Obstructive Sleep Disordered BreathingNCT07861230
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
An observational study of Obstructive Sleep Disordered Breathing, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The tongue plays a key role in maintaining upper airway patency during sleep, mainly through the genioglossus, the principal pharyngeal dilator muscle. Its dysfunction may be linked to the development of obstructive sleep-disordered breathing (oSDB), a condition affecting more than one in ten children and associated… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Obstructive Sleep Disordered Breathing
- What is being tested?
- Cross-sectional assessment
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2026to 1 Jan 2029
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with obstructive sleep-disordered breathing, with a scheduled polysomnography or who received a polysomnography within the past 6 months, and without any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III
Who may be able to join
- Aged 4 to 17 years
- Scheduled polysomnography, or polysomnography performed within the past 6 months
- Positive Pediatric Sleep Questionnaire (8 "yes" answers or more)
Who cannot join
- Any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III
- Any condition that could interfere with the assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHC MontLégia hospital
Liège, 4000
Matthieu Thimmesch, MD, 0032 4 355 50 20, Matthieu.THIMMESCH@chc.be
About this study
The tongue plays a key role in maintaining upper airway patency during sleep, mainly through the genioglossus, the principal pharyngeal dilator muscle. Its dysfunction may be linked to the development of obstructive sleep-disordered breathing (oSDB), a condition affecting more than one in ten children and associated with cardiovascular and cognitive consequences. Although adenotonsillectomy remains the treatment of choice, it fails in a substantial proportion of cases because of persistent obstruction at other sites, the tongue base being involved in one third of these cases. Therefore, a better characterization of the tongue in children with oSDB is needed, since the extent to which its structure and function contribute to upper airway obstruction in this population remains largely unknown.
Our team has established the reproducibility of tongue function measurements in healthy children and is currently building a reference database. What is still lacking is an assessment of tongue structure and function in children with oSDB. Such data would allow comparison with healthy children, thereby improving the understanding of oSDB pathophysiology and informing clinical management.
Read more
Primary objective: To describe tongue structure and function in children with oSDB.
Secondary objective: To compare tongue structure and function between children with oSDB and healthy children, using data from a previous study conducted in healthy children (TMAC study, UCLouvain).
- Conditions
- Obstructive Sleep Disordered Breathing
- Being tested
- Cross-sectional assessment
- Keywords
- obstructive sleep disordered breathing, children, sleep apnea, tongue
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-sectional assessmentOther
This cross-sectional assessment includes outcomes related to tongue structure, tongue function, and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Unique arm, cross-sectional assessment | Single assessment visit Receives: Other: Cross-sectional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue strength assessment
Maximal pressure exerted by the tongue against an air-filled bulb (in kPa) in protrusion, elevation, and during swallowing.
Measured: At enrollment, during the single study visit (Day 1)
Secondary outcomes (8)
Tongue morphology assessment
Submental ultrasound in frontal and sagittal plane, to assess the thickness of tongue muscles (cm)
Measured: At enrollment, during the single study visit (Day 1)
Tongue frenulum assessment
Tongue range of motion ratio, reflecting the restriction imposed by the lingual frenulum. It is computed as the maximal mouth opening with the tongue tip held at the incisive papilla (mm) divided by the maximal mouth opening (mm).
Measured: At enrollment, during the single study visit (Day 1)
Tongue mobility score
Motricité Bucco-Linguo-Faciale (MBLF) test, where several movements are scored between 0 and 3 regarding muscular contraction or symmetry.
Measured: At enrollment, during the single study visit (Day 1)
Obstructive apnea-hypopnea index
Number of obstructive apneas and hypopneas per hour of sleep (events/hour) assessed through polysomnography
Measured: At enrollment, during the single study visit (Day 1)
Breathing pattern questionnaire
Mouth breathing questionnaire from Abreu et al., considered positive if two major items, or one major and two minor items, are answered "yes"
Measured: At enrollment, during the single study visit (Day 1)
Quality of life questionnaire
PedsQL questionnaire (Pediatric Quality of Life Inventory), divided into parent report and child self-report questionnaires, with several items scored from 0 to 4. Higher scores indicate more problems related to the quality of life.
Measured: At enrollment, during the single study visit (Day 1)
Sleep quality questionnaire
The Pediatric Sleep Questionnaire will be administered to parents. Items are answered "yes", "no", or "I don't know", and higher scores indicate more signs of obstructive sleep-disordered breathing.
Measured: At enrollment, during the single study visit (Day 1)
Sleep-related quality of life questionnaire
The Obstructive Sleep Apnea-18 (OSA-18) questionnaire will be administered to parents. Higher scores indicate a greater impact of sleep-disordered breathing on quality of life.
Measured: At enrollment, during the single study visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Oct 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Jan 2029 (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.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- CHC MontLégia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861230
- Sponsor's protocol ID
- TMAC-C2
- Status last verified
- Nov 2026
- First submitted
- 24 Sep 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- 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 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
- ClinicalTrials.gov ID
- NCT07861230
- Acronym / sponsor ID
- TMAC-C2
- Conditions
- Obstructive Sleep Disordered Breathing
- Keywords
- obstructive sleep disordered breathing, children, sleep apnea, tongue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- CHC MontLégia
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 6 Oct 2026 (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 tongue plays a key role in maintaining upper airway patency during sleep, mainly through the genioglossus, the principal pharyngeal dilator muscle. Its dysfunction may be linked to the development of obstructive sleep-disordered breathing (oSDB), a condition affecting more than one in ten children and associated with cardiovascular and cognitive consequences. Although adenotonsillectomy remains the treatment of choice, it fails in a substantial proportion of cases because of persistent obstruction at other sites, the tongue base being involved in one third of these cases. Therefore, a better characterization of the tongue in children with oSDB is needed, since the extent to which its structure and function contribute to upper airway obstruction in this population remains largely unknown.
Our team has established the reproducibility of tongue function measurements in healthy children and is currently building a reference database. What is still lacking is an assessment of tongue structure and function in children with oSDB. Such data would allow comparison with healthy children, thereby improving the understanding of oSDB pathophysiology and informing clinical management.
Primary objective: To describe tongue structure and function in children with oSDB.
Secondary objective: To compare tongue structure and function between children with oSDB and healthy children, using data from a previous study conducted in healthy children (TMAC study, UCLouvain).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unique arm, cross-sectional assessment | – | Other: Cross-sectional assessmentSingle assessment visit |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with obstructive sleep-disordered breathing, with a scheduled polysomnography or who received a polysomnography within the past 6 months, and without any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III
Key inclusion criteria (3 listed)
- Aged 4 to 17 years
- Scheduled polysomnography, or polysomnography performed within the past 6 months
- Positive Pediatric Sleep Questionnaire (8 "yes" answers or more)
Key exclusion criteria (2 listed)
- Any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III
- Any condition that could interfere with the assessments
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 |
|---|---|---|
| Cross-sectional assessmentThis cross-sectional assessment includes outcomes related to tongue structure, tongue function, and questionnaires | Other | Unique arm, cross-sectional assessment |
Primary outcome
Tongue strength assessment
Time frame: At enrollment, during the single study visit (Day 1)
Maximal pressure exerted by the tongue against an air-filled bulb (in kPa) in protrusion, elevation, and during swallowing.
8 secondary outcomes
Tongue morphology assessment
Time frame: At enrollment, during the single study visit (Day 1)
Tongue frenulum assessment
Time frame: At enrollment, during the single study visit (Day 1)
Tongue mobility score
Time frame: At enrollment, during the single study visit (Day 1)
Obstructive apnea-hypopnea index
Time frame: At enrollment, during the single study visit (Day 1)
Breathing pattern questionnaire
Time frame: At enrollment, during the single study visit (Day 1)
Quality of life questionnaire
Time frame: At enrollment, during the single study visit (Day 1)
Sleep quality questionnaire
Time frame: At enrollment, during the single study visit (Day 1)
Sleep-related quality of life questionnaire
Time frame: At enrollment, during the single study visit (Day 1)
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 Nov 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.
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 3 inclusion and 2 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 Nov 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, Professor (0471 90 66 23, william.poncin@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tongue strength assessment (time frame: At enrollment, during the single study visit (Day 1)). 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 Nov 2026.