Study at UH Seeks Answers on the Best Treatment Approach for Childhood Snoring
February 25, 2019
NIH-funded PATS trial is enrolling children ages 3 to 12
UH Clinical Update - February 2019
The recent Childhood Adenotonsillectomy Trial (CHAT), published in The New England Journal of Medicine, showed that when compared to watchful waiting, adenotonsillectomy resulted in improved behavior, quality of life, sleep-disordered breathing (SDB) symptoms and polysomnographic parameters among children with frank obstructive sleep apnea (OSA).
However, CHAT only addressed the role of surgery among the minority of operative candidates who have frank OSA. Primary snoring, also termed mild sleep-disordered breathing (MSDB), is much more common, affecting about 10 percent of all children.
Now a new randomized, multi-center trial is under way to determine whether CHAT’s findings hold true for these kids.
“Since about one-half of surgeries for obstructed breathing are performed for MSDB rather than OSA, the next logical question is whether surgery is also effective in improving symptoms and health outcomes in this large group of children,” says Carol Rosen, MD, Director of the Pediatric Sleep Center at UH Rainbow Babies & Children’s Hospital.
Dr. Rosen and pediatric pulmonologist Kristie Ross, MD, are leading the UH arm of the new NIH-funded PATS (Pediatric Adenotonsillectomy for Snoring) trial.
The new trial is addressing gaps in the literature by enrolling very young children who are at greatest risk for MSDB, and by following children for a full year after intervention to obtain reliable estimates of changes in health care utilization that are not biased by seasonal effects. In addition, PATS investigators are analyzing factors that moderate the response to surgery: age, socioeconomic status, asthma and atopy, secondhand tobacco smoke exposure, family functioning, short sleep duration, obesity and minority status.
“PATS is providing data from a randomized controlled trial that for the first time addresses the role of adenotonsillectomy in children with MSDB and defines the subgroups most suitable for this procedure,” Dr. Rosen says.
The PATS trial at UH is currently enrolling children, ages 3 to 12, with snoring during sleep and who are being considered for adenotonsillectomy by their UH Rainbow ENT specialist. They should not be diagnosed with OSA or have had their tonsils removed. Study subjects are being randomly placed in one of two groups:
- Early removal of tonsils and adenoids about one month after sleep study
- Watchful waiting with supportive care for 12 months
All children in the study have:
- Two overnight sleep studies
- Three daytime visits, which will include:
- Behavioral testing
- Blood pressure measurement
- Body measurements
- Parent questionnaires
- Blood and urine test (during visit one only)
- Monthly telephone calls
- Actigraphy for seven days to measure the child’s wake and sleep cycles at home
- Teacher questionnaires