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PURPOSE: Our previous randomized controlled trial (RCT) of children with obstructive sleep apnea (OSA) showed no significant differences between adenotonsillectomy (ATE) and adenotonsillomy (ATE) in improving nocturnal respiration and symptoms after one year. This is the continuous report with the evaluation of postoperative morbidity concerning bleeding and pain. METHODS: A double-blinded RCT including 79 children, aged 2-6 years, with moderate to severe OSA, randomized to either ATE (n = 40) or ATT (n = 39). From one to ten days postoperatively, parents filled in a logbook with six pain-related outcomes (parent and child grading pain at different levels, days of analgesic use and return to normal diet). Peri- and postoperative bleeding were also registered. RESULTS: 63 patients (80%) returned the logbook. There were significant differences between groups in only two of the six pain-related outcomes in favor of the ATT group; first day when the children graded themselves as pain free (p = 0.021, Log Rank Test), and first day the caregiver estimated pain VAS ≤ 5 (p = 0.007, Log Rank Test). Two (5%) cases of postoperative bleeding occurred in the ATE group, one of which needed a return to theatre. No case of postoperative bleeding was seen in the ATT group. CONCLUSIONS: The results from this RCT are in line with previous comparative studies between ATT and ATE. Children operated with ATT had significantly less postoperative pain in one-third of the outcomes, and less bleeding than ATE. However, as the differences in morbidity between the surgical methods were minor the clinical significance is uncertain. TRIAL REGISTRATION: This study was approved by the Swedish Regional Ethics Board in Stockholm, Sweden (Dnr 2011/925-32 and 2013/2274-32) and registered at ClinicalTrials.gov (Trial registration number NCT01676181).

Adenotonsillectomy (ATE) is one of the most common surgical procedures to treat children with obstructive sleep apnea (OSA), but to our knowledge there are no randomized clinical trials confirming the benefit of surgery compared with watchful waiting in children between 2 and 4 years of age.To determine whether ATE is more effective than watchful waiting for treating otherwise healthy children with mild to moderate OSA.This randomized clinical trial was conducted from December 2014 to December 2017 at the Otorhinolaryngology Department of the Karolinska University Hospital, Stockholm, Sweden. A total of 60 children, 2 to 4 years of age, with an obstructive apnea-hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to ATE (n = 29) or watchful waiting (n = 31). A total of 53 participants (88%; ATE, n = 25; watchful waiting, n = 28) completed the study. Data were analyzed from August 2018 to December 2018.Adenotonsillectomy.The primary outcome was the difference between the groups in mean OAHI score change. Secondary outcomes were other polysomnography parameters, score on the Obstructive Sleep Apnea-18 (OSA-18) questionnaire, and subgroup analyses. Polysomnography and the OSA-18 questionnaire were completed at baseline and after 6 months.Of the 60 included children, 34 (57%) were boys and the mean (SD) age at first polysomnography was 38 (9) months. Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (-1.0; 95% CI, -2.4 to 0.5), in favor of ATE. However, there were large differences between the groups in favor of ATE regarding the OSA-18 questionnaire (eg, total OSA-18 score: -17; 95% CI, -24 to -10). Also, a subgroup analysis of 24 children with moderate OSA (OAHI ≥5 and10) showed a meaningful difference in mean OAHI score change between the groups in favor of ATE (-3.1; 95% CI, -5.7 to -0.5). Of 28 children, 10 (36%) in the watchful waiting group received ATE after the follow-up, and 7 of these had moderate OSA at baseline.This randomized clinical trial found only small differences between the groups regarding changes in OAHI, but further studies are needed. However, there were large improvements in quality of life after ATE. These results suggest that otherwise healthy children with mild OSA and mild effect on quality of life may benefit from watchful waiting, while children with moderate OSA should be considered for ATE.ClinicalTrials.gov Identifier: NCT02315911.

Purpose In our previous randomized controlled trial (RCT), comparing adenotonsillectomy (ATE) with adenopharyngoplasty (APP) in children with severe obstructive sleep apnea (OSA), there were no differences in respiratory sleep parameters or quality of life. The purpose of the present report was to evaluate postoperative morbidity from this RCT. Methods The study was a blinded RCT in 83 children (ATE = 47; APP = 36), 2–4 years of age, with an obstructive apnea–hypopnea index of ≥ 10. Pain was assessed from the first until the tenth day after surgery with a logbook that reported pain by child (FPS-R, Faces Pain Scale-Revised) and caregiver (visual analogue scale), analgesic use, return to normal diet, and weight change. Bleeding, infection, satisfaction with treatment, speech, and swallowing were assessed with a questionnaire and medical records 6 months after surgery. Results Sixty-four children (77%) returned the logbook and 65 (78%) answered the questionnaire. The median (interquartile range) day the children graded themselves as pain free (FPS-R = 0) was 7 (6–10) after ATE, compared with 9 (7 to > 10) after APP (p = 0.018). There were no other significant differences between the groups regarding any other pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech, but three children (11%) reported impaired speech after APP compared to none after ATE (p = 0.067). Conclusion The results regarding postoperative morbidity were in favor of ATE and the results from our previous report showed no advantages of APP. Therefore, APP should not be recommended in young, otherwise healthy children with OSA.

The objective of this study was to describe factors affecting pain after pediatric tonsil surgery, using patient reported pain-related outcome measures (pain-PROMs) from the National Tonsil Surgery Register in Sweden. In total, 32,225 tonsil surgeries on children (1 to

IMPORTANCE: Adenotonsillectomy (ATE) is the primary surgical method for treating obstructive sleep apnea (OSA) in children. However, children with severe OSA have an increased risk for residual OSA after ATE. Previous studies indicate that adenopharyngoplasty (APP), a modified ATE with closure of the tonsillar pillars, might improve the surgical outcome, but the overall evidence is weak. OBJECTIVE: To determine whether APP is more effective than ATE for treating severe OSA in otherwise healthy children. DESIGN, SETTING, AND PARTICIPANTS: A blinded randomized clinical trial was conducted at the otorhinolaryngology department at Karolinska University Hospital, Stockholm, Sweden. Eighty-three children, aged 2 to 4 years, with an obstructive apnea-hypopnea index (OAHI) score of 10 or higher, were randomized to APP (n = 36) or ATE (n = 47). Participants were recruited from December 1, 2014, through November 31, 2016. INTERVENTIONS: Adenotonsillectomy was performed in all 83 patients in both groups by the cold steel technique. The APP group also underwent closure of the tonsillar pillars with 2 inverted sutures on each side. MAIN OUTCOMES AND MEASURES: The primary outcome was the difference between the groups in OAHI score change before and after surgery. A higher score indicates worse problems and a score of 10 or higher is defined as severe OSA. The outcome was evaluated per protocol and with intention-to-treat analysis. Secondary outcomes were other polysomnography variables and the Obstructive Sleep Apnea-18 (OSA-18) questionnaire (possible total symptom score range, 18-126; higher scores indicate worse quality of life). Polysomnography was performed and the OSA-18 questionnaire was completed preoperatively and 6 months postoperatively. RESULTS: A total of 83 children (49 [59%] boys; mean [SD] age, 36.6 [9.2] months) were included in the study. Of these, 74 (89%) (APP, n = 30; ATE, n = 44) completed the study. The mean (SD) preoperative OAHI score was 23.8 (11.8) for APP and 23.8 (11.5) for ATE. Both the APP and ATE groups had a significant decrease in mean OAHI score after surgery (−21.7; 95% CI, −26.3 to −17.2; and −21.1; 95% CI, −24.5 to −17.7, respectively), but there was no significant difference between the groups (0.7; 95% CI, −4.8 to 6.1). Furthermore, no significant differences between the groups were seen regarding other polysomnography variables (eg, respiratory distress index: mean, 0.6; 95% CI, −5.0 to 6.3) or the OSA-18 questionnaire (eg, total symptom score: −0.5; 95% CI, −13 to 12). One patient from each group was readmitted owing to postoperative bleeding, but no other complications were seen. CONCLUSIONS AND RELEVANCE: This trial did not show that APP was more effective than ATE alone to treat otherwise healthy children with severe OSA. This finding suggests that ATE should continue to be the primary treatment for OSA in children. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02315911

BACKGROUND: Adenotonsillectomy (ATE) is a well-established and effective treatment of pediatric obstructive sleep apnea (OSA). In recent years, a more conservative method, adenotonsillotomy (ATT), has gained popularity because it is associated with less postoperative morbidity. Yet no previous randomized study has compared these 2 methods regarding their effectiveness in treating pediatric OSA in terms of polysomnographic data, which was the primary aim of this study. The hypothesis was that ATT is noninferior to ATE after 1 year. METHODS: Seventy-nine children, aged 2 to 6 years, with OSA (Apnea-Hypopnea Index [AHI] 5–30) were randomized to ATT (n = 40) or ATE (n = 39). Polysomnography (PSG) and questionnaire OSA-18 were assessed at baseline and 1 year postsurgery. RESULTS: Mean difference between groups in the primary outcome, change in AHI, was 0.83, 95% confidence interval –3.2 to 4.9, not exceeding the noninferiority margin of 5. After ATE, AHI decreased from median 12.7 (interquartile range 8.3–19.1) to 2.0 (1.2–3.1) and after ATT from 15.8 (8.5–21.2) to 4.0 (1.2–5.1). For both groups, significant improvements of PSG and OSA-18 questionnaire outcomes were observed, with no significant differences between groups. Five children (13%) in the ATT group needed repeated surgery for tonsil regrowth and recurrence of OSA. CONCLUSIONS: The results suggest that ATT is noninferior to ATE in treating pediatric OSA regarding PSG outcomes after 1 year. ATT could be considered an alternative to ATE for treatment of pediatric OSA. However, after ATT, there is a nonnegligible risk of recurrence of OSA, and this should be taken into account when selecting surgical method.

Objectives The objective of this study was to longitudinally describe the history of tonsil surgery in Swedish children and adolescents regarding incidence, indications for surgery, surgical methods and the age and gender distributions. Setting A retrospective longitudinal population-based cohort study based on register data from the Swedish National Patient Register (NPR) and population data from Statistics Sweden. Participants All Swedish children 1–This study was supported by financial grants from the Acta Otolaryngologica Foundation, the Freemason Child House Foundation in Stockholm and The Health and Medical Care Committee of the Regional Executive Board, Region Vastra Gotaland.

To evaluate the diagnostic value of the quality-of-life instrument OSA-18 by comparing it with objective data from polysomnography in children with sleep-disordered breathing.Cross-sectional.Full-night polysomnographic data were obtained from 225 subjects, 139 boys and 86 girls, median age 4.5 years (1-12) in our sleep laboratory. Their caregivers answered the OSA-18 quality-of-life instrument (range 18-126). The polysomnographic parameter, the apnea-hypopnea index (AHI) was compared with the total symptom score (TSS) and with the subscale of sleep disturbance (SD) from the OSA-18 questionnaire. Receiver operating characteristic (ROC) curves were created to test the predictive value of OSA-18.With the TSS of the OSA-18 at ≥60, compared with AHI levels of1 and ≥5, the sensitivity was 55.2% and 59.3% respectively, and the specificity 40.9% and 48.4%, respectively. With the TSS80 and AHI levels of ≥5 and ≥10, the sensitivity was 24.6% and 32.1%, respectively. For the subscale of SD, the majority of the subjects showed poor correlation with the AHI values. The ROC area under the curve for different levels of the AHI (1, ≥5, and ≥10) was 0.49, 0.57, and 0.56, respectively.The OSA-18 questionnaire showed poor validity in detecting and predicting pediatric OSA. The majority of the children with severe OSA would not be correctly diagnosed if the OSA-18 were used as a dominant diagnostic tool.

The purposes of this study are to investigate the usefulness of polygraphy (PG) in diagnosing obstructive sleep apnea (OSA) in sleepy/tired snorers compared to polysomnography (PSG) and, further, to search for suspected respiratory arousals in the PG. One hundred eighty-seven adults suffering from sleepiness/tiredness and snoring had undergone ambulant PG and were considered to be normal, using American Academy of Sleep Medicine’s 2007 hypopnea criteria A. After approximately 7 months, in-lab PSG was performed using hypopnea criteria B, where arousals are also recognized. Validated questionnaires (Hospital Anxiety and Depression Scale, self-rated general health) were answered. In a subgroup, the sensitivity and specificity were calculated for flow limitation index (FLI) and flattening index (FlatI) in PG compared with the respiratory distress index (RDI) in PSG. Despite the normal PG, at PSG, the median RDI was 11.0 (range, 0–89.1). One hundred sixty-eight out of one hundred seventy-eight (90 %) were found to have at least mild OSA and 119/187 (64 %) with moderate–severe OSA according to the RDI values. The sensitivity and specificity were low (

To compare adherence and treatment effects with an oral appliance (OA) in patients with different types of obstructive sleep apnea (OSA): those with mainly respiratory arousals ("arousers"), and those with oxygen desaturations ("desaturaters") at polysomnography (PSG).A prospective intervention study on 72 "tired snorers" with "normal" home sleep study (HSS), but later diagnosed as OSA with PSG, who accepted OA treatment. They were offered evaluation with a follow-up PSG and questionnaires, including the Epworth Sleepiness Scale (ESS), general health (GH), satisfaction, and side effects.Sixty-six patients, 33 arousers and 33 desaturaters, were adapted to OA. The 1-year adherence rate was significantly higher among arousers (85%) than desaturaters (55%) (p = 0.034). Thirty-six of 66 patients underwent follow-up PSG; the apnea-hypopnea index was significantly reduced in 22 arousers from a median of 14 to 3 (p0.001), and in 14 desaturaters from 18 to 7 (p = 0.002; no significant group difference). ESS and GH showed no significant improvements in either group, although sleepy "arousers" (ESS ≥ 10) significantly improved their ESS. In total, 77% reported side effects, while 63% were still satisfied with the OA treatment. Gender analysis showed a significant dominance of females classified as "arousers" (p = 0.025).OSA patients with mainly arousals at PSG showed higher adherence to OA treatment, compared to patients with desaturations. Both groups responded similarly to treatment: improved nocturnal respiration, but only a small reduction of symptoms. We suggest that "tired snorers" with "normal HSS" should be offered PSG, and if OSA, also OA treatment.

In this prospective intervention study, 33 obese patients with obstructive sleep apnoea syndrome (OSAS) (24 men, 9 women) were consecutively enrolled for a weight reduction program at the Obesity Unit, Karolinska University Hospital. 23 of 33 patients used OSAS-device, 19 with Continuous Positive Airway Pressure and 4 with Mandibular Retaining Device. The patients were investigated with questionnaires, blood tests and ambulant nocturnal polysomnography before and after a 6-month program. Patients with OSAS-device slept without it during the sleep studies. The intervention consisted of 8 weeks low calorie diet and group meetings, followed by a day-care program of behaviour change support.27 of 33 patients (82%, 21 men and 6 women) completed the study. After the intervention there were highly significant decreases (p0.001) in Body Mass Index from mean(S.D.) 40(5) to 34(3), apnoea-hypopnoea index from 43(24) to 26(20) and Epworth Sleepiness Scale (ESS)-score from 9(4) to 6(4). Sleep quality (arousal index, sleep efficiency, percentage deep sleep) and metabolic status (blood pressure, blood glucose levels, lipidemia) were also significantly improved. There was a significant correlation between increased percentage deep sleep and reduced ESS-score. There were no differences due to gender or use/no use of OSAS-device.The results suggest that weight loss, induced by low calorie diet and behaviour change support, significantly improves nocturnal respiratory parameters, sleep quality, daytime sleepiness and metabolic status in obese OSAS patients after 6 months.

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

Conclusions: This follow-up showed a stable and significant decrease in median oxygen desaturation index 4% (ODI(4)) values over the years. Approximately two-thirds of the patients fulfilled the success criteria (ODI4 reduction of 50% and andlt;20) after 15 years. A majority had improved/cured excessive daytime sleepiness (EDS) and were satisfied. No increased mortality rate was seen. Objectives: To evaluate sleep apnoea recordings and symptoms in patients with obstructive sleep apnoea syndrome 15 years after uvulopalatopharyngoplasty (UPPP) compared to baseline and previous follow-ups. Methods: This was a non-randomized, prospective intervention study on 50 patients who underwent UPPP during 1985-88. Their initial median age was 49 years (range 38-71) and ODI4 was 26.5 (4-82). Results: In all, 13 patients had died; 26 patients underwent sleep apnoea recordings. Median ODI4 had decreased from 26.5 (range 4-82) to 8.5 (0-60), p andlt; 0.01, a mean reduction of 52%; 65% of patients achieved the success criteria. One-third was objectively categorized as non-snorers. Median body mass index was unchanged. The questionnaires were answered by 32 of 37 patients; 88% reported improved or cured EDS and 78% were satisfied. Pharyngeal disturbances ratings were low. The standardized mortality rate did not differ from the general Swedish population. Funding Agencies|Swedish Association of Sleep Medicine and Sleep Research||Acta Otolaryngologica Foundation

Randomized controlled pilot study of the effect of weight reduction on nocturnal respiratory parameters in obese patients with obstructive sleep apnoea syndrome (OSAS).Twenty consecutive obese male patients fulfilling OSAS criteria at Karolinska University Hospital were randomized into two groups. Intervention with an 8-week weight reduction programme consisting of a low-calorie diet, together with group meetings, was evaluated compared to expectancy alone for the control group, followed by a crossover. Follow-up at 3 months included anthropometrics and ambulant sleep apnoea recordings.Eleven of twenty men completed the protocol. There were significant differences between the intervention group (n = 6) and the control group (n = 5) in changes of weight (p0.01) and oxygen desaturation index (ODI4) (p0.05). We also found a significant positive correlation in these 11 males after the crossover between their reduction in weight and their reduction in ODI4 (p0.05).This pilot study indicates that weight reduction improves nocturnal respiration in obese OSAS patients after 3 months' dietary treatment compared to expectancy.

To evaluate the prevalence of alcoholism and benzodiazepine abuse among patients with obstructive sleep apnea syndrome (OSAS). Such abuse may aggravate the tendency to apneas, especially in patients with OSAS.The study included 98 consecutive OSAS patients. Two patients dropped out; blood samples could not be obtained from two other patients and a urine sample could not be obtained from one. Blood and urine samples were examined for carbohydrate-deficient transferrin (CDT) and 5-hydroxytryptophol (5-HTOL), markers of excess alcohol intake, and urine-benzodiazepines (u-Benz), a marker of drug abuse. Patients with positive screening tests were offered therapy for their abuse.The CDT test was positive in 8/94 patients (8.5%), the 5-HTOL test in 6/95 (6.3%) and the u-Benz test in 3/95 (3.2%).Our findings correlate well with current views concerning alcohol and drug abuse in Sweden, and do not indicate that the frequency of such abuse is higher among OSAS patients. It should be noted that none of the patients who screened positive in the laboratory tests admitted to being alcohol or drug abusers when they consulted their physician. We recommend screening all OSAS patients for alcohol abuse using not only a questionnaire but also a laboratory test such as the CDT test.

To evaluate the effects of a 2-year weight reduction program on respiratory disturbances, arousal index, daytime sleepiness, metabolic status, and quality of life in obese patients with obstructive sleep apnea syndrome (OSAS).Prospective intervention study of 33 consecutive obese OSAS patients (24 men, 9 women); 19 subjects used continuous positive airway pressure and 4 used mandibular retaining device, except during nights with sleep recording. The program consisted of 8 weeks of low calorie diet followed by group meetings with behavioral change support.Seventy percent of the patients completed the program; 67% completed the sleep recordings. The success rate for the apnea-hypopnea index (AHI) (20 and reductionor = 50%) was 15% in the intention to treat (ITT) analysis. The AHI showed a nonsignificant decrease in mean values, from 43 to 28. The oxygen desaturation index (ODI) decreased from 42 to 23 (p = 0.010), arousal index from 24 to 11 (p = 0.019), body mass index from 40 to 35 (p = 0.003) and the Epworth Sleepiness Scale (ESS) from 9 to 5 (p = 0.026), all ITT. Metabolic status, physical functioning, and vitality evaluations improved only in the per protocol analysis. Reduction in weight correlated significantly to reductions in ESS (p = 0.038) and insulin levels (p = 0.002), respectively. There were no differences based on gender or use/non-use of OSAS treatment device.Our weight reduction program showed a limited success in reducing AHI. However, there were significant improvements in weight, ODI, arousal index, and subjective symptoms. We recommend the program as an adjunct treatment for well-motivated obese OSAS patients.