NCT06258837 · Oregon Health and Science University
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
(TOPS-ST)
What this study is about
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.
View original scientific 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.
Interventions
PROCEDURE
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.
PROCEDURE
Adenotonsillectomy
Tonsil and/or adenoid removal
Primary outcome measures
Change from Baseline Polysomnography Measures: Obstructive Apnea-Hypopnea Index (oAHI) at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): Obstructive Apnea-Hypopnea Index (oAHI): 6 months follow up sleep study difference from baseline sleep study. Higher scores indicate higher disease burden. Scores can range from zero to two hundred.
Change from Baseline Polysomnography Measures: Total Apnea-Hypopnea Index (AHI) at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): Total Apnea-Hypopnea Index: 6 months follow up sleep study difference from baseline sleep study. Higher scores indicate higher disease burden. Scores can range from zero to two hundred.
Change from Baseline Polysomnography Measures: REM Apnea-Hypopnea Index (REM AHI) at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): REM Apnea-Hypopnea Index REM AHI: 6 months follow up sleep study difference from baseline sleep study. Higher scores indicate higher disease burden. Scores can range from zero to two hundred.
Change from Baseline Polysomnography Measures: minimum Oxygen saturation (SpO2) at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): Minimum Oxygen Saturation (Min SpO2): 6 months follow up sleep study difference from baseline sleep study. Lower scores indicate higher disease burden. Scores range from 0-100, although neither extreme is actually seen in patients.
Change from Baseline Polysomnography Measures: Oxyhemoglobin desaturation ≥ 3% Index (desat index) at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Oxyhemoglobin desaturation ≥ 3% Index: 6 months follow up sleep study difference from baseline sleep study. Higher scores mean higher disease burden. Mild desaturation (\< 5.0 events/h), moderate desaturation (≥ 5.0 events/h and \< 10.0 events/h), and severe desaturation (≥ 10.0 events/h).
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)
% Total Sleep Time with ETCO2 \> 50 mmHg: 6 months follow up sleep study difference from baseline sleep study. Higher scores mean higher disease burden. Scores range from 0-100.
Change from Baseline Polysomnography Measures: Max End Tidal CO2 (ETCO2) at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Max End Tidal CO2 (ETCO2): 6 months follow up sleep study difference from baseline sleep study. Higher scores mean higher disease burden. Normal is 35-40 mmHg.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Where
- Ann Arbor, Michigan
- Portland, Oregon
Collaborators
University of Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations