Surgical Treatment of Children With OSA and Small Tonsils or Down Syndrome

NCT05154214 | Completed

• 1 other identifier: STUDY00023287
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to prospectively compare the effectiveness of a novel personalized approach to the surgical treatment of obstructive sleep apnea (OSA) in children, drug induced sleep endoscopy (DISE) directed surgery versus the standard adenotonsillectomy (AT). This will also serve to test the feasibility of recruiting families for a future randomized protocol comparing the same surgical techniques. It is the investigators' central hypothesis that a personalized 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 small tonsils or Down syndrome will be superior to 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 will study children aged 2 to 18 years with clinically small tonsils (Brodsky score 1+ or 2+ on a scale 1+ to 4+) OR Down syndrome.

Conditions

Obstructive Sleep Apnea of Child

Keywords

Adenotonsillectomy; Drug-induced sleep endoscopy; pediatric; otolaryngology; OSA; sleep apnea; Down Syndrome

Outcome Measures

Primary Outcomes (5)

• Change in Pediatric Quality of Life (PedsQL), a generic quality of life scale

  Parent and child-reported surveys, higher scores indicate better quality of life, mean scores 0-100

  6 months post-surgery

• Parent-reported ease of participation

  Parent-reported survey or parent interview

  6 months post-surgery

• Parent-reported barriers to recruitment

  Parent-reported survey or parent interview

  Initial visit

• Change in Obstructive Sleep Apnea -18 (OSA-18): disease-specific quality of life survey

  Parent-reported survey, higher scores mean higher disease burden, scores from 18-126

  6 months post-surgery

• Parent-reported barriers to recruitment

  Parent-reported survey or parent interview

  6 months post-surgery

Secondary Outcomes (8)

• Change in Obstructive Apnea-Hypopnea Index (oAHI)

  6 months post-surgery

• Change in Total Apnea-Hypopnea Index

  6 months post-surgery

• Change in REM Apnea-Hypopnea Index (REM AHI)

  6 months post-surgery

• Change in Minimum Oxygen Saturation (Min SpO2)

  6 months post-surgery

• Change in Mean End Tidal CO2 (ETCO2)

  6 months post-surgery

Study Arms (2)

Adenotonsillectomy

Excision of the palatine tonsils and excision or ablation of the adenoids by each individual surgeon's preferred techniques.

Procedure: Adenotonsillectomy

Drug-induced sleep endoscopy directed surgery (DISE)

DISE will be performed by the surgeon performing the surgical intervention. The DISE Rating Scale assesses the degree of maximal closure or obstruction at six locations in the upper airway: the nose, nasopharynx (adenoids), velopharynx (soft palate), oropharynx (tonsils), tongue base (tongue, lingual tonsils), and larynx (epiglottis, arytenoids). The degree of obstruction is scored on a 3-point rating scale as none (0), partial (+1), or complete (+2) at each anatomic site. The rating at each anatomic level can be summed into a DISE Rating Scale total. The actual surgery performed will determine which established surgical treatments will be used based on the results of the DISE.

Procedure: Drug-induced sleep endoscopy directed surgery

Interventions

Adenotonsillectomy PROCEDURE

Removal of tonsils and adenoids

Adenotonsillectomy

Drug-induced sleep endoscopy directed surgery PROCEDURE

Surgeries selected based on direct visualization of airway collapse using endoscopy during drug-induced sleep

Drug-induced sleep endoscopy directed surgery (DISE)

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the Oregon Health and Science University pediatric otolaryngology clinic and from the pediatric sleep medicine clinic.

You may qualify if:

• Moderate OSA (oAHI ≥ 5),
• Clinically small tonsils (Brodsky score 1+ or 2+) AND/OR Down syndrome
• Desiring surgical treatment.
• English or Spanish speaking

You may not qualify if:

• Non-Down Syndrome neuromuscular disorder, craniofacial anomaly, genetic abnormality, subglottic or tracheal stenosis, tracheostomy dependence.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Down Syndrome

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Derek J Lam, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 13, 2021
• Study Start: November 9, 2021
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)