RecruitingNot Applicable

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

United States240 participantsStarted 2024-10-04

Plain-language 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.

Who can participate

Age range2 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change from Baseline Polysomnography Measures: Obstructive Apnea-Hypopnea Index (oAHI) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: Total Apnea-Hypopnea Index (AHI) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: REM Apnea-Hypopnea Index (REM AHI) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: minimum Oxygen saturation (SpO2) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: Oxyhemoglobin desaturation ≥ 3% Index (desat index) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: Percent Total Sleep Time with ETCO2 > 50 mmHg at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: Max End Tidal CO2 (ETCO2) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Trial details

NCT IDNCT06258837

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-01

Contact for this trial

Eleni O'Neill

503-494-3569 oneilele@ohsu.edu

View on ClinicalTrials.gov More Otolaryngological Disease trials

Plain-language summary

Who can participate

Age range2 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline Polysomnography Measures: Obstructive Apnea-Hypopnea Index (oAHI) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: Total Apnea-Hypopnea Index (AHI) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: REM Apnea-Hypopnea Index (REM AHI) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: minimum Oxygen saturation (SpO2) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: Oxyhemoglobin desaturation ≥ 3% Index (desat index) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: Percent Total Sleep Time with ETCO2 > 50 mmHg at 6 months

Timeframe: 6 month follow up sleep study (after surgery)

Change from Baseline Polysomnography Measures: Max End Tidal CO2 (ETCO2) at 6 months

Timeframe: 6 month follow up sleep study (after surgery)