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This randomized trial showed no effect of early adenotonsillectomy, as compared with watchful waiting, on the primary outcome of attention and executive functioning in children with obstructive sleep apnea. Many secondary outcomes favored early surgery. The childhood obstructive sleep apnea syndrome is associated with numerous adverse health outcomes, including cognitive and behavioral deficits. 1 The most commonly identified risk factor for the childhood obstructive sleep apnea syndrome is adenotonsillar hypertrophy. Thus, the primary treatment is adenotonsillectomy, which accounts for more than 500,000 procedures annually in the United States alone. 2 Nevertheless, there has been no controlled study evaluating the benefits and risks of adenotonsillectomy, as compared with watchful waiting, for the management of the obstructive sleep apnea syndrome. The Childhood Adenotonsillectomy Trial (CHAT) was designed to evaluate the efficacy of early adenotonsillectomy versus watchful waiting with supportive . . .

Objective This study compares the efficacy of oral exercise alone to oral exercise with frenectomy in improving obstructive sleep apnea (OSA) symptoms and quality of life (QOL) in patients with ankyloglossia. Materials and methods A prospective, controlled, double-blind clinical study enrolled fifteen adults (20–60 years) newly diagnosed with mild to moderate OSA and ankyloglossia. Participants were randomly assigned to either oral exercise alone (control group; n  = 8) or oral exercise with frenectomy (intervention group; n  = 7). Outcomes were assessed after a 3-month therapy period using polysomnography, the Epworth Sleepiness Scale (ESS), tongue strength (measured in kPa), and QOL questionnaires. Results Both control (-2.88 ± 1.73; p  = 0.02) and intervention (-4.00 ± 3.65; p  = 0.03) groups showed a significant reduction in ESS scores, indicating both improved sleepiness. Although the apnea-hypopnea index (AHI) increased in both groups after treatment, these changes were not statistically significant (control 4.73 ± 15.55; p  = 0.48, intervention 10.42 ± 14.66; p  = 0.12). Tongue strength significantly increased in both groups: control group ( p  = 0.04) and intervention group ( p  = 0.03). Satisfaction rates with the overall treatment process were 100% in the control group and 57.1% in the intervention group. Furthermore, 75.0% and 57.1% of participants in the respective groups reported an improvement in QOL. Conclusion Frenectomy improved tongue mobility and the ability to perform oral exercises in individuals with OSA and ankyloglossia. However, these exercises did not significantly improve OSA-related symptoms or QOL. Clinical relevance While frenectomy enhances tongue mobility, thereby enabling better engagement in oral exercises. These exercises alone did not significantly improve OSA-related symptoms or QOL. This suggests that oral exercises focusing solely on tongue mobility may not be sufficient for managing OSA. Trial registration The Thai Clinical Trials Registry was TCTR20220429002.

Abstract Study Objectives The Sleep Apnea Multilevel Surgery (SAMS) trial found that modified uvulopalatopharyngoplasty with tonsillectomy (if tonsils present) combined with radiofrequency tongue ablation reduced obstructive sleep apnea (OSA) severity and daytime sleepiness in moderate-severe OSA. This study aimed to investigate mechanisms of effect on apnea-hypopnea index (AHI) reduction by assessing changes in upper airway volumes (airway space, soft palate, tongue, and intra-tongue fat). Methods This is a case series analysis of 43 participants of 51 randomized to the surgical arm of the SAMS trial who underwent repeat magnetic resonance imaging (MRI). Upper airway volume, length, and cross-sectional area, soft palate and tongue volumes, and tongue fat were measured. Relationships between changes in anatomical structures and AHI were assessed. Results The participant sample was predominantly male (79%); mean ± SD age 42.7 ± 13.3 years, body mass index 30.8 ± 4.1 kg/m2, and AHI 47.0 ± 22.3 events/hour. There were no, or minor, overall volumetric changes in the airway, soft palate, total tongue, or tongue fat volume. Post-surgery there was an increase in the minimum cross-sectional area by 0.1 cm2 (95% confidence interval 0.04–0.2 cm2) in the pharyngeal airway, but not statistically significant on corrected analysis. There was no association between anatomical changes and AHI improvement. Conclusions This contemporary multilevel upper airway surgery has been shown to be an effective OSA treatment. The current anatomical investigation suggests there are not significant post-operative volumetric changes associated with OSA improvement 6-month post-surgery. This suggests that effect on OSA improvement is achieved without notable deformation of airway volume. Reduced need for neuromuscular compensation during wake following anatomical improvement via surgery could explain the lack of measurable volume change. Further research to understand the mechanisms of action of multilevel surgery is required. Clinical Trial This manuscript presents a planned image analysis of participants randomized to the surgical arm or the clinical trial multilevel airway surgery in patients with moderate-severe obstructive sleep apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=266019&isReview=true%20Australian%20New%20Zealand%20Clinical%20Trials%20Registry%20ACTRN12514000338662, prospectively registered on March 31, 2014.

Objective To assess the 6-month efficacy of uvulopalatopharyngoplasty (UPPP) compared with expectancy in selected patients with obstructive sleep apnoea syndrome (OSAS). Design A prospective single-centre randomised controlled trial with two parallel arms stratified by Friedman stage and body mass index (BMI). Participants 65 consecutive patients with moderate to severe OSAS (apnoea-hypopnoea index (AHI) ≥15 events/h sleep), BMI <36 kg/m2, Epworth sleepiness scale ≥8, Friedman stage I or II. Intervention Surgical treatment with UPPP. The control group underwent UPPP after a delay of 6 months. Outcomes Changes in AHI and other polysomnography parameters at baseline compared with the 6-month follow-up. Results All patients (32 in the intervention group and 33 in the control group) completed the trial. The mean (SD) AHI in the intervention group decreased significantly (p<0.001) by 60% from 53.3 (19.7) events/h to 21.1 (16.7) events/h . In the control group the mean AHI decreased by 11% from 52.6 (21.7) events/h to 46.8 (22.8) events/h, with a significant difference between the groups (p<0.001). The mean time in the supine position and the BMI were unchanged in both groups. Subgroup analyses for Friedman stage, BMI group and tonsil size all showed significant reductions in AHI in the intervention group compared with controls. There were no severe complications after surgery. Conclusions This trial demonstrates the efficacy of UPPP in treating selected patients with OSAS with a mean reduction in AHI of 60% compared with 11% in controls, a highly significant and clinically relevant difference between the groups. Trial registration number NCT01659671.

Abstract Study Objectives To determine in children with obstructive sleep apnea (OSA) the effect of adenotonsillectomy (AT) on the cyclic alternating pattern (CAP) and the relationship between CAP and behavioral, cognitive, and quality-of-life measures. Methods CAP parameters were analyzed in 365 overnight polysomnographic recordings of children with mild-to-moderate OSA enrolled in the Childhood Adenotonsillectomy Trial (CHAT), randomized to either early AT (eAT) or watchful waiting with supportive care (WWSC). We also analyzed CAP in a subgroup of 72 children with moderate OSA (apnea–hypopnea index > 10) that were part of the CHAT sample. Causal mediation analysis was performed to determine the independent effect of changes in CAP on selected outcome measures. Results At baseline, a higher number of A1 phases per hour of sleep was significantly associated with worse behavioral functioning (caregiver Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC): ρ = 0.24, p = 0.042; caregiver Conners’ Rating Scale Global Index: ρ = 0.25, p = 0.036) and lower quality of life (OSA-18: ρ = 0.27, p = 0.022; PedsQL: ρ = −0.29, p = 0.015) in the subgroup of children with moderate OSA, but not across the entire sample. At 7-months follow-up, changes in CAP parameters were comparable between the eAT and WWSC arms. CAP changes did not account for significant proportions of variations in behavioral, cognitive, and quality-of-life performance measures at follow-up. Conclusions We show a significant association between the frequency of slow, high-amplitude waves with behavioral functioning, as well as the quality of life in children with moderate OSA. Early AT in children with mild-to-moderate OSA does not alter the microstructure of nonrapid eye movement sleep compared with watchful waiting after an approximately 7-month period of follow-up. Clinical Trial The study “A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome” was registered at Clinicaltrials.gov (#NCT00560859).

Objectives To compare functional outcomes and complication rates of anterolateral advancement pharyngoplasty (ALA) versus barbed reposition pharyngoplasty (BRP) in the treatment of obstructive sleep apnea patients with palatal and lateral pharyngeal wall collapse. Study design Prospective study. Setting University hospitals. Subjects and methods Forty-six patients were included in this study. Patients were divided into two groups randomly, group 1 (23 cases) underwent anterolateral advancement pharyngoplasty and group 2 (23 cases) underwent barbed relocation pharyngoplasty. According to the following criteria: both sex, age between 18 and 65 years, body mass index ≤ 32 kg/m2, Friedman stage II or III, type I Fujita, nocturnal polysomnography study diagnostic for OSA, retropalatal and lateral pharyngeal wall collapse, diagnosis with flexible nasoendoscopy during a Muller’s maneuver based on a 5-point scale and drug-induced sleep endoscopy. Patients who suffered from retroglossal airway collapse were rolled out. Results Apnea–hypopnea index decreased from 27.50 ± 11.56 to 11.22 ± 7.63 ( P  ≤ .001) in group 1 and from 33.18 ± 10.94 to 12.38 ± 6.77 ( P  ≤ .001) in group 2. Retropalatal posterior airway space increased from 9.84 ± 1.29 mm to 21.48 ± 2.8 mm ( P  ≤ .001) in group 1 and increased from 10.26 ± 1.2 mm to 22.86 ± 2.62 mm ( P  ≤ .001) in group 2. Retropalatal space volume increased from 1.9 ± 0.68 cm 3 to 2.75 ± 0.7 cm 3 ( P  ≤ .001) in group 1 and increased from 1.96 ± 0.88 cm 3 to 2.82 ± 0.83 cm 3 ( P  ≤ .001) in group 2. Surgical success was 86.95% in group 1 compared to 82.6% in group 2. Conclusions Both techniques appear to be effective with a high surgical success rate in the treatment of OSA patients with retropalatal and lateral pharyngeal wall collapse.

Abstract Objectives: The childhood obstructive sleep apnea syndrome (OSAS) is associated with behavioral abnormalities. Studies on the effects of OSAS treatment on behavior are conflicting, with few studies using a randomized design. Further, studies may be confounded by the inclusion of behavioral outcome measures directly related to sleep. The objective of this study was to determine the effect of adenotonsillectomy on behavior in children with OSAS. We hypothesized that surgery would improve behavioral ratings, even when sleep symptom items were excluded from the analysis. Methods: This was a secondary analysis of Child Behavior Checklist (CBCL) data, with and without exclusion of sleep-specific items, from the Childhood Adenotonsillectomy Trial (CHAT). CBCL was completed by caregivers of 380 children (7.0+1.4 [range 5–9] years) with OSAS randomized to early adenotonsillectomy (eAT) versus 7 months of watchful waiting with supportive care (WWSC). Results: There was a high prevalence of behavioral problems at baseline; 16.6% of children had a Total Problems score in the clinically abnormal range. At follow-up, there were significant improvements in Total Problems (p < .001), Internalizing Behaviors (p = .04), Somatic Complaints (p = .01), and Thought Problems (p = .01) in eAT vs. WWSC participants. When specific sleep-related question items were removed from the analysis, eAT showed an overall improvement in Total (p = .02) and Other (p = .01) problems. Black children had less improvement in behavior following eAT than white children, but this difference attenuated when sleep-related items were excluded. Conclusions: This large, randomized trial showed that adenotonsillectomy for OSAS improved parent-rated behavioral problems, even when sleep-specific behavioral issues were excluded from the analysis.

ObjectiveTo investigate the effect of adenotonsillectomy on OSAS symptoms based on a data-driven approach and thereby identify criteria that may help avoid unnecessary surgery in children with OSAS.MethodsIn 323 children enrolled in the Childhood Adenotonsillectomy Trial, randomised to undergo either early adenotonsillectomy (eAT; N = 165) or a strategy of watchful waiting with supportive care (WWSC; N = 158), the apnea-hypopnea index, heart period pattern dynamics, and thoraco-abdominal asynchrony measurements from overnight polysomnography (PSG) were measured. Using machine learning, all children were classified into one of two different clusters based on those features. The cluster transitions between follow-up and baseline PSG were investigated for each to predict those children who recovered spontaneously, following surgery and those who did not benefit from surgery.ResultsThe two clusters showed significant differences in OSAS symptoms, where children assigned in cluster A had fewer physiological and neurophysiological symptoms than cluster B. Whilst the majority of children were assigned to cluster A, those children who underwent surgery were more likely to stay in cluster A after seven months. Those children who were in cluster B at baseline PSG were more likely to have their symptoms reversed via surgery. Children who were assigned to cluster B at both baseline and 7 months after surgery had significantly higher end-tidal carbon dioxide at baseline. Children who spontaneously changed from cluster B to A presented highly problematic ratings in behaviour and emotional regulation at baseline.ConclusionsData-driven analysis demonstrated that AT helps to reverse and to prevent the worsening of the pathophysiological symptoms in children with OSAS. Multiple pathophysiological markers used with machine learning can capture more comprehensive information on childhood OSAS. Children with mild physiological and neurophysiological symptoms could avoid AT, and children who have UAO symptoms post AT may have sleep-related hypoventilation disease which requires further investigation. Furthermore, the findings may help surgeons more accurately predict children on whom they should perform AT.

Obstructive sleep apnea (OSA) is a serious and costly public health problem. The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients. Upper airway reconstructive surgery is available when medical treatments fail but randomized trial evidence supporting its use is limited. This protocol details a randomized controlled trial designed to assess the clinical effectiveness, safety, and cost-effectiveness of a multilevel upper airway surgical procedure for OSA. A prospective, parallel-group, open label, randomized, controlled, multicenter clinical trial in adults with moderate or severe OSA who have failed or refused medical therapies. Six clinical sites in Australia randomly allocated participants in a 1:1 ratio to receive either an upper airway surgical procedure consisting of a modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction, or to continue with ongoing medical management, and followed them for 6 months. Primary outcomes: difference between groups in baseline-adjusted 6 month OSA severity (apnea-hypopnea index) and subjective sleepiness (Epworth Sleepiness Scale). Secondary outcomes: other OSA symptoms (e.g. snoring and objective sleepiness), other polysomnography parameters (e.g. arousal index and 4% oxygen desaturation index), quality of life, 24 hr ambulatory blood pressure, adverse events, and adherence to ongoing medical therapies (medical group). The Sleep Apnea Multilevel Surgery (SAMS) trial is of global public health importance for testing the effectiveness and safety of a multilevel surgical procedure for patients with OSA who have failed medical treatment. Multilevel airway surgery in patients with moderate-severe Obstructive Sleep Apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true Australian New Zealand Clinical Trials Registry ACTRN12614000338662, prospectively registered on 31 March 2014.

Abstract Study Objectives: To describe parental reports of sleepiness and sleep duration in children with polysomnography (PSG)-confirmed obstructive sleep apnea (OSA) randomized to early adenotonsillectomy (eAT) or watchful waiting with supportive care (WWSC) in the ChildHood Adenotonsillectomy Trial (CHAT). We hypothesized children with OSA would have a larger improvement in sleepiness 6 mo following eAT compared to WWSC. Methods: Parents of children aged 5.0–9.9 y completed the Epworth Sleepiness Scale modified for children (mESS) and the Pediatric Sleep Questionnaire-Sleepiness Subscale (PSQ-SS). PSG was performed at baseline and at 7-mo endpoint. Children underwent early adenotonsillectomy or WWSC. Results: The mESS and PSQ-SS classified 24% and 53% of the sample as excessively sleepy, respectively. At baseline, mean mESS score was 7.4 ± 5.0 (SD) and mean PSQ-SS score was 0.44 ± 0.30. Sleepiness scores were higher in African American children; children with shorter sleep duration; older children; and overweight children. At endpoint, mean mESS score decreased by 2.0 ± 4.2 in the eAT group versus 0.3 ± 4.0 in the WWSC group (P < 0.0001); mean PSQ-SS score decreased 0.29 ± 0.40 in eAT versus 0.08 ± 0.40 in the WWSC group (P < 0.0001). Despite higher baseline sleepiness, African American children experienced similar improvement with adenotonsillectomy than other children. Improvement in sleepiness was weakly associated with improved apnea-hypopnea index or oxygen desaturation indices, but not with change in other polysomnographic measures. Conclusions: Sleepiness assessed by parent report was prevalent; improved more after eAT than after WWSC; and was not strongly predicted by sleep disturbances identified by PSG. Clinical Trial Registration: Childhood Adenotonsillectomy Study for Children with OSA (CHAT). ClinicalTrials.gov Identifier #NCT00560859.