Pediatric Adenotonsillectomy Trial for Snoring

N/ACompletedNCT02562040

Brigham and Women's Hospital459 enrolled

Overview

The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but do not have obstructive sleep apnea, as well as identify factors that moderate responses to the surgery. Half of participants will receive eAT, while the other half will be observed with watchful waiting and supportive care.

Adenotonsillectomies are performed more than 500,000 times per year in the United States, and is the most common surgery performed under general anesthesia in children. The majority of surgeries are performed for obstructed breathing rather than for infection or other indications. The role of adenotonsillectomy (AT) in improving the 7-month neurocognitive, behavioral and health outcomes of children with frank obstructive sleep apnea (OSA) was recently addressed in the Childhood Adenotonsillectomy Trial (CHAT). The results of this rigorous, multicenter, randomized controlled trial provided critically important data indicating that adenotonsillectomy compared to watchful waiting resulted in improved behavior, quality of life, sleep-disordered breathing (SDB) symptoms and polysomnographic parameters. However, the Childhood Adenotonsillectomy Trial addressed the role of surgery in the minority of operative candidates who have frank obstructive sleep apnea, only one form of sleep disordered breathing on a spectrum that includes a more common phenotype, primary snoring (also termed mild sleep disordered breathing (MSDB)). Mild sleep disordered breathing is characterized by snoring without frank obstruction or gas exchange abnormalities, and has a population prevalence of about 10% in children. Since most surgeries for obstructed breathing are performed for mild sleep disordered breathing rather than obstructive sleep apnea, the next logical question is whether surgery is also effective in improving symptoms and health outcomes in this large group of children. The Pediatric Adenotonsillectomy Trial for Snoring (PATS) intends to take advantage of a successful collaboration of leaders in sleep medicine, otolaryngology and clinical trials to efficiently leverage experiences from the CHAT trial to evaluate the role of adenotonsillectomy in children with mild sleep disordered breathing while also aiming to resolve uncertainties regarding management approaches for pediatric mild sleep disordered breathing by addressing several critical issues: 1. Assess outcomes important to children and their families, particularly patient-reported outcomes such as behavior, quality of life, and sleep disturbances. 2. Examine differences in treatment responses among children who are at increased risk for mild sleep disordered breathing, such as pre-school children, minorities, and children with asthma or obesity. 3. Evaluate health care utilization of children with mild sleep disordered breathing. 4. Assess moderating influences such as second hand smoke, insufficient sleep, socioeconomic status and family functioning 5. Examine longer term (12 month) outcomes that were not feasible in the Childhood Adenotonsillectomy Trial (CHAT). These aims have substantial public health significance given the high morbidity of sleep disordered breathing in children.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

459

Conditions

Sleep-Disordered Breathing

Interventions

Early Adenotonsillectomy (eAT)PROCEDURE

Standard clinical adenotonsillectomy within 4 weeks post randomization in addition to information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.

Watchful Waiting with Supportive Care (WWSC)BEHAVIORAL

Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of mild sleep-disordered breathing (MSDB) defined as meeting all of the following criteria: * Caregiver report of habitual snoring that occurs most of the night on at least three nights per week, and has been present for at least three months (on average occurring \> 3 nights per week or more half of sleep time) and * Centrally-scored polysomnogram (PSG) confirming an obstructive apnea index (OAI) \<1/hour and apnea-hypopnea index (AHI) ≤3/hour and no oxygen saturation (SpO2) desaturation \< 90% in conjunction with obstructive events, confirmed on PSG. * Tonsillar hypertrophy ≥2 based on a standardized scale of 0-4. * Deemed to be a candidate for AT by otolaryngologist (ENT) evaluation (i.e., no technical issues that would be a contraindication for surgery such as submucous cleft palate.) * Primary indication for AT is nocturnal obstructive symptoms (i.e., not recurrent infections or other indications). Exclusion Criteria: * Previous tonsillectomy, including partial tonsillectomy * Recurrent tonsillitis that merits prompt adenotonsillectomy (AT) per the American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines (i.e., ≥7 episodes/yr in the past year; ≥5 episodes/year over the past 2 years or ≥3 episodes/yr over the past 3 years.) * Severe obesity (body mass index (BMI) z-score ≥3). * Failure to thrive, defined as either height or weight being below the 5th percentile for age and gender. * Severe chronic health conditions that might hamper participation or confound key variables under study, including but not limited to: * Severe cardiopulmonary disorders such as cystic fibrosis, and congenital heart disease. * Bleeding disorders * Sickle Cell Disease * Epilepsy requiring medication * Significant cardiac arrhythmia noted on PSG including: non-sustained ventricular tachycardia, atrial fibrillation, second degree atrioventricular block, sustained bradycardia, or sustained tachycardia. * Other severe chronic health problems such as diabetes, narcolepsy, and poorly controlled asthma. * Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition or behavior; * Current use of psychotropic medication (other than medications for attention deficit hyperactivity disorder, hypnotics, antihypertensives, hypoglycemic agents including insulin, anticonvulsants, anticoagulants, or growth hormone. * Diagnosis of autism spectrum disorder. * Intellectual deficit or assigned to a self-contained classroom for all academic subjects. * History of severe developmental disability or Adaptive Behavior Assessment System (ABAS-3) score ≤60. * Children/caregivers planning to move out of the area within the year. * Children in foster care. * Children/caregivers who do not speak English or Spanish well enough to complete the neurobehavioral measures.

Locations (7)

Boston Children's Hospital

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

University Hospitals-Case Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Change From Baseline to 12 Months in Caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T Score

The BRIEF GEC section comprises summary measures of behavioral regulation, emotion regulation, and cognitive regulation (BRIEF-2, for children aged 5 to 18 years) or inhibitory self-control, flexibility, and emergent metacognition (BRIEF-P, for preschool-aged children). These scores are linear transformations of the raw scores (mean = 50, sd = 10) where a higher T score indicates a child has a lower capacity to organize and self-regulate.

Time frame: 12 months

Change From Baseline to 12 Months in Go-No-Go (GNG) Signal Detection Parameter D-prime (d').

Performance on combined Go-No-Go (GNG)/Continuous Performance Test (CPT) task was assessed by tracking accuracy responses to targets (fish) and false positive responses to non-targets (sharks). d' is computed for both portions of the task as an assessment of accuracy in making correct detections adjusting for the participant's tendency to respond to non-targets. The adjusted measure is computed by subtracting Z-scores for false positive responses from Z-scores for correct detections. Individual Z-scores were based on a child's performance within same age groups (3-4, 5-6 , and \>=7 years old). Scores ranged across age groups from -0.53 to 3.99 for GNG and -0.61 to 4.35 for CPT. Higher scores reflect better discrimination of targets from non-targets. A value of 4.65 represents 100% accuracy, 0 represents chance performance, and minus scores represent more frequent detection of non-targets than targets, suggesting a child misunderstood instructions or preferred responding to non-targets.

Time frame: 12 months

Secondary Outcomes

Change From Baseline to 12 Months in NIH-Toolbox 9-Hole Pegboard Dexterity Test Time

Fine motor coordination assessed by the time (in seconds) it takes a child to complete the NIH-Toolbox 9-Hole Pegboard Dexterity Test. Shorter times indicate greater dexterity. The reported value is the average of the dominant and non-dominant hand scores.

Time frame: 12 months

Data from ClinicalTrials.gov

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