Evaluation of the effects of the Lili screen on the reading performance of dyslexic adults
| ISRCTN | ISRCTN14080164 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14080164 |
| Protocol serial number | 2025-A00803-46 |
| Sponsor | Lili for Life |
| Funder | Lili for Life |
- Submission date
- 11/12/2025
- Registration date
- 29/05/2026
- Last edited
- 29/05/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background of the study and aims
Dyslexia is a neurodevelopmental disorder linked to brain dysfunction. Its prevalence varies from country to country. To date, it is on the rise, probably due to improved diagnosis and better training of clinicians who treat these patients. Imaging studies (MRI) have reported abnormal processing of visual perception, particularly in the middle temporal lobe of the extrastriate areas, supporting the hypothesis of a visual abnormality in the magnocellular pathway (M cells) in dyslexic individuals. Other studies have shown alterations in the magnocellular system in dyslexia and highlighted the role of this system in the development of normal vision.
To date, no clinical studies have been conducted on the Lili screen. This study is based on the hypothesis that using the Lili screen, with a personalized flicker rate chosen by each subject, for a period of 28 days could significantly improve reading comfort in adult dyslexic subjects. The main objective is to compare the change in reading speed between day 0 and day 28 in dyslexic subjects using the Lili screen in ON mode with the change in reading speed in dyslexic subjects using the Lili screen in OFF mode. Secondary objectives include measuring the effect of the use of the Lili screen over 28 days on (i) eye movement patterns (ii) text comprehension (iii) reading fluidity (iv) oralization capacity (v) oculomotor pattern (vi) visual exploration strategy.
Who can participate ?
Healthy working adult volunteers aged between 18 and 45.
What does the study involve ?
The study involves (i) tests realized on day 0 (ii) the use of the Lili screen over 28 days in the office and at home and (iii) tests realized after 28 days of use of the screen.
What are potential benefits and risks of participating ?
The benefits could be an improvement in all or some of : (i) eye movement patterns (ii) text comprehension (iii) reading fluidity (iv) oralisation capacity (v) oculomotor pattern (vi) visual exploration strategy (vii) reading speed.
There is no risk identified.
Where is the study run from ?
The study is run from various locations in France (universities, companies’ offices and Hôpital Robert Debré).
When is the study starting and when is it expected to end ?
The study starts in September 2025 and runs until December 2026, if not extended.
Who is finding the study ?
Lili For Life, France.
Who is the main contact?
Maria-Pia Bucci, maria-pia.bucci@cnrs.fr
Contact information
Scientific, Principal investigator
Hôpital Universitaire Robert Debré
63, boulevard Sérurier
Paris
75015
France
| 0000-0001-6673-2026 | |
| Phone | + 33 1 40 03 24 79 |
| maria-pia.bucci@cnrs.fr |
Public
Le Village by C A
107 Allee Francois Mitterrand
Rouen
76100
France
| Phone | +33 2 78 92 00 10 |
|---|---|
| contact@liliforlife.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Parallel |
| Purpose | Device feasibility, Supportive care |
| Scientific title | Dyslexic adults from 18 to 45 years old. Measuring the effects of the use of the LILI screen, on day 0 and over 28 days, with the use of a lookalike placebo screen over the same period. |
| Study acronym | ADULTDYSLIGHT |
| Study objectives | The use of the LILI screen over a period of 28 days contributes to an increase in the speed of reading as well as to an improved comprehension of documents read. |
| Ethics approval(s) |
1. Approved 18/07/2025, Comité de Protection des Personnes Nord Ouest IV (6, rue du Professeur Lagueuse - CHU LILLE - CS 70001, LILLE, 59037, France; + 33 3 20 44 41 65; cppnordouestiv@univ-lille.fr), ref: 25.01308.000410 2. Approved 14/08/2025, National Commission for Information Technology and Freedoms (Commission Nationale Informatique & Libertés - CNIL) (3, place de Fontenoy - TSA 80715, Paris, 75034, France; + 33 1 53 73 22 22; agaignon@cnil.fr), ref: PHT/AGN/AR255494 - DR-2025-189 - Demande d’autorisation n° 925125v1 |
| Health condition(s) or problem(s) studied | Dyslexic persons' reading difficulties |
| Intervention | The randomization is available in a specific folder, not accessible to the investigator, of the e-Clinical Data Management platform. The subjects are randomized following the block-balancing randomization method to an active group and a placebo group. On the first day of taking part in the study, each participant goes through the first leg of protocolled tests with the Lili screen in mode Off and in mode On. The starting mode (On or Off) is allocated randomly, and neither the participant nor the investigator knows the nature of the starting mode. After the participant has gone through the tests, he/she is randomly allocated two, three and four screens depending on his/her own particular work circumstances (one or two for the office, one or two for home-office). The screens are either On-screens or placebos (Off-Screens). Off-screens and On-screens are lookalikes. Neither the participant nor the investigator is informed of the nature of the screens the participant receives. The participant then works 28 days with the Lili screens in his/her usual office / home-office environment from where the participant’s original screens have been removed. After four weeks of working with the Lili screens, the participant takes part in the second leg of protocolled tests. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | LILI screen |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
1. Reading speed of dyslexic subjects using the Lili screen in OFF mode and then in ON mode measured using an eye-tracker (seconds) at baseline and day 28 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Employee, Learner/student, Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Male or female 2. Aged 18 to 45 3. Whose native language is French, 4. Diagnosed with dyslexia (DSM 5, APA. 2013) 5. With normal or corrected vision (≥ 8/10 in each eye) 6. Affiliated to the French social security system. |
| Key exclusion criteria | 1. Subjects with comorbidities (other neurological disorders and/or autism spectrum disorders, dyspraxia, etc.) 2. Subjects with visual impairments (amblyopia, strabismus, etc.) 3. Subjects undergoing psychotropic treatment 4. Subjects with epilepsy 5. Subjects who abuse alcohol (more than 2 drinks per day) 6. Subjects who smoke (≥ 4 cigarettes per day) 7. Subjects who use psychoactive substances such as: 7.1. Psycho-dysleptics: narcotics (heroin, morphine and derivatives), cannabis, ketamine, GHB, LSD, psilocybin, ibogaine 7.2. Psycholeptics: benzodiazepines and related substances (zopiclone, zolpidem) 7.3. Psycho-analeptics: cocaine, amphetamines 8. Pregnant or breastfeeding women 9. Protected adults |
| Date of first enrolment | 08/09/2025 |
| Date of final enrolment | 01/12/2026 |
Locations
Countries of recruitment
- France
Study participating centres
Aubervilliers
93300
France
Niort
79000
France
2, avenue Gambetta
Courbevoie
92400
France
Amiens Cedex 01
80025
France
Issy-les-Moulineaux
92130
France
Paris
75019
France
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from October 2027. The contact name is Maria-Pia Bucci : maria-pia.bucci@cnrs.fr |
Editorial Notes
12/12/2025: Study’s existence confirmed by the National Commission for Information Technology and Freedoms (Commission Nationale Informatique & Libertés - CNIL), France.