303 Participants Needed

Personalized Surgery for Sleep Apnea in Down Syndrome

(TOPS-DS Trial)

Recruiting at 6 trial locations
EO
DL
Overseen ByDerek Lam, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The overall objective of this randomized clinical trial is to test the effectiveness of a personalized approach to the surgical treatment of OSA in children with Down syndrome (DS).The estimated prevalence of obstructive sleep apnea (OSA) in children with DS ranges from 45-83%, compared to 1-6% in the general pediatric population. Untreated OSA in children has been associated with daytime sleepiness, cognitive or behavioral problems, and cardiovascular complications, all which are common in children with DS. Adenotonsillectomy (AT) is the first line treatment for OSA in children, however, most large studies of AT outcomes have excluded children with DS. Available evidence demonstrates that AT is far less effective in children with DS than in the general pediatric population, with 48 to 95% of children with DS having persistent OSA after AT. Medical treatments such as positive airway pressure (PAP) therapy are frequently inadequate or poorly tolerated in this population, so many children with DS and OSA remain untreated. Drug-induced sleep endoscopy (DISE) enables direct observation of the sites and patterns of obstruction during sedated sleep using a flexible endoscope passed through the nose into the pharynx. DISE was developed to guide surgical decisions in adult OSA, and in recent years has also been used to design personalized surgical interventions in children. Using this DISE Rating Scale, the investigators have demonstrated that children with DS are more prone to tongue base and supraglottic obstruction than non-DS children, suggesting the need for more personalized surgical treatments that are tailored to the common sources of obstruction in this population. Several small case series demonstrate that DISE-directed surgery can be effective in treating OSA in children with DS. However, because there have been few prospective studies and no randomized trials comparing different treatment options in this population, there remains uncertainty about whether such a personalized approach leads to superior outcomes compared to the first line AT.It is the investigators' hypothesis that personalized DISE-directed surgery that uses existing procedures to address specific fixed and dynamic anatomic features causing obstruction in each child with DS will be superior to the current first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.

Is personalized surgery for sleep apnea in Down Syndrome generally safe for humans?

The studies suggest that drug-induced sleep endoscopy (DISE)-directed surgery, including procedures like adenotonsillectomy, is generally safe for children with obstructive sleep apnea, including those with Down Syndrome. These procedures have been performed in various studies without significant safety concerns reported.12345

How is the treatment for sleep apnea in children with Down syndrome unique?

This treatment is unique because it uses drug-induced sleep endoscopy (DISE) to guide surgery, allowing doctors to identify and address specific sites of airway obstruction, which is particularly beneficial for children with Down syndrome who often have persistent sleep apnea even after standard adenotonsillectomy.12467

What data supports the effectiveness of this treatment for sleep apnea in children with Down Syndrome?

Research shows that drug-induced sleep endoscopy (DISE)-directed surgery can be effective for children with Down Syndrome who have persistent sleep apnea after adenotonsillectomy. In one study, 44% of these children had their sleep apnea significantly improved after DISE-directed treatment.12458

Who Is on the Research Team?

DL

Derek Lam, MD, MPH

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for children aged 2 to 17 with Down syndrome and moderate to severe obstructive sleep apnea (OSA), who haven't had tonsil surgery before. Caregivers must be able to communicate in English or Spanish, give consent, and commit to the study's procedures. Children with significant heart/lung issues besides OSA or conditions that make surgery risky are excluded.

Inclusion Criteria

Child is not pregnant
Caregiver is primary caretaker of the child
My child is a candidate for surgery.
See 5 more

Exclusion Criteria

Caregiver is unwilling or unable to comply with study procedures
My child needs extra oxygen or has serious heart/lung issues besides sleep apnea.
My child cannot have surgery due to a medical condition like bleeding disorders.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either DISE-directed surgery or adenotonsillectomy (AT) for the treatment of OSA

Single surgery event
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including polysomnography and quality of life measures

6 months
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Adenotonsillectomy
  • DISE-Directed Surgery
Trial Overview The trial tests personalized surgical treatment for OSA against the standard adenotonsillectomy (AT) in kids with Down syndrome. It uses drug-induced sleep endoscopy (DISE) to tailor surgeries based on each child's specific airway blockages during sedated sleep.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Drug-Induced Sleep EndoscopyExperimental Treatment1 Intervention
Group II: AdenotonsillectomyActive Control1 Intervention

Adenotonsillectomy is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Adenotonsillectomy for:
🇪🇺
Approved in European Union as Adenotonsillectomy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

Texas Children's

Collaborator

Trials
2
Recruited
270+

Children's Hospital Colorado

Collaborator

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121
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5,135,000+

University of Michigan

Collaborator

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1,891
Recruited
6,458,000+

Eastern Virginia Medical School

Collaborator

Trials
77
Recruited
16,500+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

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3,987
Recruited
47,860,000+

University of Texas

Collaborator

Trials
193
Recruited
143,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials
844
Recruited
6,566,000+

Published Research Related to This Trial

In a study of 16 children with Down syndrome who had persistent obstructive sleep apnea (OSA) after adenotonsillectomy, drug-induced sleep endoscopy (DISE) effectively identified the sites of airway obstruction, allowing for targeted surgical interventions.
Post-operative results showed significant improvements in sleep apnea parameters, with 44% of the patients achieving normalization of their apnea-hypopnea index, indicating that DISE-directed treatment is a promising option for managing persistent OSA in this population.
Persistent Obstructive Sleep Apnea in Children with Down Syndrome After Adenotonsillectomy: Drug Induced Sleep Endoscopy-Directed Treatment.Abdel-Aziz, M., Abdel-Naseer, U., Elshahawy, E., et al.[2022]
In a study of 56 children with obstructive sleep apnea (OSA), those who underwent drug-induced sleep endoscopy (DISE)-directed surgery showed a significant improvement in their obstructive Apnea-Hypopnea Index (oAHI), with 54% achieving an oAHI of less than 5 events per hour post-surgery.
The study found that while various surgical procedures were performed, only the race of the children (specifically white race) was a significant predictor of achieving a successful outcome (oAHI <5) after the surgery.
Outcomes of Drug-Induced Sleep Endoscopy-Directed Surgery for Pediatric Obstructive Sleep Apnea.He, S., Peddireddy, NS., Smith, DF., et al.[2019]
In a study of 24 children with Down Syndrome and obstructive sleep apnea who underwent drug-induced sleep endoscopy (DISE)-directed surgery, improvements were noted in all polysomnography (PSG) parameters, indicating potential benefits of this surgical approach.
The most significant improvement was observed in the oxygen nadir for children who had previously undergone adenotonsillectomy, suggesting that DISE-directed surgery can enhance oxygen levels during sleep in this specific group.
Does drug induced sleep endoscopy-directed surgery improve polysomnography measures in children with Down Syndrome and obstructive sleep apnea?Akkina, SR., Ma, CC., Kirkham, EM., et al.[2019]

Citations

Persistent Obstructive Sleep Apnea in Children with Down Syndrome After Adenotonsillectomy: Drug Induced Sleep Endoscopy-Directed Treatment. [2022]
Outcomes of Drug-Induced Sleep Endoscopy-Directed Surgery for Pediatric Obstructive Sleep Apnea. [2019]
Does drug induced sleep endoscopy-directed surgery improve polysomnography measures in children with Down Syndrome and obstructive sleep apnea? [2019]
Polysomnography outcomes in children with small tonsils undergoing drug-induced sleep endoscopy-directed surgery. [2020]
Drug induced sleep endoscopy in the decision-making process of children with obstructive sleep apnea. [2022]
Drug-induced sleep endoscopy-directed adenotonsillectomy in pediatric obstructive sleep apnea with small tonsils. [2020]
Obstructive sleep apnea in Down syndrome children: a surgical approach. [2022]
Tonsillectomy and adenoidectomy in patients with Down syndrome. [2019]
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