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

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Other: Anthropometry; Diagnostic Test: Polysomnography; Other: Subjective Assessment of Sleep-Disordered Breathing; Other: Subjective Assessment of Daytime Functioning; Other: Clinical Examination; Other: Tongue Strength Assessment; Other: Orofacial Praxis Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT07273019

2025-A01527-42 (Other Identifier)

69HCL25_0288

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Children referred for polysomnography for suspected OSA

Experimental group

Description:

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

Treatment:

Other: Orofacial Praxis Assessment

Other: Tongue Strength Assessment

Other: Clinical Examination

Other: Subjective Assessment of Daytime Functioning

Other: Subjective Assessment of Sleep-Disordered Breathing

Diagnostic Test: Polysomnography

Other: Anthropometry