Tongue Muscular Assessment in Children With Sleep Disordered Breathing

Официальное название

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

Обзор

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.

Вмешательства

• Другое Tongue Strength Assessment
  The 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
• Диагностический тест 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.
• Другое 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
• Другое Subjective Assessment of Daytime Functioning
  The following questionnaires will be filled out: * Epworth Sleepiness Scale * Conners
• Другое Anthropometry
  The following measures will be collected via the Quick Tongue-Tie Assessment tool: 1. Maximal mouth opening 2. Maximal mouth opening with tongue to palate
• Другое Clinical Examination
  The 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
• Другое Orofacial Praxis Assessment
  Bucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF).

Первичные конечные точки

• Tongue peak pressure during protrusion [Срок оценки: Day 1]

Вторичные конечные точки (12)

• Tongue peak pressure during elevation and swallowing [Срок оценки: Day 1]
• Tongue mobility restriction [Срок оценки: Day 1]
• Orofacial praxis [Срок оценки: Day 1]
• Obstructive apnea-hypopnea index (OAHI) [Срок оценки: Day 1]
• Central apnea-hypopnea index [Срок оценки: Day 1]
• Mixed apnea-hypopnea index [Срок оценки: Day 1]
• Respiratory effort index [Срок оценки: Day 1]
• Respiratory effort-related arousal index (RERA) [Срок оценки: Day 1]
• Mean CO2 [Срок оценки: Day 1]
• Max CO2 [Срок оценки: Day 1]
• Time spent with CO2 > 50mmHg [Срок оценки: Day 1]
• Mean SpO2 [Срок оценки: Day 1]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et d — Bron

Идентификаторы

NCT: NCT07273019 · 69HCL25_0288 · 2025-A01527-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗