Recruiting

Personalized Surgery

Sponsor:

Oregon Health and Science University

Code:

NCT06258837

Conditions

Otolaryngological Disease

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

DISE-Directed Surgery

Adenotonsillectomy

Study Details

Brief summary:

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

Study ID

NCT06258837

Start date

Oct 4, 2024

Status verified date

Jul, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

175 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Drug-Induced Sleep Endoscopy

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.

active comparator: Adenotonsillectomy

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.

Interventions

DISE-Directed Surgery

Participants randomized to DISE-directed surgery will undergo one or more potential procedures in a single surgery (i.e. DISE and subsequent sleep surgery performed) concurrently under the same general anesthetic), depending on anatomic assessment.

Adenotonsillectomy

Tonsil and/or adenoid removal

Primary outcome measure

  • Change from Baseline Polysomnography Measures: Obstructive Apnea-Hypopnea Index (oAHI) at 6 months [ Time Frame: 6 month follow up sleep study (after surgery) ]
  • Change from Baseline Polysomnography Measures: Total Apnea-Hypopnea Index (AHI) at 6 months [ Time Frame: 6 month follow up sleep study (after surgery) ]
  • Change from Baseline Polysomnography Measures: REM Apnea-Hypopnea Index (REM AHI) at 6 months [ Time Frame: 6 month follow up sleep study (after surgery) ]
  • Change from Baseline Polysomnography Measures: minimum Oxygen saturation (SpO2) at 6 months [ Time Frame: 6 month follow up sleep study (after surgery) ]
  • Change from Baseline Polysomnography Measures: Oxyhemoglobin desaturation ≥ 3% Index (desat index) at 6 months [ Time Frame: 6 month follow up sleep study (after surgery) ]
  • Change from Baseline Polysomnography Measures: Percent Total Sleep Time with ETCO2 > 50 mmHg at 6 months [ Time Frame: 6 month follow up sleep study (after surgery) ]
  • Change from Baseline Polysomnography Measures: Max End Tidal CO2 (ETCO2) at 6 months [ Time Frame: 6 month follow up sleep study (after surgery) ]

Central Contacts and Locations

Central contacts

Eleni O'Neill

503-494-3569topsst@ohsu.edu

Derek Lam, MD

503-494-9419lamde@ohsu.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Brittany Nordhaus

nbrittan@med.umich.edu

Principal Investigator:

Erin Kirkham, MD, MPH

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Eleni O'Neill

503-875-9895topsst@ohsu.edu

Principal Investigator:

Derek Lam, MD, MPH

More Information

Sponsor

Oregon Health and Science University

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-07-06.