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临床试验/NCT01837914
NCT01837914已完成不适用

Maxillary Expansion Treatment of Pediatric Obstructive Sleep Apnea

University of British Columbia2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
apnea-hypopnea index

研究概览

简要总结

Obstructive Sleep Apnea is a serious medical condition affecting an estimated 1-5% of children. The disease is believed to have several overlapping causes including large tonsils and small or narrow jaws. This prospective, randomized cross-over study will evaluate the effectiveness of orthodontic treatment of narrow upper teeth and jaws compared to the current standard of care which is surgical removal of the adenoids and tonsils.

Patients will be evaluated by both an orthodontist and ENT physician, complete a series of questionnaires and undergo an overnight sleep study, both initially and after undergoing the randomized treatment. Patients who on reassessment have residual symptoms of sleep apnea will then be crossed over and receive the other form of treatment. The levels of improvement to both subjective (questionnaire) and objective (overnight sleep study) measures of sleep apnea will then be compared.

The null hypothesis is there is no significant difference in improvement between maxillary expansion and adenotonsillectomy in the objective and subjective outcome measures in children with mild to moderate obstructive sleep apnea.

详细描述

Background Literature Review Obstructive sleep apnea syndrome (OSAS) is a sleep disorder characterized by recurrent, partial or complete episodes of upper airway obstruction, commonly associated with intermittent hypoxemia and sleep fragmentation.1 The best data available from international studies reports a prevalence rate of 1.2-5.7% in children.2-4 The potential consequences of OSAS in children are serious and include failure to thrive5, attention deficit and hyperactivity disorder6, excessive daytime sleepiness7, and poor learning6. There is also significant concern about long-term cardio-pulmonary risks in these patients8. Not surprisingly, along with higher morbidity, children with OSAS also have higher use of health care services starting from the first year of life9.

OSAS is a multifactorial disease, with the primary cause in children thought to be hypertrophic tonsils and adenoids. However the persistence of OSAS following surgery to remove the tonsils and adenoids is not uncommon. Recent studies using a moderate cut-off apnoea-hyponea index (AHI) of greater than 5 events per hour in relatively low-risk populations, have demonstrated that 13%10 to 29%11 of children have residual OSAS following adenotonsillectomy (AT). Craniofacial form also clearly plays a role in pediatric OSAS as skeletal discrepancies such as transverse maxillary deficiency have been strongly associated with the disease12,13, and skeletal malocclusion has been found to be predictive of a higher AT failure rate14. While the precise nature of the contribution of craniofacial proportions to OSAS remains to be characterized, there is early evidence in the literature to support maxillary expansion (ME) as an alternative treatment to surgery. Results of OSAS treatment with ME have suggested that it may be effective in reducing sleep respiratory disturbances in patients with15 and without16 tonsillar hypertrophy. However, limitations existing in the study designs have left unanswered questions as to the role of ME in the treatment of children suffering from OSAS. Furthermore the studies have been limited to patient populations in Rome, Italy, and while anatomical factors are key determinants of the predisposition to airway collapse, their relative importance for OSAS risk likely varies between ethnicities.17 For this reason, further studies examining these effects on a diverse multicultural population such as that found in North America and in particular urban centers such as Vancouver, Canada are warranted to realize the potential of this novel form of OSAS treatment.

Study Purpose The purpose of this study is to explore the efficacy of maxillary expansion in the treatment of OSAS in children with tonsil and adenoid hypertrophy.

  1. Hypothesis The null hypothesis is there is no significant difference in improvement between maxillary expansion and adenotonsillectomy in the objective and subjective outcome measures in children with mild to moderate obstructive sleep apnea.

  2. Objectives 4.1: Aim 1- To validate the methodology. The methodology will be validated through conducting this pilot study and analyzing the preliminary data that are generated - if required, improvements in methodology design can be identified during this pilot study to assist in design modification before a larger multi-site study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 6.0 to 10.0 years at the time of screening;
  • Diagnosed with obstructive sleep apnea defined as AHI>2, confirmed on overnight, laboratory-based PSG;
  • Parental report of witnessed apneas or habitual snoring (on average more than 3 nights per week);
  • Deemed to be a candidate for ME by orthodontic evaluation;
  • Deemed to be a candidate for tonsillectomy and adenoidectomy by otolaryngologic evaluation.

排除标准

  • Severe OSA or significant hypoxemia in the presence of tonsillar or adenoid hypertrophy requiring surgical intervention defined as AHI>25 or SpO2 <90% for >2% sleep time.
  • An associated craniofacial syndrome or anomaly, including cleft lip and/or palate, or any anatomic or systemic condition that would otherwise exclude the patient from orthodontic treatment.
  • Recurrent tonsillitis that meets American Academy of Otolaryngology - Head and Neck Surgery clinical practice guidelines for surgery.
  • Extremely overweight defined as a body mass index z-score > 2.99 for age group and sex.
  • Severe health problems that could be exacerbated by delayed treatment for OSA, including: severe cardiopulmonary disorders (e.g., cystic fibrosis, congenital heart disease); sickle cell disease; poorly controlled asthma (with > 1 hospitalization in last year); epilepsy requiring medication; diabetes (type 1 or type 2) requiring medication; doctor-diagnosed heart disease; or a history of stage II hypertension (HTN) defined as > 99% percentile and/or requiring medication.
  • Psychiatric or behavioral disorders that would otherwise exclude the patient from receiving orthodontic treatment

结局指标

主要结局

apnea-hypopnea index

时间窗: 4 months after intervention

Polysomnography sleep test score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin Pliska

Assistant Professor

University of British Columbia

研究点 (2)

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