Pediatric Adenotonsillectomy Trial for Snoring | NCT02562040

NCT02562040

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
1U011HL125307-O1A1	Other Grant/Funding Number	NHLBI

Status Module

Name	Class
Children's Hospital of Philadelphia	OTHER
University Hospitals Cleveland Medical Center	OTHER
Children's Hospital Medical Center, Cincinnati	OTHER

Description Module

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:

Assess outcomes important to children and their families, particularly patient-reported outcomes such as behavior, quality of life, and sleep disturbances.
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.
Evaluate health care utilization of children with mild sleep disordered breathing.
Assess moderating influences such as second hand smoke, insufficient sleep, socioeconomic status and family functioning
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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Watchful Waiting with Supportive Care	Active Comparator	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.	Behavioral: Watchful Waiting with Supportive Care (WWSC)
Early Adenotonsillectomy	Experimental	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	Procedure: Early Adenotonsillectomy (eAT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early Adenotonsillectomy (eAT)	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to 12 Months in Caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T Score	The BRIEF GEC section comprises summary measures of behavioral regulation, emotion regulation, and cognitive regulation (BRIEF-2, for children aged 5 to 18 years) or inhibitory self-control, flexibility, and emergent metacognition (BRIEF-P, for preschool-aged children). These scores are linear transformations of the raw scores (mean = 50, sd = 10) where a higher T score indicates a child has a lower capacity to organize and self-regulate.	12 months
Change From Baseline to 12 Months in Go-No-Go (GNG) Signal Detection Parameter D-prime (d').	Performance on combined Go-No-Go (GNG)/Continuous Performance Test (CPT) task was assessed by tracking accuracy responses to targets (fish) and false positive responses to non-targets (sharks). d' is computed for both portions of the task as an assessment of accuracy in making correct detections adjusting for the participant's tendency to respond to non-targets. The adjusted measure is computed by subtracting Z-scores for false positive responses from Z-scores for correct detections. Individual Z-scores were based on a child's performance within same age groups (3-4, 5-6 , and >=7 years old). Scores ranged across age groups from -0.53 to 3.99 for GNG and -0.61 to 4.35 for CPT. Higher scores reflect better discrimination of targets from non-targets. A value of 4.65 represents 100% accuracy, 0 represents chance performance, and minus scores represent more frequent detection of non-targets than targets, suggesting a child misunderstood instructions or preferred responding to non-targets.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to 12 Months in NIH-Toolbox 9-Hole Pegboard Dexterity Test Time	Fine motor coordination assessed by the time (in seconds) it takes a child to complete the NIH-Toolbox 9-Hole Pegboard Dexterity Test. Shorter times indicate greater dexterity. The reported value is the average of the dominant and non-dominant hand scores.	12 months

Eligibility Module

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.

Name	Affiliation	Role
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	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Boston Children's Hospital		Boston	Massachusetts	02115	United States
University of Michigan Health System

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20974339	Background	Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.
21493257	Background	Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.

Label	URL
PATS study portal	View source

Arm/Group Information

ID	Title	Description
FG000	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. Watchful Waiting with Supportive Care (WWSC): Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
FG001	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 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	Early Adenotonsillectomy

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous		Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to 12 Months in Caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T Score

The BRIEF GEC section comprises summary measures of behavioral regulation, emotion regulation, and cognitive regulation (BRIEF-2, for children aged 5 to 18 years) or inhibitory self-control, flexibility, and emergent metacognition (BRIEF-P, for preschool-aged children). These scores are linear transformations of the raw scores (mean = 50, sd = 10) where a higher T score indicates a child has a lower capacity to organize and self-regulate.

All participants with valid measurements at both baseline and 12-months are included

Posted

Mean

Standard Deviation

change in score on a scale

12 months

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

ID	Term
D057832	Watchful Waiting
D010166	Palliative Care

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration