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Down SyndromeDYMOSANCT01902407

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

An observational study of Down Syndrome and Obstructive Sleep Apnea, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 90 years
Conditions the study is for
Down Syndrome, Obstructive Sleep Apnea
How many people
81 participants
Where
1 siteUnited States
Study dates
1 Mar 2011to 26 Feb 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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)

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Dynamic Computational Modeling of Obstructive Sleep Apnea in Down Syndrome

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).

Read the detailed description

This is a proof-of-concept study to determine if a dynamic computational model can be used to predict surgical outcomes. If the results from the study are positive, they can be used to help design a larger subsequent study. The purpose of this research is to develop a computational model that simulates OSA and different surgical treatments for OSA in children and young adults with DS. Thus, the only population that will be studied is children and young adults with DS who have persistent OSA despite having previously undergone T\&A.

Obstructive sleep apnea (OSA) occurs in 50-100% of patients with Down syndrome (DS) and can significantly cause and exacerbate medical problems in these patients. Current surgical management of children with DS is imperfect. There are variable surgical success rates for both first line surgery of palatine tonsillectomy and adenoidectomy (T\&A) as well as secondary surgeries performed if and when T\&A fails. There is a critical need for a diagnostic modality that takes into account airway anatomy, tissue compliance, and collapsibility to be able to predict surgical outcome and improve surgical planning in these patients. Our central hypothesis is that upper airway flow-structure interaction (FSI) modeling using three-dimensional (3-D) computational simulations from dynamic magnetic resonance imaging (MRI or MR) data can be used to predict surgical outcomes for children with DS who have OSA despite previous T\&A. The long-term goal is to improve surgical outcome of children with Down syndrome and OSA by creating an accurate FSI predictive model. Such a diagnostic tool would help tailor surgical procedures to be more effective as well as identify and avoid unnecessary or unhelpful surgical procedures. These created models can in future be adjusted and applied to other populations with OSA. Our specific aims include: 1) In children with Down syndrome and persistent OSA despite previous T\&A, to collect data characterizing upper airway anatomy, tissue compliance, and collapsibility; 2) to generate and validate individualized dynamic FSI models for each child and 3) to use the validated dynamic computational models to predict the success of surgical treatment on children with Down syndrome who have persistent OSA despite previous T\&A. This work is innovative as it uses dynamic rather than static MR imaging data and applies a unique computational model that accurately captures the unsteadiness of the flow and accounts for the interaction between the airflow and the surrounding airway flexible structures.

Research components will involve two parts of the project. The first will be the generation, validation and use of computational models from MRI data. The second is the measure of critical closing pressure (Pcrit) on DS subjects who are at least three months post T\&A, have OSA and are being evaluated for possible additional airway surgery. The measurement of Pcrit will be done during the research PSG (in the Sleep Center) and during the clinical sleep MRI (in the MRI suite). Pcrit measurements will be acquired with the use of a Continuous Positive Air Pressure (CPAP) mask during sleep. Additionally, to measure improvement in OSA based on quality of life (QOL) and sleep, the Obstructive Sleep Apnea questionnaire (OSA18) will be administered both preoperatively and postoperatively.

Keywords
Pcrit, Critical closing pressure, Down syndrome, Obstructive Sleep Apnea, Sleep MRI
Medical subject headings
Down Syndrome, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01902407
Study groupRoleWhat they receive
Diagnostic MRI and CT scan of the airwayAll 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of critical closing pressure of the airway-Sleep MRI

    Measured in mmH2O

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2013 (estimated)
  2. Study start1 Mar 2011
  3. Primary completion26 Feb 2026
  4. Study completion26 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01902407
Sponsor's protocol ID
CIN001-Dymosa
Other IDs
R01HL105206-01
Acronym
DYMOSA
Status last verified
Oct 2026
First submitted
7 May 2013
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28356179

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