The Effects of Hypoxic Burden on Executive Function (EF)... | NCT07023458

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

NCT07023458

Sponsor

Mahidol University

Status

Not yet recruiting

Last Update Posted

Jul 4, 2025Actual

Enrollment

85Estimated

Phase

Not provided

Conditions

Obstructive Sleep Apnea (OSA)

Interventions

Brief-P

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2025Estimated

Primary Completion Date

Feb 2026Estimated

Completion Date

May 2026Estimated

First Submitted Date

Jun 7, 2025

First Submission Date that Met QC Criteria

Jun 7, 2025

First Posted Date

Jun 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2025

Last Update Posted Date

Jul 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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..

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

85Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		All participants in the group will undergo polysomnography, Denver test and BRIEF-P test for executive function	Diagnostic Test: Brief-P

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brief-P	Diagnostic Test	Executive function test in preschool children with OSA	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 2-6 years old with OSA

Exclusion Criteria:

Underlying diseases : hypoventilation, neuromuscular diseases, etc.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Siriraj Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarisa Thawongit, Pediatric sleep medicine	Contact	668-654-00288		sarisa.thw@mahidol.ac.th

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Siriraj Hospital		Bangkok Noi	Bangkok	10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided