Pediatric Adenotonsillectomy Trial for Snoring
Condition: Sleep-Disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Early Adenotonsillectomy (eAT); Watchful Waiting with Supportive Care (WWSC)
Intervention type(s): Procedure; Behavioral
Intervention description(s): 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.; Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatrics; Primary Snoring; Adenotonsillectomy