Obstructive Sleep Apnea (OSA)NCT07023458
The Effects of Hypoxic Burden on Executive Function (EF) in Preschool Children With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea (OSA), run by Mahidol University at 1 site in Thailand.
Trial 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.. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Brief-P
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Siriraj Hospital
Who may be able to join
- Children aged 2-6 years old with OSA
Who cannot join
- Underlying diseases : hypoventilation, neuromuscular diseases, etc.
Trial locations and contacts
1 site in 1 country.
About this study
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..
Read the detailed description
There is no comparison group in this study Participants will performed full night polysomnography, Denver and BRIEF-P test within 3 months.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Brief-P
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief-PDiagnostic test
Executive function test in preschool children with OSA
| Study group | Role | What they receive |
|---|---|---|
| 1 | All participants in the group will undergo polysomnography, Denver test and BRIEF-P test for executive function Receives: Diagnostic Test: Brief-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function from BRIEF-P test
T-scores at or below 59 are considered to be within the typical range
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Mar 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarisa Thawongit, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023458
- Sponsor's protocol ID
- COA119/2025
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hypoxic Burden on Executive Function (EF) in Preschool Children With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07023458
- Acronym / sponsor ID
- COA119/2025
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Brief-PAll participants in the group will undergo polysomnography, Denver test and BRIEF-P test for executive function |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Siriraj Hospital
Key inclusion criteria (1 listed)
- Children aged 2-6 years old with OSA
Key exclusion criteria (1 listed)
- Underlying diseases : hypoventilation, neuromuscular diseases, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief-PExecutive function test in preschool children with OSA | Diagnostic test | 1 |
Primary outcome
Executive function from BRIEF-P test
Time frame: 3 months
T-scores at or below 59 are considered to be within the typical range
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA), run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive function from BRIEF-P test (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.