Pediatric Adenotonsillectomy Trial for Snoring

Sleep-Disordered Breathing Clinical Trial

— PATS  

Official title:

Impact of Treatment of Mild Sleep-Disordered Breathing on Children's Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562040
• Other study ID #: 2014P001798
• Secondary ID: 1U011HL125307-O1
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: November 1, 2022

Study information

• Verified date: March 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: November 1, 2022
• Est. primary completion date: February 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep-Disordered Breathing

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University Hospitals-Case Medical Center	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Children's Hospital of the King's Daughters	Norfolk	Virginia
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (9)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Boston Children's Hospital, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Children's Hospital of The King's Daughters, University Hospitals Cleveland Medical Center, University of Michigan, University of Rochester, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

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* Note: There are 77 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Behavior Rating Inventory of Executive Function (BRIEF) Global Composite Score.	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.	12 months
Primary	Change from baseline in Go-No-Go (GNG) signal detection parameter d-prime (d').	Change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d').	12 months
Secondary	GNG Continuous Performance Task (CPT) inhibitory control parameter d'.	Inhibitory control (response inhibition) assessed by GNG CPT inhibitory control parameter d'.	Baseline and 12 months
Secondary	NIH-Toolbox 9-Hole Pegboard Dexterity Test	Fine motor coordination assessed by NIH-Toolbox 9-Hole Pegboard Dexterity Test.	Baseline and 12 months
Secondary	BRIEF meta-cognition and emotional regulation summary scores and subscales.	Executive function assessed by BRIEF summary scores and subscales, parent and teacher ratings.	Baseline and 12 months
Secondary	Child Behavior Checklist (CBCL) summary scale and subscores.	Behavior assessed by CBCL summary scores and subscales, parent and teacher ratings.	Baseline and 12 months
Secondary	Conners 3 Short Form Content Scale T-scores.	Attention assessed by Conners 3 Short Form Content Scale T-scores, teacher and parent ratings.	Baseline and 12 months
Secondary	Pediatric Sleep Questionnaire: Sleep-Related Breathing Disorder Scale (PSQ-SRBD) total score.	Sleep-disordered breathing (SDB) symptoms assessed by PSQ-SRBD total score.	Baseline and 12 months
Secondary	Epworth Sleepiness Scale (ESS) Modified for Children summary score and PSQ-SRBD sleepiness subscale.	Sleepiness assessed by ESS summary score and PSQ-SRBD sleepiness subscale.	Baseline and 12 months
Secondary	Snoring	Quantitative snoring measure assessed via TASCAM snoring sensor.	Baseline and 12 months
Secondary	Pediatric Quality of Life Inventory (PedsQL) total score and subscores.	General quality of life assessed by PedsQL total score and subscores.	Baseline and 12 months
Secondary	Quality of Life Survey Evaluation of Sleep-Disordered Breathing (OSA-18) total score.	Disease-specific quality of life as assessed by OSAS-18 total score.	Baseline and 12 months
Secondary	Height (cm)	Standing height (to 0.1 cm) measured via calibrated stadiometer.	Baseline and 12 months
Secondary	Weight (kg)	Weight (to 0.1 kg) measured via calibrated digital electronic scale.	Baseline and 12 months
Secondary	Body Mass Index (BMI) Z-score	BMI Z-score calculated from in clinic ht/wt measures.	Baseline and 12 months
Secondary	Regional Fat Distribution	Fat distribution assessed via measurements of hip, neck and waist circumference taken with a calibrated measuring tape.	Baseline and 12 months
Secondary	Blood pressure	Measurements of systolic, diastolic and mean blood pressure.	Baseline and 12 months
Secondary	Healthcare Utilization	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.	12 months

External Links

•   PATS study portal