Response to Hypoglossal Nerve Stimulation Changes With Body Mass Index and Supine Sleep.

Importance: Hypoglossal nerve stimulation (HGNS) is a potential alternative therapy for obstructive sleep apnea (OSA), but its efficacy in a clinical setting and the impact of body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) on treatment response remain unclear. Objective: To investigate whether HGNS therapy is effective for patients with OSA, whether HGNS can treat supine OSA, and whether there are associations between BMI and treatment response. Design, Setting, and Participants: In this cohort study, adult patients with OSA implanted with HGNS at the Washington University Medical Center in St Louis from April 2019 to January 2023 were included. Data were analyzed from January 2023 to January 2024. Exposure: HGNS. Main Outcomes and Measures: Multivariable logistic regression was performed to assess associations between HGNS treatment response and both BMI and supine sleep. Treatment response was defined as 50% reduction or greater in preimplantation Apnea-Hypopnea Index (AHI) score and postimplantation AHI of less than 15 events per hour. Results: Of 76 included patients, 57 (75%) were male, and the median (IQR) age was 61 (51-68) years. A total of 59 patients (78%) achieved a treatment response. There was a clinically meaningful reduction in median (IQR) AHI, from 29.3 (23.1-42.8) events per hour preimplantation to 5.3 (2.6-12.3) events per hour postimplantation (Hodges-Lehman difference of 23.0; 95% CI, 22.6-23.4). In adjusted analyses, patients with BMI of 32 to 35 had 75% lower odds of responding to HGNS compared with those with a BMI of 32 or less (odds ratio, 0.25; 95% CI, 0.07-0.94). Of 44 patients who slept in a supine position, 17 (39%) achieved a treatment response, with a clinically meaningful reduction in median (IQR) supine AHI from 46.3 (33.6-63.2) events per hour preimplantation to 21.8 (4.30-42.6) events per hour postimplantation (Hodges-Lehman difference of 24.6; 95% CI, 23.1-26.5). In adjusted analysis, BMI was associated with lower odds of responding to HGNS with supine AHI treatment response (odds ratio, 0.39; 95% CI, 0.04-2.59), but the imprecision of the estimate prevents making a definitive conclusion. Conclusions and Relevance: This study adds to the growing body of literature supporting the use of HGNS for OSA treatment. Sleep medicine clinicians should consider informing patients that higher BMI and supine sleeping position may decrease therapeutic response to HGNS. Future research is needed to replicate these findings in larger, more diverse cohorts, which would facilitate the optimization of treatment strategies and patient counseling for HGNS therapy.

Hearing Loss-Related Issues Affecting Quality of Life in Preschool Children.

OBJECTIVE: The impact of hearing loss (HL) on quality of life (QOL) in young children has not been examined systematically. The objective of this study was to examine patient, parent, and professional perspectives on experiences and situations that affect the QOL in young children with HL and to identify themes that emerged from coded data to develop a parent-proxy QOL measure for young children with HL. STUDY DESIGN: Qualitative study with 6 focus groups followed by semistructured interviews with other parents and professionals as stakeholder checks. SETTING: Academic medical center and local schools for the deaf. METHODS: Audiology department clinic lists were used to identify eligible participants, who included 5- to 7-year-old children with permanent HL and parents of 2- to 7-year-old children with permanent HL. A sample of 6 children and 12 parents participated in focus groups. An audiology department and multiple schools for the deaf in the area were contacted to recruit for professional participants, resulting in a sample of 10 professionals who participated in focus groups. Focus groups and interviews were audiotaped and transcribed verbatim. Inductive thematic analysis of focus group transcripts identified key concepts and emerging themes of how HL affects young children. RESULTS: Six themes emerged from the data: behavior, feelings, environments, social/activities, family, and hearing equipment. Child, parent, and professional focus group themes overlapped well, and data saturation was reached. CONCLUSION: These qualitative data provided insight into HL-related issues affecting young children's QOL and were used to create items for a new parent-proxy QOL questionnaire.

Predictors of Occurrence and Timing of Post-Tonsillectomy Hemorrhage: A Case-Control Study.

OBJECTIVE: To describe cases and timing of pediatric post-tonsillectomy hemorrhage (PTH), to evaluate predictors of PTH, and to determine the optimal amount of postoperative care unit (PACU) monitoring time. STUDY DESIGN: Using the Pediatric Health Information System (PHIS) database and electronic medical records, a matched case-control study from 2005 to 2015 was performed. SETTING: A single, tertiary-care institution. SUBJECTS AND METHODS: Each case of PTH was matched with 1 to 4 controls for the following factors: age, sex, surgeon, and time of year. A total of 124 cases of PTH and 479 tonsillectomy controls were included. The rate and timing of postoperative bleeding were assessed, and matched pair analysis was performed using conditional logistic regression. RESULTS: Our institutional PTH rate of 1.9% (130 of 6949) included 124 patients; 15% (19) were primary (≤24 hours), with 50% (9) occurring within 5 hours. Twenty-one percent (4 of 19) of primary PTH patients received operative intervention. Eighty-five percent (105 of 124) of all cases were secondary PTH, and 47% (49) of those patients received operative intervention. Cold steel (OR 1.9, 95% CI 1.1-3.3) and Coblation (OR 1.9, 95% CI 1.2-3.1) techniques and tonsillectomy alone (OR 3.7, 95% CI 1.9-7.2) increased odds of PTH. Patients who developed PTH had 4 times the odds of having a preceding postoperative respiratory event than controls (OR 4.0, 95% CI 1.6-10.0). CONCLUSION: We conducted a rigorous case-control study for PTH, finding that PTH was associated with use of cold steel and Coblation techniques and with tonsillectomy alone. Patients with a postoperative respiratory event may be more likely to develop a PTH and should be counseled accordingly. A PACU monitoring time of 4 hours is sufficient for outpatient tonsillectomy.

Effect of Perioperative Gabapentin Use on Postsurgical Pain in Patients Undergoing Head and Neck Mucosal Surgery: A Randomized Clinical Trial.

Importance: Effective postoperative pain management increases patient satisfaction, reduces cost, reduces morbidity, and shortens hospitalizations. Previous studies investigating multimodal pain therapy in otolaryngology patients focused on homogenous patient groups with short postoperative follow-up times. Objective: To investigate the effect of perioperative gabapentin treatment on postsurgical pain in patients undergoing head and neck mucosal surgery. Design, Setting, and Participants: Adults undergoing head and neck mucosal surgery from July 25, 2016, through June 19, 2017, were included in this double-blinded, placebo-controlled randomized clinical trial and randomized to receive gabapentin, 300 mg twice daily, or placebo before surgery and up to 72 hours after surgery. Main Outcomes and Measures: Primary outcome was hourly narcotic use calculated in morphine equivalents. Secondary outcomes included subjective visual analog scale pain scores captured for resting, coughing, and swallowing using a 0- to 100-mm scale (a 100-mm line anchored with no pain on the left end and worst possible pain on the right end). A change of 10 mm or more was deemed to be clinically meaningful. Additional secondary outcome measures included degree of pain control, patient satisfaction, and adverse effects. Results: Of the 110 patients randomized to receive gabapentin or placebo, 11 and 10 withdrew from each group, respectively. Ninety patients were then analyzed: 44 in the gabapentin group (mean [SD] age, 61.1 [10.0] years; 33 [75%] male; 40 [91%] white) and 46 in the placebo group (mean [SD] age, 60.9 [11.3] years; 35 [78%] male; 43 [94%] white). Both groups had similar self-reported levels of preoperative pain and narcotic effectiveness. A median difference of 0.26 mg/h of morphine (95% CI, -0.27 to 0.94 mg/h) was found between groups. After controlling for comorbidity and self-reported baseline pain levels, mixed model analysis found the difference in marginal means of visual analog scale scores between groups to be lower in the gabapentin group compared with the placebo group for all categories (rest difference, 7.9 mm; 95% CI, -0.4 to 16.2 mm; cough difference, 8.9 mm; 95% CI, -0.5 to 18.3 mm; swallow difference, 9.4 mm; 95% CI, -1.2 to 20.0 mm). More patients in the gabapentin group reported that pain was always well controlled than in the placebo group (difference, 9.2%; 95% CI, -21% to 3%). Gabapentin and placebo groups reported similar levels of satisfaction with pain control (difference, 2%; 95% CI, -11% to 15%). There was no clinically meaningful difference in reported nausea between the 2 groups (difference, 6%; 95% CI, -14% to 26%). Conclusion and Relevance: Perioperative gabapentin given 300 mg twice daily did not result in reduced narcotic use, but results were compatible with clinically meaningful reductions in pain scores. Satisfaction with pain control and adverse effects were similar between groups. Trial Registration: ClinicalTrials.gov Identifier: NCT02926573.

Utility of Serum Biomarkers in the Diagnosis and Stratification of Mild Traumatic Brain Injury.

OBJECTIVE: The objective was to compare test characteristics of a single serum concentration of glial fibrillary acidic protein (GFAP), S-100ß, and ubiquitin carboxyl terminal hydrolase L1 (UCH-L1), obtained within 6 hours of head injury, to diagnose mild traumatic brain injury (mTBI) in head-injured subjects. METHODS: Adults aged 18 to 80 years who presented to one of seven EDs with a blunt closed head injury underwent head CT within 4 hours of injury and had blood drawn for biomarker analysis within 6 hours of injury were eligible. Subjects were considered to have mTBI if they had an initial Glasgow Coma Scale (GCS) > 13 and met one or more of the following criteria: loss of consciousness (LOC), posttraumatic amnesia, or confusion. Subjects with mTBI and an abnormal head computed tomography (CT) scan were categorized as complicated mTBI; those with a normal head CT were categorized as uncomplicated mTBI; and subjects with a GCS = 15, no LOC, no posttraumatic amnesia, and no confusion were considered to not have a mTBI. Biomarker concentration measurements for GFAP and UCH-L1 were performed using an enzyme-linked immunosorbent assay. S-100ß concentration was determined using an electrochemiluminescence immunoassay. Median biomarker concentration for each group was compared using the Kruskal-Wallis test. Logistic regression was used to determine area under the receiver operating curve (AUC) for each of the three biomarkers. Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and negative and positive likelihood ratios (LRs) for the three biomarkers to differentiate between complicated mTBI, uncomplicated mTBI, and no mTBI were calculated. RESULTS: A total of 247 subjects were enrolled and had adequate clinical and biomarker information for analysis. A total of 188 met criteria for mTBI, with 34 (18.1%) having an acute abnormality on CT (complicated mTBI). The mean (±SD) age of the study population was 45.8 (±17.3) years, and 59.9% were male. Median serum concentrations for all biomarkers were significantly different between groups, lowest in the no mTBI group, and progressively increasing in the uncomplicated and complicated mTBI groups (p < 0.0001). All three biomarkers were significant classifiers of mTBI versus no mTBI, with the following AUCs: GFAP, 0.70; S-100ß, 0.69; and UCH-L1, 0.65 (p = 0.17). Sensitivity for mTBI was highest for S-100ß (96.5%). NPVs ranged from 31% for UCH-L1 to 35% for GFAP. PPVs ranged from 75.5% for S-100ß to 96.5% for GFAP. Negative LR ranged from 0.59 for GFAP to 0.71 for UCH-L1, with positive LR ranging from 1.0 for both UCH-L1 and S-100ß to 8.7 for GFAP. CONCLUSION: A single serum concentration of GFAP, UCH-L1, or S-100ß within 6 hours of head injury may be useful in identifying and stratifying the severity of brain injury in emergency department patients with head trauma, but cannot reliably exclude a diagnosis of concussion. A positive GFAP was associated with the presence of concussion.