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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Oregon Health and Science University
Study ID
NCT06258837
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea
  • Otolaryngological Disease

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • DISE-Directed Surgery — PROCEDURE
    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 — PROCEDURE
    Tonsil and/or adenoid removal

Study Details

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.

Key Dates

Start date
Oct 4, 2024
Status verified
Sep 2025
Primary completion
Jun 1, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Brittany Nordhaus
[email protected]
Erin Kirkham, MD, MPH (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Eleni O'Neill
[email protected]
503-875-9895
Derek Lam, MD, MPH (PRINCIPAL_INVESTIGATOR)

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University of Michigan· Ann Arbor, MIOregon Health and Science University· Portland, OR

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