4 = March 2016; T5 = June 2016.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Salivary cortisol (as a biomarker for stress) measured by ELISA at T2-T5
2. Salivary melatonin (as a biomarker for circadian rhythm) measured by ELISA at T2-T5
2. Daytime sleepiness assessed using the Pediatric Daytime Sleepiness Scale (PDSS, German translation) questionnaire at T1- T5

T1 = baseline, March 20; T2 = June 2015; T3 = November 2015; T4 = March 2016; T5 = June 2016.

Secondary outcome measures

1. Attention and concentration assessed using the d2-Revision (d2-R) test at T1-T5
2. Health-related quality of life in children assessed using the KINDL-R questionnair at T1-T5
3. Stress processing assessed using the German Coping Questionnaire for Children and Adolescents (SVF-KJ) questionnaire at T1-T5
4. Participant's assessment of stress measured using an inverse visual analogue scale measured every week during the intervention period of 3 semesters
5. Participant's assessment of daytime sleepiness measured using an inverse visual analogue scale measured every week during the intervention period of 3 semesters
6. Participant's assessment of concentration measured using an inverse visual analogue scale measured every week during the intervention period of 3 semesters
7. Participant's assessment of wellbeing measured using an inverse visual analogue scale measured every week during the intervention period of 3 semesters
8. Participant's assessment of fatigue measured using an inverse visual analogue scale measured every week during the intervention period of 3 semesters
9. Daylight and artificial light composition measured using a spectrometer continuously throughout the intervention
10. Indoor carbon dioxide concentration measured using a CO2-meter continuously throughout the intervention
11. Room temperature measured using a digital hygro-thermometer continuously throughout the intervention
12. Relative humidity measured using a digital hygro-thermometer continuously throughout the intervention
13. Power consumption measured using a power meter continuously throughout the intervention

T1 = baseline, March 20; T2 = June 2015; T3 = November 2015; T4 = March 2016; T5 = June 2016.

Overall trial start date

01/01/2015

Overall trial end date

23/06/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Students of the 7th and 8th grade of the Middle School of Adnet (aged 12-15)

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

100 students

Total final enrolment

85

Participant exclusion criteria

Students of the 5th and 6th grade of the Middle School of Adnet

Recruitment start date

17/03/2015

Recruitment end date

17/04/2015

Locations

Countries of recruitment

Austria

Trial participating centre

Paracelsus Medical University Salzburg
Institute of Ecomedicine Strubergasse 22
Salzburg
5020
Austria

Sponsor information

Organisation

Paracelsus Medical University

Sponsor details

Research Office
Strubergasse 21
Salzburg
5020
Austria
+43 (0)662 2420-80280
d.koelblinger@pmu.ac.at

Sponsor type

University/education

Website

https://www.pmu.ac.at/

Funders

Funder type

Government

Funder name

Salzburg state (funding scheme: Trans4Tech)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in autumn 2020.

IPD sharing statement:
Data can be requested from Arnulf Josef Hartl (arnulf.hartl@pmu.ac.at). Data will be available as an Excel sheet and will be shared by email. The data is fully anonymised by 4-digit ID. Consent from participants was obtained to use their data for scientific purposes only. Data will be only accessible for scientific research (e.g. power calculations, meta-analysis).

Intention to publish date

01/10/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/06/2020: Trial's existence confirmed by Ethikkommission für das Bundesland Salzburg [Salzburg state ethics committee].