Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
459 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-06-06
Study Completion Date
2022-02-28
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Sleep-Disordered Breathing
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
Watchful Waiting with Supportive Care (WWSC)
Intervention Type
BEHAVIORAL
Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
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
Group Type
EXPERIMENTAL
Early Adenotonsillectomy (eAT)
Intervention Type
PROCEDURE
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.
Interventions
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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.
Intervention Type
PROCEDURE
Watchful Waiting with Supportive Care (WWSC)
Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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).
* 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.
* 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.
Minimum Eligible Age
3 Years
Maximum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
Sponsor Role
collaborator
University Hospitals Cleveland Medical Center
OTHER
Sponsor Role
collaborator
Children's Hospital Medical Center, Cincinnati
OTHER
Sponsor Role
collaborator
University of Michigan
OTHER
Sponsor Role
collaborator
University of Texas Southwestern Medical Center
OTHER
Sponsor Role
collaborator
University of Rochester
OTHER
Sponsor Role
collaborator
Children's Hospital of The King's Daughters
OTHER
Sponsor Role
collaborator
Boston Children's Hospital
OTHER
Sponsor Role
collaborator
Brigham and Women's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Susan Redline
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Susan S Redline, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Rui Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Susan L. Furth, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Site Status
University of Michigan Health System
Ann Arbor, Michigan, United States
Site Status
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Site Status
University Hospitals-Case Medical Center
Cleveland, Ohio, United States
Site Status
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Site Status
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Site Status
Countries
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United States
References
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Robinson KA, Wei Z, Radcliffe J, Taylor HG, Baldassari CM, Chervin RD, Ishman S, Mitchell RB, Tapia IE, Garetz S, Hassan F, Ibrahim S, Elden LM, Ievers-Landis CE, Williamson AA, Hjelm M, Kirkham E, Tham A, Naqvi K, Rueschman M, Rosen CL, Wang R, Redline S. Associations of actigraphy measures of sleep duration and continuity with executive function, vigilance, and fine motor control in children with snoring and mild sleep-disordered breathing. J Clin Sleep Med. 2023 Sep 1;19(9):1595-1603. doi: 10.5664/jcsm.10620.
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Wang R, Bakker JP, Chervin RD, Garetz SL, Hassan F, Ishman SL, Mitchell RB, Morrical MG, Naqvi SK, Radcliffe J, Riggan EI, Rosen CL, Ross K, Rueschman M, Tapia IE, Taylor HG, Zopf DA, Redline S. Pediatric Adenotonsillectomy Trial for Snoring (PATS): protocol for a randomised controlled trial to evaluate the effect of adenotonsillectomy in treating mild obstructive sleep-disordered breathing. BMJ Open. 2020 Mar 15;10(3):e033889. doi: 10.1136/bmjopen-2019-033889.
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Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1U011HL125307-O1A1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2014P001798
Identifier Type: -
Identifier Source: org_study_id
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