Treatment of Obstructive Sleep Apnea with Personalized Surgery in Children with Down Syndrome (TOPS-DS)
ABOUT THE TRIAL
What is obstructive sleep apnea?
Obstructive sleep apnea (OSA) is a common problem in children with Down Syndrome. The most common symptoms of OSA are heavy snoring and pauses in breathing at night. This can lead to restless sleep, waking up frequently, and daytime sleepiness. OSA in children is most often caused by large tonsils and adenoids, and the most common treatment is a surgery to remove the tonsils and adenoids. However, we know that in children with Down Syndrome, their throats can be more crowded than in other children, and sometimes removal of tonsils and adenoids does not work as well to treat the OSA.
Purpose of the study
The Treatment of Obstructive Sleep Apnea with Personalized Surgery in Children with Down Syndrome (TOPS-DS) trial is a research study comparing removal of tonsils and adenoids with a “personalized” sleep surgery that is tailored to the child’s anatomy, possibly including other parts of the upper airway that may also be causing snoring.
A personalized sleep surgery could be more effective than the standard removal of tonsils and adenoids in children with Down syndrome, but the two treatments have never been directly compared. This study will help us to learn more about the best way to treat sleep apnea in children with Down syndrome.
Read more on ClinicalTrials.gov.
What is a “personalized” sleep surgery?
A personalized sleep surgery is a surgery for OSA that is based on findings during a diagnostic endoscopy done under a sedation, or a light general anesthetic. In this procedure, a flexible endoscope is used to examine the upper airway during sedated sleep, and then a surgical procedure is designed that targets the specific parts of the throat causing obstruction. The personalized surgery could include just removal of tonsils and adenoids if those are the only causes of obstruction, but it could also address other areas in the upper airway (for example the back of the tongue or the soft palate) if they are contributing to obstruction as well.
PARTICIPATE
Reasons to Participate: | Who may participate? |
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What treatments are being compared?
To treat a diagnosis of sleep apnea, your child will be randomly assigned to either:
removal of tonsils and adenoids
OR
personalized surgery targeting the parts of the upper airway that are obstructive
This treatment option will start with a diagnostic sleep endoscopy, and then could include procedures involving the nose, adenoids, soft palate, tonsils, back of tongue, or voice box, depending on what areas are found to obstructive during diagnostic sleep endoscopy. In some cases, this may be only the tonsils and adenoids, in other cases it may target other areas entirely and leave the tonsils and adenoids alone, depending on what appears involved.
What is involved?
Over a period of 6-12 months, all children in the study will receive:
2 sleep studies (before and after surgery)
2 clinic visits
One of two treatment options described above
Parent-completed questionnaires
Please keep in mind:
Participation is voluntary.
You are free to withdraw from this study at any time.
We encourage you to ask questions and express all concerns.
We can offer limited reimbursement for your time and expenses.
SITES
Recruiting Centers | Coordinating Center |
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Cincinnati Children's Hospital and Medical Center: | Oregon Health & Science University: Email: topsds@ohsu.edu |
Eastern Virginia Medical School: | |
Oregon Health & Science University: | |
University of Michigan: | |
University of Texas-Southwestern: |