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New treatment option for Otolaryngological Disease
Official title Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
ClinicalTrials.gov ID: NCT06258837
What this study is testing
- What it's testing
- The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils (ST). This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- To be in the study:
- 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.
- Child has small tonsils (Brodsky 1+ or 2+) noted during routine physical exam.
- Caregiver can provide signed and dated consent and is 18 years of age or older at the time of consent.
See the full eligibility criteria
- To be in the study:
- 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.
- Child has small tonsils (Brodsky 1+ or 2+) noted during routine physical exam.
- Caregiver can provide signed and dated consent and is 18 years of age or older at the time of consent.
- Caregiver can speak, read, and write in English or Spanish.
- Caregiver is primary caretaker of the child.
- Child is not expecting their own child.
- Child is eligible for surgical treatment Cannot be in the study if:
- Child has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy.
- Child has any contraindication to surgery (e.g. bleeding disorders).
- Child has significant cardiopulmonary comorbidity besides OSA requiring supplemental oxygen, subglottic or tracheal stenosis, tracheostomy dependence.
- Child has a genetic abnormality, Down syndrome, neuromuscular disorder, craniofacial anomaly.
- Caregiver is unwilling or unable to comply with study procedures.
- Child is or plans to become a parent themselves.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.