Personalized Surgery for Obstructive Sleep Apnea in Children with Small Tonsils
This study is looking at new ways to treat obstructive sleep apnea (OSA) in children aged 2 to 17 who have small tonsils. It compares two surgical approaches: a standard tonsil and/or adenoid removal (Adenotonsillectomy) and a personalized surgery guided by DISE (Drug-Induced Sleep Endoscopy). DISE involves using a small camera to look at your child's airway during sedated sleep to find out exactly what is causing the blockage. The goal is to see if the personalized surgery works better than the standard approach after 6 months. To join, your child must have moderate to severe OSA and small tonsils. The study is currently unclear about its recruitment status and plans to enroll 175 participants.
- Study design
- This study will randomly assign children to receive either DISE-Directed Surgery or Adenotonsillectomy. It plans to enroll 175 participants.
- What's involved
- Your child will undergo a sleep study before surgery and another one 6 months after surgery to measure changes in their sleep apnea.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after surgery to assess the effectiveness of the treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Derek Lam, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change from Baseline Polysomnography Measures: Obstructive Apnea-Hypopnea Index (oAHI) at 6 months6 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 months6 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 months6 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 months6 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 months6 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 months6 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 months6 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.