A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 453
- 试验地点
- 6
- 主要终点
- Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.
研究概览
简要总结
The purpose of this research is to determine the effect of adenotonsillectomy surgery (removal of tonsils and adenoids) on obstructive sleep apnea syndrome (OSAS) in children. OSAS can cause health problems including poor growth, high blood pressure, diabetes and behavioral and learning difficulties. Although adenotonsillectomy is the usual treatment for children with OSAS, it is not known with any certainty if the child's OSAS symptoms improve afterwards. This study will help determine if improvement occurs or if it does not. It will also look at whether certain groups, such as children who are overweight or of different ethnicities, are helped by the surgery.
详细描述
Because adenotonsillectomy is the usual treatment for OSAS, all children in the study will get surgery. However, in order to assess the extent to which adenotonsillectomy surgery improves breathing disturbances and sleep quality in children with OSAS, two groups will be studied. One group will get surgery early (one month after enrollment) and the other group will be re-evaluated for surgery within 7 months of enrollment.
Children in both groups will be closely monitored through the 7-8 month study period and sleep and health educational materials will be provided to assist in establishing healthy habits.
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
- Single (Investigator)
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 5.0 to 9.99 years at time of screening.
- •Diagnosed with Obstructive Sleep Apnea defined as: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 2, confirmed on nocturnal, laboratory-based PSG and Parental report of habitual snoring (on average occurring >3 nights per week).
- •Tonsillar hypertrophy ≥ 1 based on a standardized scale of 0-4: 0 = surgically absent, 1 = taking up < 25% of the airway, 2 = 25 - 50 % of the airway,3 = 50 - 75 % of the airway, 4 = > 75% of the airway
- •Deemed to be a surgical candidate for AT by Ear, Nose and Throat specialist (ENT) evaluation.
排除标准
- •Recurrent tonsillitis defined as: >3 episodes in each of 3 years, 5 episodes in each of 2 years, or 7 episodes in one year
- •Craniofacial anomalies, including cleft lip and palate or sub-mucosal cleft palate or any anatomic or systemic condition which would interfere with general anesthesia or removal of tonsils and adenoid tissue in the standard fashion
- •Obstructive breathing while awake that merits prompt AT in the opinion of the child's physician
- •Severe OSAS or significant hypoxemia requiring immediate AT as defined by: OAI>20 or AHI>30, desaturation defined as oxygen saturation (SaO2) <90% for more than 2% sleep time
- •Apnea hypopnea indices in the normal range (OAI < 1 and AHI <2)
- •Evidence of clinically significant cardiac arrhythmia on PSG: Non-sustained ventricular tachycardia Atrial fibrillation, Second degree atrioventricular (AV) block: Sustained bradycardia < 40 bpm (> 2 minutes, Sustained tachycardia > 140 bpm (> 2 minutes)
- •Extremely overweight defined as: body mass index > 2.99 age group and sex-z-score
- •Severe health problems that could be exacerbated by delayed treatment for OSAS Including: Doctor-diagnosed heart disease or cor pulmonale, history of Stage II Hypertension (HTN) defined as > 99% percentile plus 5 mmHg for either systolic or diastolic, based on the age, gender, and height and/or requiring medication, therapy for failure to thrive or short stature, psychiatric or behavioral disorders requiring or likely to require initiation of new medication, therapy, or other specific treatment. School aged children, parental report of excessive daytime sleepiness defined as unable to maintain wakefulness, at least three times per week, in routine activities in school or home, despite adequate opportunity to sleep.
- •Severe chronic health conditions that might hamper participation including: severe cardiopulmonary disorders, sickle cell anemia, poorly controlled asthma, epilepsy requiring medication, diabetes (type I or type II) requiring medication, conditions likely to preclude accurate polysomnography (e.g. severe uncontrolled pain),mental retardation or enrollment in a formal school Individual Educational Plan (IEP) and assigned to a self-contained classroom for all academic subjects, history of inability to complete cognitive testing and/or score on the Differential Ability Scale (DAS) II of ≤ 55, chronic infection or HIV
- •Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition, or behavior
- •Current use of one or more of the following medications: psychotropics, hypnotics,hypoglycemic agents or insulin,antihypertensives,growth hormone, anticonvulsants,anti-coagulants,daily oral corticosteroids, daily medications for pain
- •Previous upper airway surgery on the nose, pharynx or larynx, including tonsillectomy. Ear surgery and/or pressure equalizing (PE) tubes are not exclusion criteria
- •Receives Continuous Positive Airway Pressure (CPAP) treatment
- •A parent or guardian who cannot accompany the child on the night of polysomnogram (PSG)
- •A family planning to move out of the area within the year
- •Female participants only: Parental report that child has reached menarche
研究组 & 干预措施
Early AT Surgery
There will be removal of tonsils and adenoids that will be performed within 4 weeks of the baseline visit.
干预措施: Adenotonsillectomy (AT) - removal of adenoids and tonsils (Procedure)
Watchful Waiting
Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
干预措施: Watchful Waiting (Other)
结局指标
主要结局
Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.
时间窗: The primary endpoint measure will occur at 7 months following the baseline visit.
The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.
次要结局
- Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months(7 months following the baseline visit.)
- Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale(7 months following baseline.)