Tongue Muscular Assessment in Children With Sleep Disordered Breathing (TMAC-C)

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia FRANCO, MD, PhD; Phone Number: +33 4 27 85 60 52; Email: patricia.franco@chu-lyon.fr
• Study Contact Backup: Name: Aurore GUYON, PhD; Phone Number: +33 4 27 85 52; Email: aurore.guyon@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
    • Contact: Aurore GUYON, PHD; Phone Number: +33 4 27 85 52 47; Email: aurore.guyon@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 respiratory conditions other than sleep disorders and their repercussions
  • Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)
  • Previous surgery performed on the upper airway or the oral cavity
  • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Children referred for polysomnography for suspected OSA; Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA

Other: Tongue Strength Assessment; 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; Diagnostic test: Polysomnography; 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.; Other: Subjective Assessment of Sleep-Disordered Breathing; 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; Other: Subjective Assessment of Daytime Functioning; The following questionnaires will be filled out: Epworth Sleepiness Scale; Conners; Other: Anthropometry; The following measures will be collected via the Quick Tongue-Tie Assessment tool: Maximal mouth opening; Maximal mouth opening with tongue to palate; Other: Clinical Examination; The following variables will be collected during a clinical examination: Age; Sex; Weight; Height; BMI; Friedman score; Mallampati score; Medical history; Other: Orofacial Praxis Assessment; Bucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Day 1
Obstructive apnea-hypopnea index (OAHI)	Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.	Day 1
Central apnea-hypopnea index	Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.	Day 1
Mixed apnea-hypopnea index	Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.	Day 1
Respiratory effort index	Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.	Day 1
Respiratory effort-related arousal index (RERA)	Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.	Day 1
Mean CO2	Respiratory parameters will be assessed by night polysomnography.	Day 1
Max CO2	Respiratory parameters will be assessed by night polysomnography.	Day 1
Time spent with CO2 > 50mmHg	Respiratory parameters will be assessed by night polysomnography.	Day 1
Mean SpO2	Respiratory parameters will be assessed by night polysomnography.	Day 1
Desaturation index ≥ 3%	Respiratory parameters will be assessed by night polysomnography.	Day 1
Desaturation index ≥ 4%	Respiratory parameters will be assessed by night polysomnography.	Day 1
Time spent with SaO2 < 90%	Respiratory parameters will be assessed by night polysomnography.	Day 1
Total sleep time	Sleep architecture parameters will be assessed by night polysomnography.	Day 1
Sleep onset latency	Sleep architecture parameters will be assessed by night polysomnography.	Day 1
Wake after sleep onset	Sleep architecture parameters will be assessed by night polysomnography.	Day 1
Duration of sleep N1	Sleep architecture parameters will be assessed by night polysomnography.	Day 1
Duration of sleep N2	Sleep architecture parameters will be assessed by night polysomnography.	Day 1
Duration of sleep N3	Sleep architecture parameters will be assessed by night polysomnography.	Day 1
Duration of REM sleep	Sleep architecture parameters will be assessed by night polysomnography.	Day 1
Sleep efficiency	Sleep architecture parameters will be assessed by night polysomnography.	Day 1
Score on Abreu's Questionnaire	Total score ranges from 0 to 16. Higher scores indicate a worse outcome.	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.	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.	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.	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.	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.	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.	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).	Day 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2026
• Primary Completion (Estimated): September 26, 2027
• Study Completion (Estimated): September 26, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Sleep; Tongue; Motor functions; Sleep apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Investigative Techniques; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Public Health; Environment and Public Health; Epidemiologic Measurements; Behavior Control; Immobilization; Physical Examination; Monitoring, Physiologic; Biometry; Restraint, Physical; Polysomnography; Anthropometry
• Other Study ID Numbers: 69HCL25_0288; 2025-A01527-42 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No