Obstructive Sleep Disordered BreathingPTOSNCT06792045
Prediction of Tongue Base Obstruction During Sleep
An observational study of Obstructive Sleep Disordered Breathing, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study investigates the hypothesis that, in children, tongue motor functions can predict both the anatomical site and the degree of upper airway obstruction contributing to obstructive sleep-disordered breathing. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Obstructive Sleep Disordered Breathing
- What is being tested?
- Physiotherapist assessment, ENT assessment and Drug-Induced Sleep Endoscopy
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Aug 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be recruited during ENT consultations.
Who may be able to join
- Age between 6 and 17 years old
- Medical diagnosis of obstructive sleep-disordered breathing requiring surgical removal of tonsils (partial or total) and/or adenoids
- Positive Pediatric Sleep Questionnaire (8 or more positive responses)
- Eligibility for surgical intervention
Who cannot join
- Neurological, cardiac, or respiratory comorbidity other than obstructive sleep-disordered breathing
- Previous surgery of the upper airway or oral cavity
- History of or current head or neck cancer
- Cranial, upper airway, or oral cavity malformation
- Contraindication to performing endoscopy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pierre Cnockaert, PT contact
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
William Poncin, Pr., Dr., +32470592032, william.poncin@uclouvain.be
About this study
Official title: Tongue Motor Functions Assessment as a Screening Tool for Obstructive Sleep Disordered Breathing in Children
This study investigates the hypothesis that, in children, tongue motor functions can predict both the anatomical site and the degree of upper airway obstruction contributing to obstructive sleep-disordered breathing.
Read the detailed description
Patients will be enrolled during their visit to the ENT physician. Subsequently, their tongue motor functions will be assessed during their pre-surgical appointment. Finally, they will undergo a drug-induced sleep endoscopy prior to their surgery.
- Conditions
- Obstructive Sleep Disordered Breathing
- Being tested
- Physiotherapist assessment, ENT assessment, Drug-Induced Sleep Endoscopy
- Keywords
- obstructive sleep disordered breathing, pediatrics, sleep, obstructive sleep apnea, snoring, tongue
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist assessmentOther
- Tongue motor skills (Tongue pressures and tongue mobility, assessed through the Iowa Oral Performance Instrument and the Motricité Bucco-Linguo-Faciale tongue subscore, respectively)
- Tongue restriction of mobility due to its frenulum (assessed through the Quick Tongue-Tie assessment tool)
- Breathing Pattern (questionnaire from Abreu RR, Rocha RL, Lamounier JA, Guerra AF. Etiology, clinical manifestations and concurrent findings in mouth-breathing children. J Pediatr (Rio J). 2008;84(6):529-535.).
ENT assessmentOther
Data from the ENT appointment will be collected (e.g., sex, height, weight)
Drug-Induced Sleep EndoscopyDiagnostic test
A Drug-Induced Sleep Endoscopy will be performed, recorded, and evaluated by two blinded raters using the IPSES scale.
| Study group | Role | What they receive |
|---|---|---|
| Children with obstructive sleep disordered breathing | Not described Receives: Other: Physiotherapist assessment; Other: ENT assessment; Diagnostic Test: Drug-Induced Sleep Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of tongue base obstruction
Evaluated through the IPSES scoring during a Drug Induced Sleep Endoscopy (DISE)
Measured: During the planned surgery
Secondary outcomes (4)
Breathing pattern
Presence or absence of mouth breathing will be assessed with the mouth breathing questionnaire from Abreu et al. (2018).
Measured: During the pre-surgical appointment
Tongue mobility (MBLF score)
Assessed through the Motricité Bucco-Linguo-Faciale (MBLF) tongue test score
Measured: During the pre-surgical appointment
Tongue pressures (kPa)
Tongue pressures will be measured with the Iowa Oral Performance Instrument (IOPI), in kPa, during a protrusion, an elevation, and a swallowing task.
Measured: During the pre-surgical appointment
Tongue mobility restriction due to its frenulum ratio (%)
The ratio between the maximal comfortable mouth opening, with the tongue tip to the incisive papilla, and the maximal comfortable mouth opening, will be computed.
Measured: During the pre-surgical appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start22 Aug 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Disordered BreathingStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Poncin, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792045
- Sponsor's protocol ID
- PTOS
- Acronym
- PTOS
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2024
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Motor Functions Assessment as a Screening Tool for Obstructive Sleep Disordered Breathing in Children
- ClinicalTrials.gov ID
- NCT06792045
- Acronym / sponsor ID
- PTOS / PTOS
- Conditions
- Obstructive Sleep Disordered Breathing
- Keywords
- obstructive sleep disordered breathing, pediatrics, sleep, obstructive sleep apnea, snoring, tongue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Jan 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.
This study investigates the hypothesis that, in children, tongue motor functions can predict both the anatomical site and the degree of upper airway obstruction contributing to obstructive sleep-disordered breathing.
Detailed description
Patients will be enrolled during their visit to the ENT physician. Subsequently, their tongue motor functions will be assessed during their pre-surgical appointment. Finally, they will undergo a drug-induced sleep endoscopy prior to their surgery.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with obstructive sleep disordered breathing | – | Other: Physiotherapist assessment, Other: ENT assessment, Diagnostic Test: Drug-Induced Sleep Endoscopy |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be recruited during ENT consultations.
Key inclusion criteria (4 listed)
- Age between 6 and 17 years old
- Medical diagnosis of obstructive sleep-disordered breathing requiring surgical removal of tonsils (partial or total) and/or adenoids
- Positive Pediatric Sleep Questionnaire (8 or more positive responses)
- Eligibility for surgical intervention
Key exclusion criteria (5 listed)
- Neurological, cardiac, or respiratory comorbidity other than obstructive sleep-disordered breathing
- Previous surgery of the upper airway or oral cavity
- History of or current head or neck cancer
- Cranial, upper airway, or oral cavity malformation
- Contraindication to performing endoscopy
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 |
|---|---|---|
| Physiotherapist assessment* Tongue motor skills (Tongue pressures and tongue mobility, assessed through the Iowa Oral Performance Instrument and the Motricité Bucco-Linguo-Faciale tongue subscore, respectively) * Tongue restriction of mobility due to its frenulum (assessed through the Quick Tongue-Tie assessment tool) * Breathing Pattern (questionnaire from Abreu RR, Rocha RL, Lamounier JA, Guerra AF. Etiology, clinical manifestations and concurrent findings in mouth-breathing children. J Pediatr (Rio J). 2008;84(6):529-535.). | Other | Children with obstructive sleep disordered breathing |
| ENT assessmentData from the ENT appointment will be collected (e.g., sex, height, weight) | Other | Children with obstructive sleep disordered breathing |
| Drug-Induced Sleep EndoscopyA Drug-Induced Sleep Endoscopy will be performed, recorded, and evaluated by two blinded raters using the IPSES scale. | Diagnostic test | Children with obstructive sleep disordered breathing |
Primary outcome
Extent of tongue base obstruction
Time frame: During the planned surgery
Evaluated through the IPSES scoring during a Drug Induced Sleep Endoscopy (DISE)
4 secondary outcomes
Breathing pattern
Time frame: During the pre-surgical appointment
Tongue mobility (MBLF score)
Time frame: During the pre-surgical appointment
Tongue pressures (kPa)
Time frame: During the pre-surgical appointment
Tongue mobility restriction due to its frenulum ratio (%)
Time frame: During the pre-surgical appointment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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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.
Pierre Cnockaert, PT contact
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 Disordered Breathing, run by Université Catholique de Louvain at 1 site in Belgium.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 May 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Poncin, Pr, Dr. (+32470592032, william.poncin@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of tongue base obstruction (time frame: During the planned surgery). 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 4 May 2026.