跳至主要内容
临床试验/NCT07195253
NCT07195253招募中不适用

Exploring the Relationships Between Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Number of peaks composing sucking bursts and obstructive apnea-hypopnea index (OAHI).

研究概览

简要总结

Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals. In children, OSA can have long-term consequences on the development and on the cardiovascular system.

Down Syndrome (DS) is a genetic disorder associated with intellectual disability and many comorbidities. The prevalence of OSA is particularly high in patients with DS, from infancy. In a recent study by Fauroux et al. (2024), OSA was diagnosed in 97% infants and early diagnosis and intervention from the age of 6 months was associated with better neurocognitive outcome at 3 years old. However, polysomnography (PSG - the gold standard method for diagnosing OSA) is poorly accessible, highlighting the need to develop new strategies to prevent and to screen OSA early in infancy.

OSA can be linked to some orofacial abnormalities presented by patients with DS. Indeed, orofacial functions and structures ca play a crucial role in OSA. For example, nose breathing allows the tongue to act as a stimulator of the transverse maxillary growth during childhood, allowing the upper airway to develop properly.

The primary objective of the present study is to explore the relationships between oro-myo-facial functions, more specifically non-nutritive sucking, and the severity of OSA in 6 months old infants with DS.

The main hypothesis is that OSA severity (estimated by the obstructive apnea hypopnea index on PSG) will be negatively correlated to non-nutritive sucking performance.

Data from this study could help developing easily accessible protocols for OSA screening based on simple sucking recording. Some interventions could also be tested to prevent OSA from the beginning of life, like an innovative pacifier recently developed by a French start-up to stimulate nose breathing and to promote correct positioning of the tongue.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Months 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • (infants with Down Syndrome)
  • Aged 6 months (±3 weeks)
  • Diagnosed with Trisomy 21
  • Affiliated to a social security scheme
  • With informed consent of the 2 legal representatives

排除标准

  • Diagnosed with mosaic Down syndrome
  • Born preterm (gestation age at birth <37 weeks)
  • Treated for OSA with Continuous Positive Airway Pressure
  • Known allergy to silicone
  • Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies
  • Refusal from legal representatives.

研究组 & 干预措施

Infants with Down Syndrome

6 month-old infants with Down Syndrome recorded by polysomnography

干预措施: Polysomnography (PSG) to explore OSA (Diagnostic Test)

Infants with Down Syndrome

6 month-old infants with Down Syndrome recorded by polysomnography

干预措施: Oro-myo-functional clinical evaluation (Other)

Infants with Down Syndrome

6 month-old infants with Down Syndrome recorded by polysomnography

干预措施: Sleep Disturbance Scale for Children (Other)

Infants with Down Syndrome

6 month-old infants with Down Syndrome recorded by polysomnography

干预措施: Non-nutritive sucking recording (Other)

Infants with Down Syndrome

6 month-old infants with Down Syndrome recorded by polysomnography

干预措施: Neurocognitive evaluation (Behavioral)

Infants with Down Syndrome

6 month-old infants with Down Syndrome recorded by polysomnography

干预措施: PedsQL-Infants (Other)

Infants with Down Syndrome

6 month-old infants with Down Syndrome recorded by polysomnography

干预措施: Sleep Hygiene Scale for Children (Other)

结局指标

主要结局

Number of peaks composing sucking bursts and obstructive apnea-hypopnea index (OAHI).

时间窗: Day 1

Number of peaks during sucking bursts will be measured by non-nutritive sucking recording. OAHI will be measured by PSG.

Number of peaks composing sucking bursts and obstructive apnea-hypopnea index (OAHI)

时间窗: Day 1

Number of peaks during sucking bursts will be measured by non-nutritive sucking recording. OAHI will be measured by PSG.

次要结局

  • Electrophysiological evaluation of sucking(Day 1)
  • Respiratory PSG indices(Night between Day 1 and Day 2.)
  • Heart rate variability (HRV)(Night between Day 1 and Day 2.)
  • Neuropsychological evaluation.(Day 2)
  • Clinical examination of oro-facial myo-functional characteristics(Day 2)
  • PSG sleep architecture parameters(Night between Day 1 and Day 2.)
  • Oro-facial myo-functional characteristics(D1)
  • Subjective parental evaluation of sleep disorders on the Sleep Disturbance Scale for Children (SDSC)(Day 1)
  • Subjective parental evaluation of sleep hygiene on the Sleep Hygiene Scale for Children (SHSC)(Day 1)
  • Neuropsychological evaluation(Day 2)
  • Quality of life on the PedsQL(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验