NCT07020871

Brief Summary

The goal of this observational study is to learn about the status quo and relationship of dry eye, problematic smartphone use, bedtime procrastination, and sleep in adolescents and young adults. The main questions it aims to answer are:

  • Is there a positive correlation between problematic smartphone use and dry eye?
  • Is problematic smartphone use positively correlated with bedtime procrastination?
  • Is bedtime procrastination negatively correlated with sleep quality?
  • Is there a negative correlation between sleep quality and dry eye?
  • Is there a negative correlation between problematic smartphone use and sleep quality?
  • Is there a positive correlation between bedtime procrastination and dry eye?
  • Do bedtime procrastination and sleep quality serve as mediating factors in the relationship of problematic smartphone use and dry eye? Participants will be asked to complete several questionnaires and dry eye related examinations.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
453

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2025Jun 2026

First Submitted

Initial submission to the registry

June 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 20, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

June 5, 2025

Last Update Submit

July 5, 2025

Conditions

Keywords

dry eye diseaseproblematic smartphone usesleep qualitybedtime procrastinationadolescents and young adults

Outcome Measures

Primary Outcomes (4)

  • Dry eye symptoms

    Ocular Surface Disease Index scale with 12-item will be used to measure dry eye symptoms. The scale uses Likert 5 comments, with a total score ranging from 0 to 100. And the total score reaching or exceeding 13 points indicates that participants exhibit symptoms of dry eye.

    baseline

  • Problematic smartphone use

    The 10-item Smartphone Addiction Scale Short Version will be used to measure the problematic smartphone use. The scale uses Likert 6 comments, with a total score ranging from 10 to 60. And higher scores indicate more severe problematic smartphone use.

    baseline

  • sleep quality

    The Pittsburgh Sleep Quality Index scale is used to measure participants' sleep quality. The total score ranges from 0 to 21. Higher scores indicate lower quality of sleep.

    baseline

  • bedtime procrastination

    There are 9 items in the Bedtime Procrastination Scale, which is used to measure participants' bedtime procrastination. The scale uses 5-point scale, with a total score ranging from 9 to 45. And higher scores indicate more severe procrastination before sleep.

    baseline

Secondary Outcomes (2)

  • Perceived level of stress

    baseline

  • non-invasive tear film break-up time

    baseline

Other Outcomes (3)

  • Tear meniscus height

    baseline

  • Meibomian gland loss

    baseline

  • Lipid layer thickness (LLT) and blinking pattern

    baseline

Study Arms (1)

Investigation Team

1. After informed consent, adolescents and young adults aged 14-35 years old (including 14,35 years old) are assessed by questionnaires and dry eye related examinations. 2. The main content is Investigating the relationship among dry eye disease, problematic smartphone use, bedtime procrastination, and sleep quality.

Eligibility Criteria

Age14 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

General adolescents and young adults between 14-35 years old

You may qualify if:

  • Adolescents and young adults aged 14 to 35 (including 14,25 years old) ;
  • Agree to participate in the studies

You may not qualify if:

  • Unable to communicate normally;
  • With ocular surface diseases other than dry eye and autoimmune diseases;
  • Use drugs that may cause damage to the ocular surface, such as anti glaucoma drugs, antidepressants, sex hormones, chemotherapy drugs, etc.;
  • With a history of eye trauma or eye surgery;
  • With a history of wearing contact lenses within the past month;
  • Pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Dry Eye SyndromesSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Wei Xia PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 13, 2025

Study Start

July 20, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations