CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Adenotonsillectomyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03922165
NCT03922165N/ACompleted
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Healthy Sleep for Children With Down Syndrome

Brigham and Women's Hospital·observational·Posted Apr 19, 2019·Updated Mar 2, 2022

In Brief

An observational study evaluating Adenotonsillectomy for Down Syndrome and Sleep Disordered Breathing. Completed, enrolled 26 participants across 6 sites.

Detailed Summary

The purpose of this multi-center observational study (utilizing the sites enrolling patients for the Pediatric Adenotonsillectomy Trial for Snoring (PATS) \[1U011HL125307-O1A1\]) is to gather data regarding children with Down syndrome (DS) and Sleep Disordered Breathing (SDB) referred for treatment with adenotonsillectomy to inform a future randomized controlled trial in this population.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDown Syndrome, Sleep Disordered Breathing
CountriesUnited States
CollaboratorsChildren's Hospital of Philadelphia, University Hospitals Cleveland Medical Center, Children's Hospital Medical Center, Cincinnati, University of Michigan, University of Texas Southwestern Medical Center, University of Rochester, Children's Hospital of The King's Daughters

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 19, 2019
Enrollment StartMay 22, 2019
Primary CompletionDec 20, 2021
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.2 years ago

Interventions

Adenotonsillectomyprocedure

Routine AT per clinical care.