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Personalized Surgery for Obstructive Sleep Apnea (TOPS-ST Trial)

N/A

Waitlist Available

Led By Derek Lam, MD

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

Child age is 2.00 to 17.99 years of age

Must not have

Child has a genetic abnormality, Down syndrome, neuromuscular disorder, craniofacial anomaly

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare a new personalized surgical method to the standard method for treating obstructive sleep apnea in children with small tonsils. The new method involves using drug-induced sleep endoscopy to

Who is the study for?

This trial is for children aged 2-17 years who have obstructive sleep apnea (OSA) but small tonsils. They should not have had previous surgery for OSA. The study aims to find a better surgical treatment tailored to each child's specific anatomy.

What is being tested?

The study compares two surgeries: a personalized approach using drug-induced sleep endoscopy (DISE) to tailor the surgery to the child's needs, and the standard adenotonsillectomy (AT), which removes tonsils and adenoids.

What are the potential side effects?

Potential side effects may include typical surgical risks such as pain, bleeding, infection, or reactions to anesthesia. Specific side effects will depend on the individualized procedure each child receives.

Eligibility Criteria

Inclusion Criteria

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

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

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My child is between 2 and 17 years old.

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My child is not pregnant.

Exclusion Criteria

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

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My child has a genetic condition like Down syndrome or a neuromuscular disorder.

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My child has had surgery to remove their tonsils.

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My child cannot have surgery due to health risks like bleeding disorders.

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My child needs extra oxygen or has serious breathing issues not related to sleep apnea.

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: Max End Tidal CO2 (ETCO2) at 6 months

Change from Baseline Polysomnography Measures: Obstructive Apnea-Hypopnea Index (oAHI) at 6 months

Change from Baseline Polysomnography Measures: Oxyhemoglobin desaturation ≥ 3% Index (desat index) at 6 months

+4 more

Secondary study objectives

Adverse Events

Change in Child Behavior Checklist (CBCL) 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 / 7Eligibility criteria met