Pediatric Adenotonsillectomy Trial for Snoring (PATS)

This is an interventional treatment trial for Sleep-Disordered Breathing focused on measuring Pediatrics, Primary Snoring, Adenotonsillectomy Read More

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.