Healthy Sleep for Children With Down Syndrome

NCT03922165 | Completed DMC

• 1 other identifier: 18-015848
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Down Syndrome; Sleep Disordered Breathing

Keywords

Pediatrics; Adenotonsillectomy

Outcome Measures

Primary Outcomes (2)

• % enrolled/approached

  Percentage of families approached for participation that sign informed consent to participate.

  1 year

• % retained/enrolled

  Percentage of consented families that completed study participation.

  1 year

Study Arms (1)

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.

Procedure: Adenotonsillectomy

Interventions

Adenotonsillectomy PROCEDURE

Routine AT per clinical care.

DS peds eligible for Adenotonsillectomy

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Dyads of caregivers and children with DS aged 3-13 years diagnosed with SDB and referred for treatment with adenotonsillectomy (AT) will be recruited.

You may qualify if:

• 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.

You may not qualify if:

• Prior tonsillectomy (partial or complete).
• Severe chronic health conditions that would contradict surgery (severe morbid obesity, unrepaired cyanotic congenital heart disease, bleeding disorders).
• Severe behavioral problems that would preclude participation in the study's testing procedures (PSG, actigraphy).
• Severe OSA with respiratory failure needing urgent/emergent management
• Plan to undergo additional airway surgery at the time of AT.
• Caregiver/child planning to move out of the area within 6 months.
• Caregiver/child does not speak English or Spanish well enough to complete the behavioral and performance measures.
• Child in foster care.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Children's Hospital of Philadelphia: collaborator
• University Hospitals Cleveland Medical Center: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• University of Michigan: collaborator
• University of Texas Southwestern Medical Center: collaborator
• University of Rochester: collaborator
• Children's Hospital of The King's Daughters: collaborator

Study Sites (6)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University Hospitals-Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Down Syndrome; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Susan S Redline, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Rui Wang, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Susan L Furth, Md, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: May 22, 2019
• Primary Completion: December 20, 2021
• Study Completion: December 31, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

US (6)