Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Tonsil Size
研究概览
简要总结
Pediatric obstructive sleep apnea is a medical condition where a child has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which the primary treatment is usually a surgery targeted towards removing swollen tonsils and adenoids. However, surgical removal of tonsils and adenoids comes with its own risks of complications during and after surgery including secondary hemorrhage and long term increased risks for respiratory and infectious diseases. Perhaps more importantly, surgical removal of swollen tonsils and adenoids does not guarantee successful treatment of a child's obstructive sleep apnea.
The use of laser light therapy in a non-cutting manner (known as photobiomodulation and abbreviated as PBM) has been a relatively new development within medicine. Recently, dentists have begun to use PBM as a method to treat adult snoring and, with lesser success, adult obstructive sleep apnea. To date, there are no known side effects to the use of PBM for the treatment of any sleep breathing disorders. However, no research has been published on the use of PBM for the treatment of pediatric obstructive sleep apnea or swollen tonsils in children
The purpose of this project is to determine whether photobiomodulation can provide a beneficial effect on pediatric hypertrophic tonsils and pediatric obstructive sleep apnea and, if it does, to create the appropriate workflow, referral pathways, and treatment parameters for clinicians to provide this treatment as a multidisciplinary approach in a clinical setting.
The investigators hypothesize that photobiomodulation can be used successfully to decrease the pediatric hypertrophic tonsils in children with symptoms of an pediatric obstructive sleep apnea and will also result in improved AHI scores (be able to breath significantly better when sleeping) in these children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Sham intervention (nonactivated/unpowered phototherapy intervention)
入排标准
- 年龄范围
- 6 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Brodsky visually graded tonsils 3/4
- •patient must assent, parent must consent, to all pre and post follow up including sleep testing
- •patient and parent must agree to normal referral protocols regardless of participation within this study or not
排除标准
- •visual indication of cancerous growth
- •currently under treatment (pharmacologic, other) for hypertrophic tonsils
- •already scheduled for surgical intervention of hypertrophic tonsils
研究组 & 干预措施
PBM Tonsil Arm
Photobiomodulation exposure of hypertrophic tonsils
干预措施: PBM Tonsil Arm (Device)
Tonsil Control Arm
Sham (non-powered) exposure of hypertrophic tonsils
干预措施: Sham PBM Tonsil Arm (Device)
结局指标
主要结局
Tonsil Size
时间窗: immediately after intervention
Tonsil size grading (Brodsky score): 0-4, 0 being not present 4 being restrictive to entire airway. Lower scores are better. Each integer represents 25% obstruction of airway (0 being not visible, 1 being 0-25%, 2 being 25-50%, 3 being 50-75%, 4 being 75-100%). There is no abbreviated scale title.
次要结局
- AHI Score(Next Day (next night))
- Questionnaire Improvement(night after, per quarter after for 1 year)
