Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631339
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Optimizing Light Exposure for Myopia Prevention and Control LightSPAN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Light Exposure for Myopia Prevention and Control LightSPAN
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LightSPAN
Brief Summary:
The goal of this clinical trial is to evaluate whether the optimization of daily exposure to light in primary school children can lead to better myopia prevention and control The trial also aims to better understand the impact of light exposure on sleep and cognitive performance in children
This trial has 3 arms namely 1 a technical intervention arm 2 a digital intervention arm and 3 a control arm
1 technical intervention - which involves changing of classroom lighting in primary schools to ceiling lights that mimic the spectral composition of sunlight and fluctuates in intensity Parents of children within that arm will have a sham smart-phone application s-LightUP
2 digital intervention - which involves standard classroom lighting and giving parents an interventional smart-phone application i-LightUP that will be coupled with their childs light and activity sensor wrist worn device The interventional app will provide individually tailored recommendation based on their childrens behaviour data feedback that is collected from the light and activity monitoring watch The interventional app would then send reminder promptsnotifications to encourage parents help their children achieve required amounts of myopia-preventive light quantum target set per day
3 Standard care or control group which involves standard classroom lighting and parents having a sham smart-phone application s-LightUP
Participants will
be randomised to receive either no intervention control group technical intervention light intervention that mimics sunlight or digital intervention parents having an app that syncs with childs light and activity sensor which will provide feedback to parents to encourage and recommends increment of outdoor activities and hours
have their myopia progression monitored every 6 monthly and cognitive assessment done once every 3 months over a year
wear the light and activity sensor watches throughout the 1-year study period as much as possible minimum 1 week per month except for wet water activities such as swimming diving and showering for research data collection purpose
This trial has 3 arms namely 1 a technical intervention arm 2 a digital intervention arm and 3 a control arm
1 technical intervention - which involves changing of classroom lighting in primary schools to ceiling lights that mimic the spectral composition of sunlight and fluctuates in intensity Parents of children within that arm will have a sham smart-phone application s-LightUP
2 digital intervention - which involves standard classroom lighting and giving parents an interventional smart-phone application i-LightUP that will be coupled with their childs light and activity sensor wrist worn device The interventional app will provide individually tailored recommendation based on their childrens behaviour data feedback that is collected from the light and activity monitoring watch The interventional app would then send reminder promptsnotifications to encourage parents help their children achieve required amounts of myopia-preventive light quantum target set per day
3 Standard care or control group which involves standard classroom lighting and parents having a sham smart-phone application s-LightUP
Participants will
be randomised to receive either no intervention control group technical intervention light intervention that mimics sunlight or digital intervention parents having an app that syncs with childs light and activity sensor which will provide feedback to parents to encourage and recommends increment of outdoor activities and hours
have their myopia progression monitored every 6 monthly and cognitive assessment done once every 3 months over a year
wear the light and activity sensor watches throughout the 1-year study period as much as possible minimum 1 week per month except for wet water activities such as swimming diving and showering for research data collection purpose
Detailed Description:
The primary objective of the study is to evaluate whether the optimization of daily exposure to light in primary school children can lead to better myopia prevention and control To do so we will evaluate the effectiveness safety and feasibility of
1 Arm 1 technical intervention which involves spectro-temporal refinement of classroom lighting in primary schools using full spectrum light emitting diodes LEDs CCT 4000K in addition to intermittent fluctuations in light levels Parents of children in that arm will have access to a sham version of the LightUP mobile application to facilitate communication with the study team and questionnaire collection during the study
2 Arm 2 digital intervention which involves optimization of daily light exposure using an individualised behaviour-changing smart-phone application Interventional LightUP application coupled with child-worn light and activity sensors to provide parents with an individually tailored recommendation to adapt their childrens behaviour and provide them with the required amounts of myopia-preventive light quantumday standard classroom lighting
As compared to
3 Arm 3 Standard care or control group which involves standard classroom lighting and no access to the interventional version of the LightUP application Parents of children in that arm will have access to a sham version of the LightUP mobile application to facilitate communication with the study team and questionnaire collection during the study
Our study will also lead to the following scalable and implementable outcomes
1 evidence-based lighting designs and policy recommendations for classrooms
2 a user-friendly smart digital eyecare companion that aligns perfectly with Singapores Smart Nation Initiative
A secondary objective of this study is to better understand the impact of light exposure on sleep and cognitive performance in children This will be achieved through continuous wrist actigraphy monitoring and through cognitive assessments performed in classrooms using tablets one tabletchild The assessment consists of validated child-adapted higher cognitive tasks testing the following constructs impulse control spatial working memory content working memory cognitive flexibility reaction time and processing speed
1 Arm 1 technical intervention which involves spectro-temporal refinement of classroom lighting in primary schools using full spectrum light emitting diodes LEDs CCT 4000K in addition to intermittent fluctuations in light levels Parents of children in that arm will have access to a sham version of the LightUP mobile application to facilitate communication with the study team and questionnaire collection during the study
2 Arm 2 digital intervention which involves optimization of daily light exposure using an individualised behaviour-changing smart-phone application Interventional LightUP application coupled with child-worn light and activity sensors to provide parents with an individually tailored recommendation to adapt their childrens behaviour and provide them with the required amounts of myopia-preventive light quantumday standard classroom lighting
As compared to
3 Arm 3 Standard care or control group which involves standard classroom lighting and no access to the interventional version of the LightUP application Parents of children in that arm will have access to a sham version of the LightUP mobile application to facilitate communication with the study team and questionnaire collection during the study
Our study will also lead to the following scalable and implementable outcomes
1 evidence-based lighting designs and policy recommendations for classrooms
2 a user-friendly smart digital eyecare companion that aligns perfectly with Singapores Smart Nation Initiative
A secondary objective of this study is to better understand the impact of light exposure on sleep and cognitive performance in children This will be achieved through continuous wrist actigraphy monitoring and through cognitive assessments performed in classrooms using tablets one tabletchild The assessment consists of validated child-adapted higher cognitive tasks testing the following constructs impulse control spatial working memory content working memory cognitive flexibility reaction time and processing speed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None