The Effects of Hypoxic Burden on Executive Function (EF) in Preschool Children With Obstructive Sleep Apnea

July 1, 2025 updated by: Sarisa Thawongit, Mahidol University

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..

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

There is no comparison group in this study Participants will performed full night polysomnography, Denver and BRIEF-P test within 3 months.

Study Type

Observational

Enrollment (Estimated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Siriraj Hospital

Description

Inclusion Criteria:

  • Children aged 2-6 years old with OSA

Exclusion Criteria:

  • Underlying diseases : hypoventilation, neuromuscular diseases, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
All participants in the group will undergo polysomnography, Denver test and BRIEF-P test for executive function
Diagnostic test: Brief-P
Executive function test in preschool children with OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive function from BRIEF-P test
Time Frame: 3 months
T-scores at or below 59 are considered to be within the typical range
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 7, 2025

First Submitted That Met QC Criteria

June 7, 2025

First Posted (Actual)

June 17, 2025

Study Record Updates

Last Update Posted (Actual)

July 4, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA119/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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