Pediatric Adenotonsillectomy for Snoring

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.

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.