Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07273019

Tongue Muscular Assessment in Children With Sleep Disordered Breathing

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant

Bron, 69500, France

Location status: Recruiting

Location contact

Aurore GUYON, PhD

CONTACT

[email protected]

+33 4 27 85 52 47

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • With suspected sleep-disordered breathing
  • Referred for polysomnography
  • Affiliated to a social security scheme
  • With informed consent from both legal representatives

Exclusion criteria

  • 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

Treatment and study plan

Tongue strength assessment

Other

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

Polysomnography

Diagnostic 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 Breathing

Other

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 Functioning

Other

The following questionnaires will be filled out:

  • Epworth Sleepiness Scale
  • Conners

Anthropometry

Other

The following measures will be collected via the Quick Tongue-Tie Assessment tool:

  • Maximal mouth opening
  • Maximal mouth opening with tongue to palate

Clinical examination

Other

The following variables will be collected during a clinical examination:

  • Age
  • Sex
  • Weight
  • Height
  • BMI
  • Friedman score
  • Mallampati score
  • Medical history

Orofacial praxis assessment

Other

Bucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Tongue peak pressure during elevation and swallowing

    Time frame: Day 1

    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.

  2. Tongue mobility restriction

    Time frame: Day 1

    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.

  3. Orofacial praxis

    Time frame: Day 1

    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.

  4. Obstructive apnea-hypopnea index (OAHI)

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.

  5. Central apnea-hypopnea index

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.

  6. Mixed apnea-hypopnea index

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.

  7. Respiratory effort index

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.

  8. Respiratory effort-related arousal index (RERA)

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.

  9. Mean CO2

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography.

  10. Max CO2

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography.

  11. Time spent with CO2 > 50mmHg

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography.

  12. Mean SpO2

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography.

  13. Desaturation index ≥ 3%

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography.

  14. Desaturation index ≥ 4%

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography.

  15. Time spent with SaO2 < 90%

    Time frame: Day 1

    Respiratory parameters will be assessed by night polysomnography.

  16. Total sleep time

    Time frame: Day 1

    Sleep architecture parameters will be assessed by night polysomnography.

  17. Sleep onset latency

    Time frame: Day 1

    Sleep architecture parameters will be assessed by night polysomnography.

  18. Wake after sleep onset

    Time frame: Day 1

    Sleep architecture parameters will be assessed by night polysomnography.

  19. Duration of sleep N1

    Time frame: Day 1

    Sleep architecture parameters will be assessed by night polysomnography.

  20. Duration of sleep N2

    Time frame: Day 1

    Sleep architecture parameters will be assessed by night polysomnography.

  21. Duration of sleep N3

    Time frame: Day 1

    Sleep architecture parameters will be assessed by night polysomnography.

  22. Duration of REM sleep

    Time frame: Day 1

    Sleep architecture parameters will be assessed by night polysomnography.

  23. Sleep efficiency

    Time frame: Day 1

    Sleep architecture parameters will be assessed by night polysomnography.

  24. Score on Abreu's Questionnaire

    Time frame: Day 1

    Total score ranges from 0 to 16. Higher scores indicate a worse outcome.

  25. Score on the OSA-18 Questionnaire

    Time frame: Day 1

    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.

  26. Score on the Pediatric Sleep Questionnaire

    Time frame: Day 1

    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.

  27. Score on the Spruyt & Gozal Questionnaire

    Time frame: Day 1

    This questionnaire assesses sleep-disordered breathing in children. Total score ranges from 0 to 4. Higher scores indicate a worse outcome.

  28. Score on the Sleep Disturbance Scale for Children

    Time frame: Day 1

    This questionnaire assesses sleep disturbance in children. Total score ranges from 25 to 125. Higher scores indicate a worse outcome.

  29. Score on the French Version of the Sleepiness Scale for Adolescents

    Time frame: Day 1

    This questionnaire assesses excessive daytime sleepiness. Total score ranges from 25 to 125. Higher scores indicate a worse outcome.

  30. Score on the Conners Rating Scale

    Time frame: Day 1

    This questionnaire assesses hyperactivity. Total score ranges from 0 to 30. Higher scores indicate a worse outcome.

  31. Medical history

    Time frame: Day 1

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore GUYON, PhD

CONTACT

[email protected]

+33 4 27 85 52

Patricia FRANCO, MD, PhD

CONTACT

[email protected]

+33 4 27 85 60 52

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Tongue Muscular Assessment in Children Referred for Polysomnography in a Context of Suspected Obstructive Sleep Apnea

Acronym: TMAC-C

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 9, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.