Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Otolaryngological Disease
- Sponsor
- Oregon Health and Science University
- Enrollment
- 240
- Locations
- 2
- Primary Endpoint
- Change from Baseline Polysomnography Measures: Total Apnea-Hypopnea Index (AHI) at 6 months
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief 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.
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.
Investigators
Derek Lam, MD, MPH
Associate Professor of Otolaryngology - Head and Neck Surgery
Oregon Health and Science University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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: 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: 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: 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.
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: 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).
Secondary Outcomes
- Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire score(6 month follow up)
- Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire answers(6 month follow up)
- Total Drug induced sleep endoscopy (DISE) score(At time of surgery)
- Adverse Events(24 hour period after surgery)
- Change in Obstructive Sleep Apnea (OSA)-18 Questionnaire score(6 month follow up)
- Change in Child Behavior Checklist (CBCL) Questionnaire answers(Baseline versus 6 month follow up)