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临床试验/NCT05459935
NCT05459935招募中不适用

Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation

University of Alberta2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年10月15日最近更新:
适应症
干预措施

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

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

Experimental

Photobiomodulation exposure of hypertrophic tonsils

干预措施: PBM Tonsil Arm (Device)

Tonsil Control Arm

Sham Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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