Long-term Evaluation of Nasopharyngeal Airway in Hypotonia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnography
研究概览
简要总结
This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with Hypotonic Upper Airway Obstruction (HUAO) that took part in the original study (HUM00189669/NCT04846400 or HUM00220966/NCT05527652 trials)
- •Willingness to continue device usage.
- •Confirmed diagnosis of OSA (apnea/hypopnea index; AHI > 10 or AHI >5 with lowest oxygen level ≤75%)
- •At least one symptom of OSA (such as frequent snoring, daytime sleepiness, or hyperactive/inattentive behaviors)
- •Previous adenotonsillectomy (unless tonsillectomy not possible)
- •Tonsil size 2+ or smaller
排除标准
- •Participants that were non-compliant with the Self-Supporting Nasopharyngeal Airway (ssNPA) device during participation in the parent study listed above
- •Any medical reason why ssNPA therapy may not be suitable
- •Active COVID 19 infections Moderate/severe tracheobronchomalacia
- •Need for anticoagulative therapy
- •Bleeding disorder
- •Restrictive thoracic disorders
结局指标
主要结局
Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnography
时间窗: Approximately 1 year
Device efficacy will be measured by apnea/hypopnea index.
Long term device tolerability assessed by self-report from caregivers
时间窗: 2 years
This is a one question (likert scale 1-10) that participants\' caregivers will complete at the final assessment (higher scores indicating better device tolerability).
次要结局
- Long-term impact on sleep quality will be assessed by the mean score on the parent report of sleep quality(1-2 years)
- Long-term impact on daytime sleepiness will be assessed by the mean score on the children's Epworth Sleepiness Scale (ESS)(1-2 years)
- Long-term impact on quality of life will be assessed with the OSA-18(1-2 years)
- Family Impact Questionnaire (FIQ)(1-2 years)
研究者
Louise O'Brien
Professor
University of Michigan