Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-17
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
DISE-Directed Surgery
Procedure/SurgeryParticipants 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/SurgeryTonsil and/or adenoid removal
Treatment groups
175 Participants
are divided into 2 treatment groupsGroup A: Drug-Induced Sleep EndoscopyExperimental treatment 1 intervention
Group B: AdenotonsillectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline Polysomnography Measures: Obstructive Apnea-Hypopnea Index (oAHI) at 6 months
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.
Time frame
6 month follow up sleep study (after surgery)2
Change from Baseline Polysomnography Measures: Total Apnea-Hypopnea Index (AHI) at 6 months
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.
Time frame
6 month follow up sleep study (after surgery)3
Change from Baseline Polysomnography Measures: REM Apnea-Hypopnea Index (REM AHI) at 6 months
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.
Time frame
6 month follow up sleep study (after surgery)4
Change from Baseline Polysomnography Measures: minimum Oxygen saturation (SpO2) at 6 months
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.
Time frame
6 month follow up sleep study (after surgery)Secondary outcomes
1
Change in Obstructive Sleep Apnea (OSA)-18 Questionnaire score
Disease specific quality of life measure: 18 questions, scores range from 18-126; higher scores means higher disease burden
Time frame
6 month follow up2
Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire score
Generic quality of life measure: an age specific questionnaire with 23 questions (scores range from 0-100); higher scores indicate better quality of life.
Time frame
6 month follow up3
Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire answers
Quality of life: questionnaire results by individual question. Adjusted scores range from 0-100; higher scores indicate better quality of life.
Time frame
6 month follow up4
Total Drug induced sleep endoscopy (DISE) score
Subjective ratings of degree of obstruction at 6 levels of the upper airway, done by surgeon. Scores range from 0 to 12. Higher scores means more breathing obstruction, or more disease burden.
Time frame
At time of surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
University of Michigan
Collaborator
Source ClinicalTrials.gov