Healthy ChildrenNCT04642781
Measurement of Eye Movements While Reading a German Text
An observational study of Healthy Children, run by University of Basel at 1 site in Switzerland.
Trial summary
To establish normative value for reading parameters in healthy children of primary school age and in grades 2-5. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- reading of a text
- How many people
- 127 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Mar 2018to 30 Jul 2020
- Phase
- Observational
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children recruited from 4 primary schools in German speaking Switzerland
Who may be able to join
- 8-13 years
- child consent
- parental consent
Who cannot join
- unability to read
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Basel, University Eye Hospital Basel
Basel, 4031
About this study
To establish normative value for reading parameters in healthy children of primary school age and in grades 2-5.
Read the detailed description
Following initial assessment of feasibility, recruitment is expanded to children attending grades 2-5 recruited from 4 different primary schools in German speaking Switzerland. Two texts of The New International Reading Speed Test (IReST) of similar difficulty are presented on a laptop in randomized order. Children are asked to read the text aloud while eye movements are recorded with an eye tracking bar. The following parameters are analysed: reading speed (words/minute), number of saccades, number of fixations.
- Conditions
- Healthy Children
- Being tested
- reading of a text
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reading of a textDiagnostic test
Reading of 2 IRest Texts presented on a laptop in randomized order while eye movements are recorded with a tracking bar.
| Study group | Role | What they receive |
|---|---|---|
| healthy children aged 8-13years (schoolgrade 2-5) | Primary school children are asked to read a German text presented on a laptop screen Receives: Diagnostic Test: reading of a text |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading speed
words read per minute
Measured: 21 months
number of saccades and fixations
how stable are the eyes while reading out loud
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start30 Mar 2018
- Primary completion30 Dec 2019
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Palmowski-Wolfe, University of Basel
- Investigators
- Anja M Palmowski-Wolfe, Prof, Principal investigator, University Basel, University Eye Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642781
- Sponsor's protocol ID
- 2018-00283
- Other IDs
- 2018
- Status last verified
- Jun 2023
- First submitted
- 18 Nov 2020
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing through publication
Publications
Wertli J, Schotzau A, Trauzettel-Klosinski S, Palmowski-Wolfe A. Feasibility of Eye Movement Recordings with the SMI Tracking Bar in 10- to 11-Year-Old Children Performing a Reading Task. Klin Monbl Augenheilkd. 2020 Apr;237(4):510-516. doi: 10.1055/a-1101-9204. Epub 2020 Apr 24.
PubMed 32330981Wertli J, Schotzau A, Palmowski-Wolfe A. The Influence of Age on Eye Movements during Reading in Early Elementary School Children. Klin Monbl Augenheilkd. 2023 Apr;240(4):591-598. doi: 10.1055/a-2045-7271. Epub 2023 Apr 25.
PubMed 37164411
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Eye Movements While Reading a German Text
- ClinicalTrials.gov ID
- NCT04642781
- Acronym / sponsor ID
- 2018-00283
- Conditions
- Healthy Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 24 Nov 2020 (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.
To establish normative value for reading parameters in healthy children of primary school age and in grades 2-5.
Detailed description
Following initial assessment of feasibility, recruitment is expanded to children attending grades 2-5 recruited from 4 different primary schools in German speaking Switzerland. Two texts of The New International Reading Speed Test (IReST) of similar difficulty are presented on a laptop in randomized order. Children are asked to read the text aloud while eye movements are recorded with an eye tracking bar. The following parameters are analysed: reading speed (words/minute), number of saccades, number of fixations.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy children aged 8-13years (schoolgrade 2-5) | – | Diagnostic Test: reading of a textPrimary school children are asked to read a German text presented on a laptop screen |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children recruited from 4 primary schools in German speaking Switzerland
Key inclusion criteria (3 listed)
- 8-13 years
- child consent
- parental consent
Key exclusion criteria (1 listed)
- unability to read
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 |
|---|---|---|
| reading of a textReading of 2 IRest Texts presented on a laptop in randomized order while eye movements are recorded with a tracking bar. | Diagnostic test | healthy children aged 8-13years (schoolgrade 2-5) |
Primary outcome
Reading speed
Time frame: 21 months
words read per minute
number of saccades and fixations
Time frame: 21 months
how stable are the eyes while reading out loud
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 23 Jun 2023.
- Results publication: PubMed 32330981Wertli J, Schotzau A, Trauzettel-Klosinski S, Palmowski-Wolfe A. Feasibility of Eye Movement Recordings with the SMI Tracking Bar in 10- to 11-Year-Old Children Performing a Reading Task. Klin Monbl Augenheilkd. 2020 Apr;237(4):510-516. doi: 10.1055/a-1101-9204. Epub 2020 Apr 24.
- Results publication: PubMed 37164411Wertli J, Schotzau A, Palmowski-Wolfe A. The Influence of Age on Eye Movements during Reading in Early Elementary School Children. Klin Monbl Augenheilkd. 2023 Apr;240(4):591-598. doi: 10.1055/a-2045-7271. Epub 2023 Apr 25.
- Individual participant dataSharing planned: No. Sharing through publication
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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.
Anja M Palmowski-Wolfe, Prof principal investigator
University Basel, University Eye Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Children, run by University of Basel at 1 site in Switzerland.
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 1 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 23 Jun 2023. 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 Switzerland. 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?
Reading speed (time frame: 21 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642781, which also lists 2 linked publications.
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 23 Jun 2023.