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Pediatric Adenotonsillectomy Trial for Snoring (PATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562040
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : March 23, 2023
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
University Hospitals Cleveland Medical Center
Children's Hospital Medical Center, Cincinnati
University of Michigan
University of Texas Southwestern Medical Center
University of Rochester
Children's Hospital of The King's Daughters
Boston Children's Hospital
Information provided by (Responsible Party):
Susan Redline, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE September 25, 2015
First Posted Date  ICMJE September 29, 2015
Last Update Posted Date March 23, 2023
Actual Study Start Date  ICMJE June 1, 2016
Actual Primary Completion Date February 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
  • Change from baseline in Behavior Rating Inventory of Executive Function (BRIEF) Global Composite Score. [ Time Frame: 12 months ]
    Change from baseline in executive behavior relating to self-regulation and organizational skills as measured by the Behavior Rating Inventory of Executive Function (BRIEF) Global Composite Score.
  • Change from baseline in Go-No-Go (GNG) signal detection parameter d-prime (d'). [ Time Frame: 12 months ]
    Change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d').
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
  • Change from baseline in Behavior Rating Inventory of Executive Function (BRIEF) Global Composite Score. [ Time Frame: 12 months ]
    Change from baseline in executive behavior relating to self-regulation and organizational skills (as measured by the Behavior Rating Inventory of Executive Function (BRIEF) Global Composite Score.
  • Change from baseline in Go-No-Go (GNG) signal detection parameter (d'). [ Time Frame: 12 months ]
    Change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d').
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
  • GNG Continuous Performance Task (CPT) inhibitory control parameter d'. [ Time Frame: Baseline and 12 months ]
    Inhibitory control (response inhibition) assessed by GNG CPT inhibitory control parameter d'.
  • NIH-Toolbox 9-Hole Pegboard Dexterity Test [ Time Frame: Baseline and 12 months ]
    Fine motor coordination assessed by NIH-Toolbox 9-Hole Pegboard Dexterity Test.
  • BRIEF meta-cognition and emotional regulation summary scores and subscales. [ Time Frame: Baseline and 12 months ]
    Executive function assessed by BRIEF summary scores and subscales, parent and teacher ratings.
  • Child Behavior Checklist (CBCL) summary scale and subscores. [ Time Frame: Baseline and 12 months ]
    Behavior assessed by CBCL summary scores and subscales, parent and teacher ratings.
  • Conners 3 Short Form Content Scale T-scores. [ Time Frame: Baseline and 12 months ]
    Attention assessed by Conners 3 Short Form Content Scale T-scores, teacher and parent ratings.
  • Pediatric Sleep Questionnaire: Sleep-Related Breathing Disorder Scale (PSQ-SRBD) total score. [ Time Frame: Baseline and 12 months ]
    Sleep-disordered breathing (SDB) symptoms assessed by PSQ-SRBD total score.
  • Epworth Sleepiness Scale (ESS) Modified for Children summary score and PSQ-SRBD sleepiness subscale. [ Time Frame: Baseline and 12 months ]
    Sleepiness assessed by ESS summary score and PSQ-SRBD sleepiness subscale.
  • Snoring [ Time Frame: Baseline and 12 months ]
    Quantitative snoring measure assessed via TASCAM snoring sensor.
  • Pediatric Quality of Life Inventory (PedsQL) total score and subscores. [ Time Frame: Baseline and 12 months ]
    General quality of life assessed by PedsQL total score and subscores.
  • Quality of Life Survey Evaluation of Sleep-Disordered Breathing (OSA-18) total score. [ Time Frame: Baseline and 12 months ]
    Disease-specific quality of life as assessed by OSAS-18 total score.
  • Height (cm) [ Time Frame: Baseline and 12 months ]
    Standing height (to 0.1 cm) measured via calibrated stadiometer.
  • Weight (kg) [ Time Frame: Baseline and 12 months ]
    Weight (to 0.1 kg) measured via calibrated digital electronic scale.
  • Body Mass Index (BMI) Z-score [ Time Frame: Baseline and 12 months ]
    BMI Z-score calculated from in clinic ht/wt measures.
  • Regional Fat Distribution [ Time Frame: Baseline and 12 months ]
    Fat distribution assessed via measurements of hip, neck and waist circumference taken with a calibrated measuring tape.
  • Blood pressure [ Time Frame: Baseline and 12 months ]
    Measurements of systolic, diastolic and mean blood pressure.
  • Healthcare Utilization [ Time Frame: 12 months ]
    Healthcare utilization assessed by total count of filled prescriptions and health care visits (scheduled and unscheduled), ascertained from billing and pharmacy records, caregiver reports, and EMR surveillance.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Adenotonsillectomy Trial for Snoring
Official Title  ICMJE Impact of Treatment of Mild Sleep-Disordered Breathing on Children's Health
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sleep-Disordered Breathing
Intervention  ICMJE
  • Procedure: Early Adenotonsillectomy (eAT)
    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.
  • Behavioral: Watchful Waiting with Supportive Care (WWSC)
    Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
Study Arms  ICMJE
  • Active Comparator: Watchful Waiting with Supportive Care
    All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
    Intervention: Behavioral: Watchful Waiting with Supportive Care (WWSC)
  • Experimental: Early Adenotonsillectomy
    All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
    Intervention: Procedure: Early Adenotonsillectomy (eAT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2022)		 459
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2015)		 460
Actual Study Completion Date  ICMJE November 1, 2022
Actual Primary Completion Date February 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02562040
Other Study ID Numbers  ICMJE 2014P001798
1U011HL125307-O1A1 ( Other Grant/Funding Number: NHLBI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Susan Redline, Brigham and Women's Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Brigham and Women's Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Children's Hospital of Philadelphia
  • University Hospitals Cleveland Medical Center
  • Children's Hospital Medical Center, Cincinnati
  • University of Michigan
  • University of Texas Southwestern Medical Center
  • University of Rochester
  • Children's Hospital of The King's Daughters
  • Boston Children's Hospital
Investigators  ICMJE
Principal Investigator: Susan S Redline, MD, MPH Brigham and Women's Hospital
Principal Investigator: Rui Wang, PhD Brigham and Women's Hospital
Principal Investigator: Susan L. Furth, MD, PhD Children's Hospital of Philadelphia
PRS Account Brigham and Women's Hospital
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP