Clinical trial NCT02562040: Pediatric Adenotonsillectomy Trial for Snoring
Official title: Impact of Treatment of Mild Sleep-Disordered Breathing on Children's Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep-Disordered Breathing
Keywords: Pediatrics
Primary Snoring
Adenotonsillectomy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: University Hospitals Cleveland Medical Center
name: Children's Hospital Medical Center, Cincinnati
name: University of Michigan
name: University of Texas Southwestern Medical Center
name: University of Rochester
name: Children's Hospital of The King's Daughters
name: Boston Children's Hospital
First posted: 2015-09-29
Enrollment: 459
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Change From Baseline to 12 Months in Caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T Score
timeFrame: 12 months
measure: Change From Baseline to 12 Months in Go-No-Go (GNG) Signal Detection Parameter D-prime (d').
timeFrame: 12 months
Secondary outcomes:
measure: Change From Baseline to 12 Months in NIH-Toolbox 9-Hole Pegboard Dexterity Test Time
timeFrame: 12 months
measure: Change From Baseline to 12 Months in Child Behavior Checklist (CBCL) Summary Scale T Scores
timeFrame: 12 months
measure: Change From Baseline to 12 Months in Pediatric Sleep Questionnaire: Sleep-Related Breathing Disorder Scale (PSQ-SRBD) Total Score.
timeFrame: 12 months
measure: Change From Baseline to 12 Months in Sleepiness Measured by Change in the Epworth Sleepiness Scale (ESS) Modified for Children Summary Score.
timeFrame: 12 months
measure: Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales.
timeFrame: 12 months
measure: Change From Baseline to 12 Months in Quality of Life Survey Evaluation of Sleep-Disordered Breathing (OSA-18) Total Score.
timeFrame: 12 months
measure: Change From Baseline to 12 Months in Body Mass Index (BMI) Percentile
timeFrame: 12 months
measure: Change From Baseline to 12 Months in Mean Systolic and Diastolic Blood Pressures (mmHg) Percentile Scores.
timeFrame: 12 months
measure: Change From Baseline to 12 Months in Average Heart Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals-Case Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
Study officials:
affiliation: Brigham and Women's Hospital
name: Susan S Redline, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Rui Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Susan L. Furth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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