Sponsor:
Brigham and Women's Hospital
Code:
NCT06043440
Conditions
Down Syndrome
Obstructive Sleep Apnea
Eligibility Criteria
Sex: All
Age: 5 - 18
Healthy Volunteers: Not accepted
Interventions
Oxygen
Brief summary:
Conditions
Down Syndrome
Obstructive Sleep Apnea
Study ID
NCT06043440
Start date
Oct 24, 2023
Status verified date
Apr, 2025
Completion date
Dec 30, 2027
Anticipated
Primary completion date
Nov 30, 2027
Anticipated
Eligibility Criteria
Sex: All
Age: 5 - 18
Healthy Volunteers: Not accepted
Enrollment
230 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
active comparator: Oxygen plus supportive care (OXT)
no intervention: Supportive care (SC)
Interventions
Oxygen
Primary outcome measure
Central contacts
Locations
Children's Hospital of Los Angeles
Recruiting
Los Angeles, California, United States, 90027
Contacts
Danny Del Cid-Linare
ddelcidlinares@chla.usc.eduPrincipal Investigator:
Sally Ward, MD
University of Michigan, Ann Arbor Hospital
Recruiting
Ann Arbor, Michigan, United States, 48109
Contacts
Emily Herreshoff
egalopin@med.umich.eduPrincipal Investigator:
Ronald Chervin, MD
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati, Ohio, United States, 45229
Contacts
Suzanna Hicks
suzanna.hicks@cchmc.orgPrincipal Investigator:
Raouf Amin, MD
Rainbow Babies and Children's Hospital, Case Medical Center
Recruiting
Cleveland, Ohio, United States, 44106
Contacts
Alyssa Keller
Alyssa.Keller@Uhhospitals.orgPrincipal Investigator:
Sally Ibrahim, MD
Children's Hospital of Philadelphia
Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contacts
Ebereh Uwah
uwahe@chop.eduPrincipal Investigator:
Christopher Cielo, MD
East Virginia Medical Center
Recruiting
Norfolk, Virginia, United States, 23507
Contacts
Thomas Boswick
BoswicST@EVMS.eduPrincipal Investigator:
Cristina Baldassari, MD
Seattle Children's Hospital
Recruiting
Seattle, Washington, United States, 98105
Contacts
Sharon McNamara
sharon.mcnamara@seattlechildrens.orgPrincipal Investigator:
Maida Chen, MD
Sponsor
Brigham and Women's Hospital
Last update posted
Apr 20, 2025
Last verified
Apr, 2025
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-04-20.