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临床试验/NCT01676181
NCT01676181已完成不适用

Randomised Surgical Intervention Study Between Adenotonsillectomy and Adenotonsillotomy in Children With Obstructive Sleep Apnea Syndrome

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
79
试验地点
2
主要终点
Changes in polysomnographic parameter AHI (Apnea Hypopnea Index)

研究概览

简要总结

Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.

详细描述

Background: Children with obstructive sleep apnea syndrome (OSAS) have apneas and disturbed sleep, which causes daytime symptoms such as neurobehavioral problems. OSAS is a significant cause of morbidity among children with an incidence of 1-3%, and a peak prevalence at 2-5 years of age. If left untreated it can cause severe complications including failure to thrive, cardiovascular complications, metabolic conditions and neurobehavioral disturbances (eg hyperactivity, inattention).

Golden standard to diagnose OSA in children is full-night polysomnography (PSG) at a sleep laboratory including EEG, EOG, EMG, video-audiometry and respiratory recordings. At the Department of Otorhinolaryngology at Karolinska University Hospital, we have a sleep laboratory performing in-lab full-night polysomnography.

The cause of OSAS in children is usually adenotonsillar hypertrophy, and the treatment of choice is surgical removal of tonsils and adenoid. Traditionally total adenotonsillectomy (ATE) has been performed, but in the last decade an alternative surgical method with partial adenotonsillotomy (ATT) is developed, where only the medial portion of the tonsil is removed. The newer method ATT is not fully evaluated in comparison with traditional ATE. There are studies comparing evaluating post-operative pain and bleeding showing a slight advantage for the TT-method. Very few studies are performed using objectively measured PSG-parameters to evaluate the effect of surgery on the sleep fragmentation and the sleep apneas. There is a need for such studies in the field of surgical treatment of pediatric OSA. This was also stated in a Cochrane database review from 2009, in which the conclusion was that there is a need for high quality randomised controlled trials to be carried out investigating the efficacy of surgical treatment of OSA in children. This makes this study important and of high clinical interest.

Aims: To increase the knowledge of pediatric OSA and its treatment and to optimize the surgical treatment for children with OSA.

To through a blinded randomized controlled trial compare the efficacy of ATT and ATE in treating OSA in children, including long-term follow-up after one, three and ten years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 2-6 years
  • Clinical symptoms of OSAS (apneas, snoring, disturbed sleep)
  • Tonsil size 3-4 with the Brodsky scale (obstructing at least 50% of the oro-pharyngeal space)
  • Apnea-Hypopnea Index (AHI) 5-30 (moderate- severe OSA)

排除标准

  • Clinical signs of craniofacial anomalies or neuromuscular disorders
  • Earlier having had surgery of tonsils or adenoid
  • Bleeding disorder
  • Cardiopulmonary disorder

结局指标

主要结局

Changes in polysomnographic parameter AHI (Apnea Hypopnea Index)

时间窗: One, three and ten years

AHI; the number of apneas and hypopneas per sleep hour, is measured through polysomnography before and after surgery.

次要结局

  • Changes in quality of life questionnaires (OSA18 and SDQ)(One, three and ten Years)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Danielle Friberg

Associate Professor, senior surgeon

Karolinska University Hospital

研究点 (2)

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