Dataset Information

Changes in obstructive sleep apnea severity, biomarkers, and quality of life after multilevel surgery.

ABSTRACT:

Objectives/hypothesis

To evaluate the impact of multilevel obstructive sleep apnea surgical treatment on sleep-disordered breathing severity, health-related measures, and quality of life, and to examine the association between changes in sleep-disordered breathing severity and these other outcomes.

Study design

Prospective cohort study.

Methods

Subjects with obstructive sleep apnea unable to tolerate positive airway pressure therapy and with evidence of multilevel (palate and hypopharynx) obstruction underwent uvulopalatopharyngoplasty, tonsillectomy, and genioglossus advancement, with or without hyoid suspension. All subjects had preoperative and postoperative study assessments, including blood draw for C-reactive protein, interleukin-6, homocysteine, homeostasis model of insulin resistance, and leptin, and evaluation with the Functional Outcomes of Sleep Questionnaire.

Results

Thirty subjects underwent multilevel surgical treatment. The mean apnea-hypopnea index decreased from 44.9 +/- 28.1 to 27.8 +/- 26.4 events/hour (P = .008). Thirteen (43%) subjects in this heterogeneous sample achieved a response to surgery (defined as an apnea-hypopnea index reduction of >or=50% to an absolute level <15 events/hour), and body mass index ConclusionsThis multilevel surgery was associated with a low likelihood of response in subjects with body mass index >32 kg/m(2). Responders had decreased C-reactive protein levels that were independent of changes in body weight.

SUBMITTER: Kezirian EJ

PROVIDER: S-EPMC5496819 | biostudies-literature | 2010 Jul

REPOSITORIES: biostudies-literature

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Publications

Changes in obstructive sleep apnea severity, biomarkers, and quality of life after multilevel surgery.

Kezirian Eric J EJ Malhotra Atul A Goldberg Andrew N AN White David P DP

The Laryngoscope 20100701 7

<h4>Objectives/hypothesis</h4>To evaluate the impact of multilevel obstructive sleep apnea surgical treatment on sleep-disordered breathing severity, health-related measures, and quality of life, and to examine the association between changes in sleep-disordered breathing severity and these other outcomes.<h4>Study design</h4>Prospective cohort study.<h4>Methods</h4>Subjects with obstructive sleep apnea unable to tolerate positive airway pressure therapy and with evidence of multilevel (palate a ...[more]

PMID: 20564750

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Project description:Background and objectivesData from a randomized, controlled study of adenotonsillectomy for obstructive sleep apnea syndrome (OSAS) were used to test the hypothesis that children undergoing surgery had greater quality of life (QoL) and symptom improvement than control subjects. The objectives were to compare changes in validated QoL and symptom measurements among children randomized to undergo adenotonsillectomy or watchful waiting; to determine whether race, weight, or baseline OSAS severity influenced changes in QoL and symptoms; and to evaluate associations between changes in QoL or symptoms and OSAS severity.MethodsChildren aged 5 to 9.9 years with OSAS (N = 453) were randomly assigned to undergo adenotonsillectomy or watchful waiting with supportive care. Polysomnography, the Pediatric Quality of Life inventory, the Sleep-Related Breathing Scale of the Pediatric Sleep Questionnaire, the 18-item Obstructive Sleep Apnea QoL instrument, and the modified Epworth Sleepiness Scale were completed at baseline and 7 months. Changes in the QoL and symptom surveys were compared between arms. Effect modification according to race and obesity and associations between changes in polysomnographic measures and QoL or symptoms were examined.ResultsGreater improvements in most QoL and symptom severity measurements were observed in children randomized to undergo adenotonsillectomy, including the parent-completed Pediatric Quality of Life inventory (effect size [ES]: 0.37), the 18-item Obstructive Sleep Apnea QoL instrument (ES: -0.93), the modified Epworth Sleepiness Scale score (ES: -0.42), and the Sleep-Related Breathing Scale of the Pediatric Sleep Questionnaire (ES: -1.35). Effect modification was not observed by obesity or baseline severity but was noted for race in some symptom measures. Improvements in OSAS severity explained only a small portion of the observed changes.ConclusionsAdenotonsillectomy compared with watchful waiting resulted in significantly more improvements in parent-rated generic and OSAS-specific QoL measures and OSAS symptoms.

Project description: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.

Project description:Study objectivesThere is uncertainty over which characteristics increase obstructive sleep apnea syndrome (OSAS) severity in children. In candidates for adenotonsillectomy (AT), we evaluated the relationship of OSAS severity and age, sex, race, body mass index (BMI), environmental tobacco smoke (ETS), prematurity, socioeconomic variables, and comorbidities.DesignCross-sectional screening and baseline data were analyzed from the Childhood Adenotonsillectomy Trial, a randomized, controlled, multicenter study evaluating AT versus medical management. Regression analysis assessed the relationship between the apnea hypopnea index (AHI) and risk factors obtained by direct measurement or questionnaire.SettingClinical referral setting.ParticipantsChildren, ages 5 to 9.9 y with OSAS.Measurements and resultsOf the 1,244 children undergoing screening polysomnography, 464 (37%) were eligible (2 ≤ AHI < 30 or 1 ≤ obstructive apnea index [OAI] < 20 and without severe oxygen desaturation) and randomized; 129 (10%) were eligible but were not randomized; 608 (49%) had AHI/OAI levels below entry criteria; and 43 (3%) had levels of OSAS that exceeded entry criteria. Among the randomized children, univariate analyses showed significant associations of AHI with race, BMI z score, environmental tobacco smoke (ETS), family income, and referral source, but not with other variables. After adjusting for potential confounders, African American race (P = 0.003) and ETS (P = 0.026) were each associated with an approximately 20% increase in AHI. After adjusting for these factors, obesity and other factors were not significant.ConclusionsApnea hypopnea index level was significantly associated with race and environmental tobacco smoke, highlighting the potential effect of environmental factors, and possibly genetic factors, on pediatric obstructive sleep apnea syndrome severity. Efforts to reduce environmental tobacco smoke exposure may help reduce obstructive sleep apnea syndrome severity.Clinical trial registrationClinicaltrials.gov (#NCT00560859).

Dataset Information

Changes in obstructive sleep apnea severity, biomarkers, and quality of life after multilevel surgery.

Objectives/hypothesis

Study design

Methods

Results

Publications

Changes in obstructive sleep apnea severity, biomarkers, and quality of life after multilevel surgery.

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