Pediatric Adenotonsillectomy Trial for Snoring (PATS)
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|ClinicalTrials.gov Identifier: NCT02562040|
Recruitment Status : Recruiting
First Posted : September 29, 2015
Last Update Posted : January 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sleep-Disordered Breathing||Procedure: Early Adenotonsillectomy (eAT) Behavioral: Watchful Waiting with Supportive Care (WWSC)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||460 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Impact of Treatment of Mild Sleep-Disordered Breathing on Children's Health|
|Actual Study Start Date :||June 2016|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||October 2021|
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.
Behavioral: Watchful Waiting with Supportive Care (WWSC)
Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
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
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.
- 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').
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562040
|Contact: Michael G Morricalfirstname.lastname@example.org|
|Contact: Jessie P Bakker, PhDemail@example.com|
|United States, Massachusetts|
|Boston Children's Hospital||Terminated|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|University of Michigan Health System||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator: Ronald D Chervin, MD|
|Sub-Investigator: Fauziya Hassan, MBBS, MS|
|Sub-Investigator: Susan L Garetz, MD|
|Sub-Investigator: David A Zopf, MD|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator: Raouf S Amin, MD|
|Sub-Investigator: Stacey L Ishman, MD, MPH|
|University Hospitals-Case Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator: Carol L Rosen, MD|
|Sub-Investigator: Kristie R Ross, MD|
|Sub-Investigator: Hudson G Taylor, PhD|
|Sub-Investigator: Jay Shah, MD|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator: Ignacio E Tapia, MD|
|Sub-Investigator: Jerilynn Radcliffe, PhD|
|Sub-Investigator: Lisa M Elden, MD MS FRCSC|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Principal Investigator: Ronald B Mitchell, MD|
|Sub-Investigator: Kamal M Naqvi, MD|
|United States, Virginia|
|Children's Hospital of the King's Daughters||Recruiting|
|Norfolk, Virginia, United States, 23507|
|Principal Investigator: Christina M Baldassari, MD|
|Sub-Investigator: Michael J Strunc, MD|
|Sub-Investigator: Jennifer L Wiebke, MD|
|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|