Computer Models of Airways in Children and Young Adults With Sleep Apnea and Down Syndrome

NCT01902407 | Enrolling By Invitation

• 2 other identifiers: CIN001-DymosaR01HL105206-01
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to develop a way of predicting with computers how surgery on the airway will affect night time breathing called Obstructive Sleep Apnea (OSA) in children with Down Syndrome. A research measurement for airway resistance will also be done during the clinical sleep MRI. The airway resistance measurement will take about 10 minutes and is done during sleep. The airway resistance measurement is called critical closing pressure (Pcrit).

Conditions

Down Syndrome; Obstructive Sleep Apnea

Keywords

Pcrit; Critical closing pressure; Down syndrome; Obstructive Sleep Apnea; Sleep MRI

Outcome Measures

Primary Outcomes (1)

• Measurement of critical closing pressure of the airway-Sleep MRI

  Measured in mmH2O

  Day 1

Study Arms (1)

Diagnostic MRI and CT scan of the airway

All patients seen at CCHMC (up to 90 years of age) who are scheduled to have a clinical sleep MRI or CT scan for their OSA airway or lung disease. Scheduled for both Sleep diagnostic tests (Sleep MRI and CT scans).

Eligibility Criteria

• Age: 1 Year - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients seen at CCHMC (up to 90 years of age) who are scheduled to have a clinical sleep MRI or CT scan for their OSA airway or lung disease. Scheduled for both Sleep diagnostic tests (Sleep MRI and CT scans)

You may qualify if:

• All patients seen at CCHMC (up to 90 years of age) who are scheduled to have a clinical sleep MRI or CT scan for their OSA airway or lung disease.
• Both Sleep diagnostic tests (Sleep MRI and CT scans).

You may not qualify if:

• Those patients whose body weight (\>350 pounds) or circumference is greater than what can be safely accommodated by the MRI scanner
• Patients with pacemakers or other non-MRI compatible devices
• Patients with extensive dental hardware that causes MR artifact obscuring visualization of the area of interest.
• Body Mass Index (BMI) \> 40

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Mahmoud M, Ishman SL, McConnell K, Fleck R, Shott S, Mylavarapu G, Gutmark E, Zou Y, Szczesniak R, Amin RS. Upper Airway Reflexes are Preserved During Dexmedetomidine Sedation in Children With Down Syndrome and Obstructive Sleep Apnea. J Clin Sleep Med. 2017 May 15;13(5):721-727. doi: 10.5664/jcsm.6592.

  PMID: 28356179 DERIVED

MeSH Terms

Conditions

Down Syndrome; Sleep Apnea, Obstructive

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; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Raouf Amin, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: July 18, 2013
• Study Start: March 1, 2011
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-04

Locations

US (1)