Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DISE-Directed Surgery, Adenotonsillectomy.
- Who it may be relevant to
- Registry conditions: Otolaryngological Disease, Obstructive Sleep Apnea. Basic parameters: 2 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Obstructive sleep apnea (OSA) is common in children with an estimated prevalence of 1-6%. Untreated pediatric OSA is associated with hypertension, autonomic dysfunction, attention-deficit / hyperactivity disorder, neurocognitive deficits, poor school performance, poor quality of life, and a \>200% increase in health care utilization compared to controls. Adenotonsillar hypertrophy is the primary risk factor for pediatric OSA, and adenotonsillectomy (AT) is the recommended first line treatment. However, the prevalence of persistent OSA after AT has been reported to be at least 20% among children with large tonsils, indicating that AT may not be the optimal intervention in all cases. Although the prevalence of small tonsils in children with OSA symptoms is up to 70%, there is currently no clear evidence on the outcome of AT in children with small tonsils. It has been shown that clinic assessments of tonsil size do not correlate with OSA severity or response to AT, leaving confusion about how best to treat OSA in children with small tonsils. This knowledge gap represents an opportunity to apply a personalized treatment approach and improve outcomes.
DISE entails passage of a flexible endoscope through the nose into the pharynx and enables direct observation of the sites and patterns of upper airway obstruction during sedated sleep. DISE was developed to guide surgical decisions in adult OSA, and in recent years has also been used to design personalized surgical interventions in children. To help standardize DISE assessments, the investigators previously developed and validated the DISE Rating Scale in children based on ordinal ratings of maximal airway obstruction (none, partial, complete) at six anatomic sites from the nose to the larynx.
The investigators also demonstrated that DISE ratings of adenotonsillar obstruction during sedated sleep are strongly associated with both OSA severity and response to AT, unlike clinic assessments of tonsil size. The investigators' preliminary data and other published studies have identified a high prevalence of non-adenotonsillar obstruction that can occur at the nose, palate, base of tongue, and larynx. Surgery that is tailored to the specific anatomic sites of obstruction observed during DISE may improve pediatric OSA outcomes, but existing studies are small, uncontrolled case series in heterogeneous study populations. There are no trials directly comparing AT and DISE-directed surgery in the common scenario of surgically naïve children with small tonsils.
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 (i.e., 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)]
- Change from Baseline Polysomnography Measures: Total Apnea-Hypopnea Index (AHI) at 6 months [Time frame: 6 month follow up sleep study (after surgery)]
- Change from Baseline Polysomnography Measures: REM Apnea-Hypopnea Index (REM AHI) at 6 months [Time frame: 6 month follow up sleep study (after surgery)]
- Change from Baseline Polysomnography Measures: minimum Oxygen saturation (SpO2) at 6 months [Time frame: 6 month follow up sleep study (after surgery)]
- Change from Baseline Polysomnography Measures: Oxyhemoglobin desaturation ≥ 3% Index (desat index) at 6 months [Time frame: 6 month follow up sleep study (after surgery)]
- 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)]
- Change from Baseline Polysomnography Measures: Max End Tidal CO2 (ETCO2) at 6 months [Time frame: 6 month follow up sleep study (after surgery)]
Secondary outcome measures (6)
- Change in Obstructive Sleep Apnea (OSA)-18 Questionnaire score [Time frame: 6 month follow up]
- Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire score [Time frame: 6 month follow up]
- Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire answers [Time frame: 6 month follow up]
- Total Drug induced sleep endoscopy (DISE) score [Time frame: At time of surgery]
- Adverse Events [Time frame: 24 hour period after surgery]
- Change in Child Behavior Checklist (CBCL) Questionnaire answers [Time frame: Baseline versus 6 month follow up]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Michigan — Ann Arbor
- Oregon Health and Science University — Portland
Identifiers
NCT: NCT06258837 · STUDY00027270