Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils

Description

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. It is the investigators' central hypothesis that a personalized drug-induced sleep endoscopy (DISE)-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction (ie, anatomic endotypes) in each child with ST will perform better than the currently recommended standard 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. To test this hypothesis, the investigators propose to study children aged 2-17 years with small tonsils and OSA.

Conditions

Otolaryngological Disease, Obstructive Sleep Apnea

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Study Overview

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Study Details

Study overview

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. It is the investigators' central hypothesis that a personalized drug-induced sleep endoscopy (DISE)-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction (ie, anatomic endotypes) in each child with ST will perform better than the currently recommended standard 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. To test this hypothesis, the investigators propose to study children aged 2-17 years with small tonsils and OSA.

Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils

Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils

Condition
Otolaryngological Disease
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 pregnant.
  • * Child is eligible for surgical treatment
  • * 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 pregnant.

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Oregon Health and Science University,

Derek Lam, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

2028-09-30