Endoscopic Classification of Airway Obstruction and Drug Induced Sleep Endoscopy-Guided Surgery in Children With Obstructive Sleep-Disordered Breathing.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Treatment Failure Rate
研究概览
简要总结
Pediatric obstructive sleep apnea (OSA) can lead to severe health issues if untreated. While polysomnography is the gold standard for diagnosis, current surgical treatment in Denmark relies on caregiver reports and clinical exams. Approximately 25% of patients have persistent symptoms post-surgery, indicating the need for better diagnostic and treatment options. Drug-Induced Sleep Endoscopy (DISE) allows dynamic upper airway visualization during mild sedation, aiding in treatment decisions. This research project aims to evaluate the impact of DISE-guided interventions on pediatric OSA outcomes and compare its effectiveness and cost/benefit with traditional diagnostic approaches.
详细描述
Background
1.1 Pediatric Obstructive Sleep Apnea
Pediatric OSA ranges from simple snoring to severe upper airway obstruction during sleep. Left untreated, it can lead to significant health issues, especially in children, impacting their cognitive development, learning, and social interactions.
1.2 Diagnostics and Surgical Strategies
Polysomnography (PSG) is the gold standard for diagnosing OSA. In Denmark, PSG isn't widely used due to equipment and setup constraints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgically naïve, otherwise healthy, non-syndromic children aged 2-12 years with suspected oSDB of any severity
- •One completed Pediatric Sleep Questionnaire - Sleep Related Breathing Disorder (PSQ)
- •Home Respiratory Polygraphy (HRP) and/or in-house Polysomnography (PSG) showing OSA according to the definition of AAO-HNSF
排除标准
- •Syndromes and congenital/acquired craniofacial abnormalities/malformations of the upper airways
- •Neurological conditions affecting upper airway muscle tone
- •Lower airway disease (tracheomalacia, asthma)
- •Previous surgery of the nose/pharynx/larynx
结局指标
主要结局
Treatment Failure Rate
时间窗: one year post surgery
Proportion of patients, who exhibit persistent OSA post-surgery in the DISE-guided surgery group compared to the non-DISE-guided surgery group (controls).
次要结局
- DISE findings(initial assessment and one year post surgery)
- Quality of Life (OSA-18)(initial assessment and one year post surgery)
- OSA (AHI)(initial assessment and one year post surgery)
- Sedation-related and surgical complications(initial assessment and one year post surgery)
研究者
Mascha Eva Hildebrandt
MD
Regional Hospital West Jutland