Mode
Text Size
Log in / Sign up
N/A N=459 Randomized Single-blind Treatment

Pediatric Adenotonsillectomy Trial for Snoring

Sleep-Disordered Breathing

Enrolled (actual)
459
Serious AEs
4.8%
Results posted
Nov 2024
Primary outcome: Primary: Change From Baseline to 12 Months in Caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T Score — -1.90; -3.08 change in score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Early Adenotonsillectomy (eAT) (Procedure); Watchful Waiting with Supportive Care (WWSC) (Behavioral)
Age
Pediatric · 3+ yrs
Sex
All
Sponsor
Brigham and Women's Hospital
Primary completion
Feb 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline to 12 Months in Caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T Score
-1.90; -3.08
PRIMARY
Change From Baseline to 12 Months in Go-No-Go (GNG) Signal Detection Parameter D-prime (d').
1.9; 3.1
SECONDARY
Change From Baseline to 12 Months in NIH-Toolbox 9-Hole Pegboard Dexterity Test Time
-5.9; -5.3
SECONDARY
Change From Baseline to 12 Months in Child Behavior Checklist (CBCL) Summary Scale T Scores
-1.44; -4.55
SECONDARY
Change From Baseline to 12 Months in Pediatric Sleep Questionnaire: Sleep-Related Breathing Disorder Scale (PSQ-SRBD) Total Score.
-0.07; -0.23
SECONDARY
Change From Baseline to 12 Months in Sleepiness Measured by Change in the Epworth Sleepiness Scale (ESS) Modified for Children Summary Score.
-0.67; -1.77
SECONDARY
Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales.
-2.62; 2.09; -5.34; 0.74; -1.08; 2.85
SECONDARY
Change From Baseline to 12 Months in Quality of Life Survey Evaluation of Sleep-Disordered Breathing (OSA-18) Total Score.
-6.03; -15.77
SECONDARY
Change From Baseline to 12 Months in Body Mass Index (BMI) Percentile
3.23; 5.09
SECONDARY
Change From Baseline to 12 Months in Mean Systolic and Diastolic Blood Pressures (mmHg) Percentile Scores.
4.75; -4.5; 2.20; -4.87
SECONDARY
Change From Baseline to 12 Months in Average Heart Rate
-1.80; -1.97

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02562040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search