NCT07023458

Brief Summary

The goal of this observational study is to study the effect of hypoxic burden on executive function in preschool children aged 2-6 years who have OSA. The main question it aims to answer is Effect of hypoxic burden from OSA to executive function measured by BRIEF-P in preschool children..

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 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

First Submitted

Initial submission to the registry

June 7, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

June 7, 2025

Last Update Submit

July 1, 2025

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

  • Executive function from BRIEF-P test

    T-scores at or below 59 are considered to be within the typical range

    3 months

Study Arms (1)

1

All participants in the group will undergo polysomnography, Denver test and BRIEF-P test for executive function

Diagnostic Test: Brief-P

Interventions

Brief-PDIAGNOSTIC_TEST

Executive function test in preschool children with OSA

1

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Siriraj Hospital

You may qualify if:

  • Children aged 2-6 years old with OSA

You may not qualify if:

  • Underlying diseases : hypoventilation, neuromuscular diseases, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Sarisa Thawongit, Pediatric sleep medicine

CONTACT

668-654-00288sarisa.thw@mahidol.ac.th

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2025

First Posted

June 17, 2025

Study Start

August 1, 2025

Primary Completion

February 1, 2026

Study Completion

May 1, 2026

Last Updated

July 4, 2025

Record last verified: 2025-07

Locations

TH(1)