Tongue Motor Functions Assessment as a Screening Tool for Obstructive Sleep Disordered Breathing in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Extent of tongue base obstruction
研究概览
简要总结
This study investigates the hypothesis that, in children, tongue motor functions can predict both the anatomical site and the degree of upper airway obstruction contributing to obstructive sleep-disordered breathing.
详细描述
Patients will be enrolled during their visit to the ENT physician. Subsequently, their tongue motor functions will be assessed during their pre-surgical appointment. Finally, they will undergo a drug-induced sleep endoscopy prior to their surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 and 17 years old
- •Medical diagnosis of obstructive sleep-disordered breathing requiring surgical removal of tonsils (partial or total) and/or adenoids
- •Positive Pediatric Sleep Questionnaire (8 or more positive responses)
- •Eligibility for surgical intervention
排除标准
- •Neurological, cardiac, or respiratory comorbidity other than obstructive sleep-disordered breathing
- •Previous surgery of the upper airway or oral cavity
- •History of or current head or neck cancer
- •Cranial, upper airway, or oral cavity malformation
- •Contraindication to performing endoscopy
研究组 & 干预措施
Children with obstructive sleep disordered breathing
干预措施: Drug-Induced Sleep Endoscopy (Diagnostic Test)
Children with obstructive sleep disordered breathing
干预措施: Physiotherapist assessment (Other)
Children with obstructive sleep disordered breathing
干预措施: ENT assessment (Other)
结局指标
主要结局
Extent of tongue base obstruction
时间窗: During the planned surgery
Evaluated through the IPSES scoring during a Drug Induced Sleep Endoscopy (DISE)
次要结局
- Breathing pattern(During the pre-surgical appointment)
- Tongue mobility (MBLF score)(During the pre-surgical appointment)
- Tongue pressures (kPa)(During the pre-surgical appointment)
- Tongue mobility restriction due to its frenulum ratio (%)(During the pre-surgical appointment)
研究者
William Poncin
Principal Investigator, Professor
Université Catholique de Louvain