Healthy Sleep for Children With Down Syndrome

Status: Completed
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 13
Healthy Volunteers: f
View:

• DS diagnosis regardless of genetic status (e.g., mosaicism or translocation).

• Aged \>3 to \<13 years at the date of consent.

• Primary indication for AT is nocturnal obstructive symptoms (i.e., not recurrent infections or other indications).

• Deemed to be a candidate for AT by Ear, Nose and Throat (ENT) evaluation; that is, no technical issues that would be a contraindication for surgery such as submucous cleft palate.

Locations
United States
Michigan
University of Michigan Health System
Ann Arbor
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
University Hospitals-Case Medical Center
Cleveland
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Texas
University of Texas Southwestern Medical Center
Dallas
Virginia
Children's Hospital of the King's Daughters
Norfolk
Time Frame
Start Date: 2019-05-22
Completion Date: 2021-12-31
Participants
Target number of participants: 26
Treatments
DS peds eligible for Adenotonsillectomy
Dyads of caregivers and children with DS aged 3-13 years diagnosed with SDB and referred for treatment with adenotonsillectomy.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: University of Rochester, University of Michigan, 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 Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov