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Surgery

Early Adenotonsillectomy (eAT) for Sleep Apnea (PATS Trial)

N/A
Waitlist Available
Led By Susan L. Furth, MD, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

PATS Trial Summary

This trial will test whether early adenotonsillectomy improves behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but don't have obstructive sleep apnea.

Eligible Conditions
  • Sleep Apnea

PATS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Behavior Rating Inventory of Executive Function (BRIEF) Global Composite Score.
Change from baseline in Go-No-Go (GNG) signal detection parameter d-prime (d').
Secondary outcome measures
BRIEF meta-cognition and emotional regulation summary scores and subscales.
Blood pressure
Body Mass Index (BMI) Z-score
+13 more

PATS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early AdenotonsillectomyExperimental Treatment1 Intervention
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 II: Watchful Waiting with Supportive CareActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Early Adenotonsillectomy (eAT)
2016
N/A
~460

Find a Location

Who is running the clinical trial?

University of RochesterOTHER
835 Previous Clinical Trials
517,867 Total Patients Enrolled
1 Trials studying Sleep Apnea
50 Patients Enrolled for Sleep Apnea
University of Texas Southwestern Medical CenterOTHER
1,046 Previous Clinical Trials
1,053,315 Total Patients Enrolled
2 Trials studying Sleep Apnea
188 Patients Enrolled for Sleep Apnea
Children's Hospital of The King's DaughtersOTHER
12 Previous Clinical Trials
1,466 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to enroll in this clinical trial?

"459 minors aged between 3 and 12, who struggle with respiratory aspiration, have been accepted into this clinical trial. In addition to age criteria, participants must also satisfy the following conditions: Tonsillar hypertrophy ≥2 based on a standardized 0-4 scale; regular nocturnal snoring for at least three months that occurs more than half of sleep time on at least three nights per week; Polysomnogram (PSG) confirming an obstructive apnea index (OAI) <1/hour and apnea-hypopnea index (AHI) ≤3/hour without oxygen desaturation below 90"

Answered by AI

Does this clinical trial accept participants who are beyond their mid-thirties?

"This particular trial is seeking patients in the 3-12 age range, while there are 46 trials for minors and 274 studies targeting seniors."

Answered by AI

Are there any vacancies remaining in this research undertaking?

"As reflected on clinicaltrials.gov, this medical experiment is no longer accepting patients. It was initially posted on June 1st 2016 and edited most recently on July 18th 2022. Despite the closure of recruitment for this trial, there are still 337 other trials actively enrolling participants at present."

Answered by AI

How many venues is this clinical experiment being conducted in currently?

"Currently, this clinical experiment is being carried out at 7 separate locations. These sites are located in Norfolk, Philadelphia and Ann Arbor with 4 other centres scattered across the country. It would be beneficial to select a local clinic to spare patients from long-distance travel should they choose to take part."

Answered by AI

What aims is this clinical trial attempting to accomplish?

"The primary endpoint assessed over the course of a year is Change from baseline in Go-No-Go (GNG) signal detection parameter d'-prime. Secondary outcomes include GNG Continuous Performance Task (CPT) inhibitory control parameter d', Height, and BRIEF meta-cognition and emotional regulation summary scores and subscales.."

Answered by AI
Recent research and studies
~52 spots leftby Apr 2025