Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)

NARecruitingINTERVENTIONAL
Enrollment

303

Participants

Timeline

Start Date

August 2, 2023

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Obstructive Sleep ApneaDown Syndrome
Interventions
PROCEDURE

DISE-Directed Surgery

Participants randomized to DISE-directed surgery will undergo one or more potential procedures in a single surgery (i.e. DISE and subsequent sleep surgery performed) concurrently under the same general anesthetic), depending on anatomic assessment.

PROCEDURE

Adenotonsillectomy

Tonsil and adenoid removal

Trial Locations (7)

23507

RECRUITING

EVMS Medical School, Norfolk

45229

ACTIVE_NOT_RECRUITING

Cincinnati Children's Hospital, Cincinnati

48109

RECRUITING

University of Michigan, Ann Arbor

75235

RECRUITING

UT Southwestern Medical Center, Dallas

77030

NOT_YET_RECRUITING

Texas Children's Hospital, Houston

80045

NOT_YET_RECRUITING

Colorado Children's Hospital, Aurora

97239

RECRUITING

Oregon Health and Science University, Portland

All Listed Sponsors
collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

University of Michigan

OTHER

collaborator

University of Texas

OTHER

collaborator

Eastern Virginia Medical School

OTHER

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Texas Children's

UNKNOWN

collaborator

Children's Hospital Colorado

OTHER

lead

Oregon Health and Science University

OTHER