Obstructive Sleep ApneaTMAC-CNCT07273019
Tongue Muscular Assessment in Children With Sleep Disordered Breathing
A study testing Tongue Strength Assessment, Polysomnography and Subjective Assessment of Sleep-Disordered Breathing in people with Obstructive Sleep Apnea, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Obstructive sleep apnea (OSA) is part of the sleep-disordered breathing spectrum. Its prevalence in children is 1-5%, and it can have negative consequences at the cardiovascular, cognitive as well as behavioral levels. In children, the first-line treatment is adenotonsillectomy. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Tongue Strength Assessment, Polysomnography and Subjective Assessment of Sleep-Disordered Breathing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2026to 26 Mar 2028
- Phase
- Interventional
- 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
Who may be able to join
- With suspected sleep-disordered breathing
- Referred for polysomnography
- Affiliated to a social security scheme
- With informed consent from both legal representatives
Who cannot join
- Insufficient comprehension of French language
- Regarding patients with suspected OSA type I or II:
- Neurological, cardiac, or unstable respiratory conditions other than sleep disorders and their repercussions
- Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)
- Malformation of the skull, the upper airway or the oral cavity
- Regarding patients with suspected OSA type III:
- Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)
- Intellectual deficit impeding the understanding of instructions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
Bron, 69500
Aurore GUYON, PhD, +33 4 27 85 52 47, aurore.guyon@chu-lyon.fr
About this study
Official title: Tongue Muscular Assessment in Children Referred for Polysomnography in a Context of Suspected Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) is part of the sleep-disordered breathing spectrum. Its prevalence in children is 1-5%, and it can have negative consequences at the cardiovascular, cognitive as well as behavioral levels. In children, the first-line treatment is adenotonsillectomy. However, residual obstructive events can persist as the success rate of surgery reaches only 49% in non-obese children. Residual OSA may be explained by multiple sites of obstruction, found in 20-85% children concerned by persistent OSA. Indeed, the tongue appears among one possible primary sites of obstruction. Given the tongue's crucial role in upper-airway patency during sleep, its assessment can inform us about the myofunctional deficits involved in sleep-disordered breathing.
The primary objective of the present study is to assess tongue motor functions in children with sleep-disordered breathing and to compare them to those of healthy children (data collected in a current study (TMAC) conducted at UCLouvain, Belgium; NCT06166680), in order to document possible myofunctional deficits in children with OSA. The hypothesis is that tongue motor functions will be lower in children with sleep-disordered breathing.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Tongue Strength Assessment, Polysomnography, Subjective Assessment of Sleep-Disordered Breathing, Subjective Assessment of Daytime Functioning, Anthropometry
- Keywords
- Tongue, Motor functions, Sleep, Sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue Strength AssessmentOther
The following items will be assessed:
- Tongue peak pressure during 3 seconds of tongue protrusion
- Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 seconds of tongue elevation
- Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing
PolysomnographyDiagnostic test
Patients will undergo full-night polysomnography (including the JAWAC system to record mandibular movements) in the sleep unit of Hôpital Femme-Mère-Enfant (Bron, France) to explore OSA.
Subjective Assessment of Sleep-Disordered BreathingOther
The following questionnaires will be filled out:
- OSA-18
- Pediatric Sleep Questionnaire (PSQ)
- Spruyt \& Gozal
- Sleep Disturbance Scale for Children
- Abreu et al.'s questionnaire
Subjective Assessment of Daytime FunctioningOther
The following questionnaires will be filled out:
- Epworth Sleepiness Scale
- Conners
AnthropometryOther
The following measures will be collected via the Quick Tongue-Tie Assessment tool:
- Maximal mouth opening
- Maximal mouth opening with tongue to palate
Clinical ExaminationOther
The following variables will be collected during a clinical examination:
- Age
- Sex
- Weight
- Height
- BMI
- Friedman score
- Mallampati score
- Medical history
Orofacial Praxis AssessmentOther
Bucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF).
| Study group | Role | What they receive |
|---|---|---|
| Children referred for polysomnography for suspected OSA | Experimental | Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA Receives: Other: Tongue Strength Assessment; Diagnostic Test: Polysomnography; Other: Subjective Assessment of Sleep-Disordered Breathing; Other: Subjective Assessment of Daytime Functioning; Other: Anthropometry; Other: Clinical Examination; Other: Orofacial Praxis Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue peak pressure during protrusion
Tongue peak pressure during protrusion will be measured using the IOPI (Iowa Oral Performance Instrument) device. Higher tongue pressure is considered a better outcome.
Measured: Day 1
Secondary outcomes (31)
Tongue peak pressure during elevation and swallowing
Tongue peak pressure during elevation and swallowing movements will be measured using the IOPI (Iowa Oral Performance Instrument) device. Higher tongue pressure is considered a better outcome.
Measured: Day 1
Tongue mobility restriction
Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate, measured using the Quick Tongue-Tie Assessment tool. Higher values are considered a better outcome.
Measured: Day 1
Orofacial praxis
Orofacial praxis will be assessed through the Motricité Bucco-Linguo-Faciale (MBLF) test, which ranges from 0 to 111. Higher scores indicate a better outcome.
Measured: Day 1
Obstructive apnea-hypopnea index (OAHI)
Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.
Measured: Day 1
Central apnea-hypopnea index
Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.
Measured: Day 1
Mixed apnea-hypopnea index
Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.
Measured: Day 1
Respiratory effort index
Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.
Measured: Day 1
Respiratory effort-related arousal index (RERA)
Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.
Measured: Day 1
Mean CO2
Respiratory parameters will be assessed by night polysomnography.
Measured: Day 1
Max CO2
Respiratory parameters will be assessed by night polysomnography.
Measured: Day 1
Time spent with CO2 > 50mmHg
Respiratory parameters will be assessed by night polysomnography.
Measured: Day 1
Mean SpO2
Respiratory parameters will be assessed by night polysomnography.
Measured: Day 1
Desaturation index ≥ 3%
Respiratory parameters will be assessed by night polysomnography.
Measured: Day 1
Desaturation index ≥ 4%
Respiratory parameters will be assessed by night polysomnography.
Measured: Day 1
Time spent with SaO2 < 90%
Respiratory parameters will be assessed by night polysomnography.
Measured: Day 1
Total sleep time
Sleep architecture parameters will be assessed by night polysomnography.
Measured: Day 1
Sleep onset latency
Sleep architecture parameters will be assessed by night polysomnography.
Measured: Day 1
Wake after sleep onset
Sleep architecture parameters will be assessed by night polysomnography.
Measured: Day 1
Duration of sleep N1
Sleep architecture parameters will be assessed by night polysomnography.
Measured: Day 1
Duration of sleep N2
Sleep architecture parameters will be assessed by night polysomnography.
Measured: Day 1
Duration of sleep N3
Sleep architecture parameters will be assessed by night polysomnography.
Measured: Day 1
Duration of REM sleep
Sleep architecture parameters will be assessed by night polysomnography.
Measured: Day 1
Sleep efficiency
Sleep architecture parameters will be assessed by night polysomnography.
Measured: Day 1
Score on Abreu's Questionnaire
Total score ranges from 0 to 16. Higher scores indicate a worse outcome.
Measured: Day 1
Score on the OSA-18 Questionnaire
This questionnaire assesses quality of life associated with sleep-disordered breathing in children. Total score ranges from 18 to 126. Higher scores indicate a worse outcome.
Measured: Day 1
Score on the Pediatric Sleep Questionnaire
This questionnaire assesses symptoms and repercussions of sleep-disordered breathing in children. Total score ranges from 0 to 22. Higher scores indicate a worse outcome.
Measured: Day 1
Score on the Spruyt & Gozal Questionnaire
This questionnaire assesses sleep-disordered breathing in children. Total score ranges from 0 to 4. Higher scores indicate a worse outcome.
Measured: Day 1
Score on the Sleep Disturbance Scale for Children
This questionnaire assesses sleep disturbance in children. Total score ranges from 25 to 125. Higher scores indicate a worse outcome.
Measured: Day 1
Score on the French Version of the Sleepiness Scale for Adolescents
This questionnaire assesses excessive daytime sleepiness. Total score ranges from 25 to 125. Higher scores indicate a worse outcome.
Measured: Day 1
Score on the Conners Rating Scale
This questionnaire assesses hyperactivity. Total score ranges from 0 to 30. Higher scores indicate a worse outcome.
Measured: Day 1
Medical history
Medical history is conducted by a doctor. It will be used to determine the type of OSA (craniofacial and/or syndromic comorbidities classify OSA as type III; otherwise, OSA is type II in the presence of obesity, or type I in the absence of obesity).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start26 Mar 2026
- Primary completion26 Mar 2028 (estimated)
- Study completion26 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Children (4-17 years old) referred to the sleep clinic for polysomnography in a context of suspected obstructive sleep apnea.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273019
- Sponsor's protocol ID
- 69HCL25_0288
- Other IDs
- 2025-A01527-42
- Acronym
- TMAC-C
- Status last verified
- Jul 2026
- First submitted
- 19 Nov 2025
- Last updated
- 30 Jul 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Muscular Assessment in Children Referred for Polysomnography in a Context of Suspected Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07273019
- Acronym / sponsor ID
- TMAC-C / 69HCL25_0288
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Tongue, Motor functions, Sleep, Sleep apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 26 Mar 2028 (estimated)
- Study completion
- 26 Mar 2028 (estimated)
- First posted
- 9 Dec 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.
Obstructive sleep apnea (OSA) is part of the sleep-disordered breathing spectrum. Its prevalence in children is 1-5%, and it can have negative consequences at the cardiovascular, cognitive as well as behavioral levels. In children, the first-line treatment is adenotonsillectomy. However, residual obstructive events can persist as the success rate of surgery reaches only 49% in non-obese children. Residual OSA may be explained by multiple sites of obstruction, found in 20-85% children concerned by persistent OSA. Indeed, the tongue appears among one possible primary sites of obstruction. Given the tongue's crucial role in upper-airway patency during sleep, its assessment can inform us about the myofunctional deficits involved in sleep-disordered breathing.
The primary objective of the present study is to assess tongue motor functions in children with sleep-disordered breathing and to compare them to those of healthy children (data collected in a current study (TMAC) conducted at UCLouvain, Belgium; NCT06166680), in order to document possible myofunctional deficits in children with OSA. The hypothesis is that tongue motor functions will be lower in children with sleep-disordered breathing.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Children (4-17 years old) referred to the sleep clinic for polysomnography in a context of suspected obstructive sleep apnea.
| Arm | Type | Receives |
|---|---|---|
| Children referred for polysomnography for suspected OSA | Experimental | Other: Tongue Strength Assessment, Diagnostic Test: Polysomnography, Other: Subjective Assessment of Sleep-Disordered Breathing, Other: Subjective Assessment of Daytime Functioning, Other: Anthropometry, Other: Clinical Examination, Other: Orofacial Praxis AssessmentChildren aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- With suspected sleep-disordered breathing
- Referred for polysomnography
- Affiliated to a social security scheme
- With informed consent from both legal representatives
Key exclusion criteria (8 listed)
- Insufficient comprehension of French language
- Regarding patients with suspected OSA type I or II:
- Regarding patients with suspected OSA type III:
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 |
|---|---|---|
| Tongue Strength AssessmentThe following items will be assessed: 1. Tongue peak pressure during 3 seconds of tongue protrusion 2. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 seconds of tongue elevation 3. Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing | Other | Children referred for polysomnography for suspected OSA |
| PolysomnographyPatients will undergo full-night polysomnography (including the JAWAC system to record mandibular movements) in the sleep unit of Hôpital Femme-Mère-Enfant (Bron, France) to explore OSA. | Diagnostic test | Children referred for polysomnography for suspected OSA |
| Subjective Assessment of Sleep-Disordered BreathingThe following questionnaires will be filled out: * OSA-18 * Pediatric Sleep Questionnaire (PSQ) * Spruyt \& Gozal * Sleep Disturbance Scale for Children * Abreu et al.'s questionnaire | Other | Children referred for polysomnography for suspected OSA |
| Subjective Assessment of Daytime FunctioningThe following questionnaires will be filled out: * Epworth Sleepiness Scale * Conners | Other | Children referred for polysomnography for suspected OSA |
| AnthropometryThe following measures will be collected via the Quick Tongue-Tie Assessment tool: 1. Maximal mouth opening 2. Maximal mouth opening with tongue to palate | Other | Children referred for polysomnography for suspected OSA |
| Clinical ExaminationThe following variables will be collected during a clinical examination: 1. Age 2. Sex 3. Weight 4. Height 5. BMI 6. Friedman score 7. Mallampati score 8. Medical history | Other | Children referred for polysomnography for suspected OSA |
| Orofacial Praxis AssessmentBucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF). | Other | Children referred for polysomnography for suspected OSA |
Primary outcome
Tongue peak pressure during protrusion
Time frame: Day 1
Tongue peak pressure during protrusion will be measured using the IOPI (Iowa Oral Performance Instrument) device. Higher tongue pressure is considered a better outcome.
31 secondary outcomes
Tongue peak pressure during elevation and swallowing
Time frame: Day 1
Tongue mobility restriction
Time frame: Day 1
Orofacial praxis
Time frame: Day 1
Obstructive apnea-hypopnea index (OAHI)
Time frame: Day 1
Central apnea-hypopnea index
Time frame: Day 1
Mixed apnea-hypopnea index
Time frame: Day 1
Respiratory effort index
Time frame: Day 1
Respiratory effort-related arousal index (RERA)
Time frame: Day 1
Mean CO2
Time frame: Day 1
Max CO2
Time frame: Day 1
Time spent with CO2 > 50mmHg
Time frame: Day 1
Mean SpO2
Time frame: Day 1
Desaturation index ≥ 3%
Time frame: Day 1
Desaturation index ≥ 4%
Time frame: Day 1
Time spent with SaO2 < 90%
Time frame: Day 1
Total sleep time
Time frame: Day 1
Sleep onset latency
Time frame: Day 1
Wake after sleep onset
Time frame: Day 1
Duration of sleep N1
Time frame: Day 1
Duration of sleep N2
Time frame: Day 1
Duration of sleep N3
Time frame: Day 1
Duration of REM sleep
Time frame: Day 1
Sleep efficiency
Time frame: Day 1
Score on Abreu's Questionnaire
Time frame: Day 1
Score on the OSA-18 Questionnaire
Time frame: Day 1
Score on the Pediatric Sleep Questionnaire
Time frame: Day 1
Score on the Spruyt & Gozal Questionnaire
Time frame: Day 1
Score on the Sleep Disturbance Scale for Children
Time frame: Day 1
Score on the French Version of the Sleepiness Scale for Adolescents
Time frame: Day 1
Score on the Conners Rating Scale
Time frame: Day 1
Medical history
Time frame: 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 30 Jul 2026.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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?
A study testing Tongue Strength Assessment, Polysomnography and Subjective Assessment of Sleep-Disordered Breathing in people with Obstructive Sleep Apnea, run by Hospices Civils de Lyon at 1 site in France.
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 8 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 30 Jul 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 France. 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 Patricia FRANCO, MD, PhD (+33 4 27 85 60 52, patricia.franco@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tongue peak pressure during protrusion (time frame: 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 30 Jul 2026.