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Personalized Surgery for Sleep Apnea in Down Syndrome (TOPS-DS Trial)

N/A

Recruiting

Led By Derek Lam, MD, MPH

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child age is 2.00 to 17.99 years of age

Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5)

Must not have

Child has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy

Child has significant cardiopulmonary comorbidity besides OSA requiring supplemental oxygen, subglottic or tracheal stenosis, tracheostomy dependence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the effectiveness of personalized DISE-directed surgery vs AT in children with Down syndrome and OSA, to determine the best treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Surgical side effects may include pain, bleeding, infection risk at the operation site, breathing difficulties post-surgery, reactions from anesthesia used during DISE and surgery, and potential need for further interventions if initial surgery doesn't resolve OSA.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 2 and 17 years old.

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My child has been diagnosed with moderate to severe sleep apnea.

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My child has Down syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child has had surgery to remove their tonsils.

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My child needs extra oxygen or has serious heart/lung issues besides sleep apnea.

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My child cannot have surgery due to a medical condition like bleeding disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline Polysomnography Measures: % Total Sleep Time with ETCO2 > 50 mmHg at 6 months

Change from Baseline Polysomnography Measures: AHI at 6 months

Change from Baseline Polysomnography Measures: Max End Tidal CO2 (ETCO2) at 6 months

+4 more

Secondary study objectives

Adverse Events

Change in Feeding and Swallowing Impact Survey (FSIS) Questionnaire Answers

Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire answers

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Drug-Induced Sleep EndoscopyExperimental Treatment1 Intervention

DISE will be performed at the time of surgery under the same sedation. The decision on specific surgical approach will be made at that time based on DISE findings. Prior to intubation, patients will be sedated with either a propofol infusion or a combination of ketamine and dexmedetomidine. Once adequate sedation is achieved, endoscopy will be performed using a flexible endoscope advanced through the nose. The nasal airway will be evaluated on both sides, then the endoscope will be advanced into the pharynx. The degree of obstruction is scored on a 3-point rating scale. Participants randomized to DISE-directed surgery will undergo one or more potential procedures in a single surgery. Caregivers will be consented for all possible procedures with the understanding that only those needed based on DISE will be performed. Importantly, these procedures are all established treatments with published outcomes data.

Group II: AdenotonsillectomyActive Control1 Intervention

Adenotonsillar hypertrophy is the most common risk factor for OSA in children, and adenotonsillectomy (AT) is the first line treatment. An adenotonsillectomy is an operation to remove both the adenoids and tonsils.

0 / 6Eligibility criteria met