Dutasteride Improves Nocturia but Does Not Lead to Better Sleep: Results from the REDUCE Clinical Trial.

PURPOSE: In men, complaints of nocturia causing poor sleep are often attributed to benign prostatic hyperplasia and treated with benign prostatic hyperplasia medications. We assessed whether treating lower urinary tract symptoms with dutasteride altered either nocturia or sleep quality using data from REDUCE. MATERIALS AND METHODS: REDUCE was a 4-year randomized, multicenter trial comparing dutasteride 0.5 mg/day vs placebo for prostate cancer chemoprevention. Study participants were men considered at increased risk for prostate cancer. Eligibility included age 50-75 years, prostate specific antigen 2.5-10 ng/ml, and 1 negative prostate biopsy. At baseline, 2 years and 4 years, men completed the International Prostate Symptom Score and Medical Outcomes Study Sleep Scale, a 6-item scale assessing sleep. To test differences in nocturia and Medical Outcomes Study Sleep Scale over time, we used linear mixed models adjusted for baseline confounders. Subanalyses were conducted in men symptomatic from lower urinary tract symptoms, nocturia, poor sleep, or combinations thereof. RESULTS: Of 6,914 men with complete baseline data, 80% and 59% were assessed at 2 and 4-year followup, respectively. Baseline characteristics were balanced between treatment arms. Dutasteride improved nocturia at 2 (-0.15, 95% CI -0.21, -0.09) and 4 years (-0.24, 95% CI -0.31, -0.18) but did not improve sleep. When limited to men symptomatic from lower urinary tract symptoms, nocturia, poor sleep or combinations thereof, results mirrored findings from the full cohort. CONCLUSIONS: In men with poor sleep who complain of nocturia, treatment of lower urinary tract symptoms with dutasteride modestly improves nocturia but has no effect on sleep. These results suggest men with poor sleep who complain of nocturia may not benefit from oral benign prostatic hyperplasia treatment.

Partial Validation of the Sleep Health Construct in the Medical Outcomes Study Sleep Questionnaire.

Sleep health is postulated as a multi-dimensional construct comprised of sleepiness/alertness, timing, duration, efficiency, and satisfaction. New questionnaires for its measurement have been proposed. We performed secondary data analyses and analyzed responses on a widely used, well-established sleep questionnaire to determine whether the construct might be detectable with an existing questionnaire. Healthy men (n = 7604) aged 55-75 completed the six-item Medical Outcomes Study Sleep Questionnaire (MOSSQ) at baseline in a large, randomized clinical trial [the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial). Two components clearly emerged from a Principal Components Analysis, suggesting that both sleep disturbance and sleep satisfaction are differentiated by the MOSSQ. Selected elements of sleep health are accessible with relatively few questionnaire items. Widespread previous usage of the MOSSQ in both descriptive and interventional research suggests that many previously collected databases could address at least two components of this construct.

Sleep quality and prostate cancer aggressiveness: Results from the REDUCE trial.

BACKGROUND: Disrupted sleep has been associated with increased risk of certain cancers. Little data exist in prostate cancer. We tested the association between sleep quality and prostate cancer diagnosis overall and by tumor grade in the Reduction by Dutasteride of Prostate Cancer Events chemoprevention trial. We hypothesized that worse sleep quality would be associated with increased tumor aggressiveness. METHODS: At baseline, 5614 men completed a validated six-item questionnaire on sleep quality. We generated a composite score categorized into tertiles to measure overall sleep quality and assessed each sleep quality question individually. Logistic regression was used to test associations between baseline sleep quality and overall, low-grade and high-grade prostate cancer diagnosis at 2-year study-mandated biopsy. Models were stratified by nocturia. RESULTS: Overall sleep quality was unrelated to overall or low-grade prostate cancer. Worse overall sleep quality was associated with elevated odds of high-grade prostate cancer (odds ratio [OR]T3vsT1 1.15; 95% confidence interval [CI]: 0.83-1.60 and ORT2vsT1 1.39; 95% CI: 1.01-1.92). Men reporting trouble falling asleep at night sometimes vs never had elevated odds of high-grade prostate cancer (OR: 1.51; 95% CI: 1.08-2.09) while trouble staying awake during the day was associated with decreased odds of low-grade prostate cancer (OR: 0.65; 95% CI: 0.49-0.86). Results were similar within strata of nocturia severity. CONCLUSIONS: Overall, associations between sleep quality and prostate cancer were inconsistent. However, there was some evidence for a positive association between insomnia and high-grade prostate cancer, and an inverse relationship between daytime sleepiness and low-grade prostate cancer; findings that should be validated by future studies.

Patient satisfaction survey experience among American otolaryngologists.

BACKGROUND: Patient Satisfaction (PS) is a commonly used metric in health care settings to assess the quality of care given by physicians. Monitoring physicians in this way may impact physician quality of life. Studies evaluating this impact are not available. This study sought to examine the physician experience of measuring PS among practicing otolaryngologists. METHODS: Using an online survey platform, a 34-item survey was given to practicing otolaryngologists through email distribution. The survey included questions about physician, practice and patient demographics, as well as inquiries regarding the way in which PS was measured and how it affected physician work and personal life. Data from these questions were reviewed and analyzed. RESULTS: 174 otolaryngologists responded to the survey. A majority of physicians' (55.3%) PS scores had been tracked with 89.9% reporting being tracked for a length of at least 1 year. PS scores for individual physicians were noted to be inconsistent and vary significantly between reports. Measuring patient satisfaction led to increased occupational stress, yet most physicians (63.8%) felt the monitoring did not lead to improvements in their practice. Some physicians (36.2%) reported that the collection of patient satisfaction scores had negatively influenced the way they practiced medicine, including the pressure to order superfluous tests or to prescribe unnecessary medications. CONCLUSION: Overall, physicians are negatively affected by the tracking of patient satisfaction scores. Occupational stress caused by the collection of patient satisfaction scores may contribute to physician burnout.

Sleep Problems are Associated with Development and Progression of Lower Urinary Tract Symptoms: Results from REDUCE.

PURPOSE: Although lower urinary tract symptoms and sleep problems often develop together, to our knowledge it is unknown whether sleep disturbances are linked to lower urinary tract symptoms development and progression. As measured by the 6-item MOS-Sleep (Medical Outcomes Study Sleep Scale) survey we examined the relationship between sleep problems, and the development and progression of lower urinary tract symptoms in the REDUCE (Reduction by Dutasteride of Prostate Cancer Events) study. MATERIALS AND METHODS: REDUCE was a randomized trial testing prostate cancer chemoprevention with dutasteride in men with prostate specific antigen 2.5 to 10 ng/ml and a negative biopsy. At baseline men completed MOS-Sleep and a scaled average was used to calculate the sleep score. Men were followed for 4 years and I-PSS (International Prostate Symptom Score) was completed at baseline and every 6 months. Asymptomatic men had I-PSS less than 8 while symptomatic men had I-PSS 8 or greater. In the placebo arm of 2,588 men not receiving α-blockers or 5α-reductase inhibitors at baseline we tested the association between sleep problems and lower urinary tract symptom development and progression using Cox models. RESULTS: During followup lower urinary tract symptoms developed in 209 of 1,452 asymptomatic men (14%) and 580 of 1,136 (51%) with lower urinary tract symptoms demonstrated progression. On multivariable analysis higher sleep scores were suggestively associated with increased lower urinary tract symptoms in asymptomatic men (quartile 4 vs 1 HR 1.41, 95% CI 0.92-2.17, p = 0.12) and with lower urinary tract symptom progression in symptomatic men (per 10 points of sleep score HR 1.06, 95% CI 1.01-1.12, p = 0.029). CONCLUSIONS: Among men with lower urinary tract symptoms worse sleep scores were associated with the progression of lower urinary tract symptoms and among asymptomatic men worse sleep scores were suggestively associated with the development of lower urinary tract symptoms. If confirmed, these data suggest that sleep problems may precede such symptoms. Whether treating sleep problems would improve lower urinary tract symptoms requires further testing.

Early diagnosis and successful management of oral mucormycosis in a hematopoietic stem cell transplant recipient: case report and literature review.

PURPOSE: Oral mucormycosis is a rare and high risk of infection in patients following hematopoietic cell transplantation few cases in the literature. We review the literature and present an additional case to emphasize the subtle changes that resulted in positive outcome when diagnosed and managed in a comprehensive transplant team. RESULTS: A patient was diagnosed with gingival mucormycosis on day +25 following a hematopoietic stem cell transplant for lymphoblastic transformation of chronic myeloid leukemia. The patient was diagnosed with minor and nonspecific symptoms and was successfully treated with local dental extraction, a short course of liposomal amphotericin B and 4 months of oral posaconazole. CONCLUSIONS: The good outcome of this case highlights the subtle clinical changes that present early in mucormycosis and the importance of early detection and treatment of post-transplant oral infections by an experienced multidisciplinary team.

Laryngeal Manifestations of the Human Monkeypox Virus.

An HIV+ patient presented with human monkeypox and ENT was consulted to rule out a deep neck abscess. Flexible nasopharyngolaryngoscopy showed severe laryngeal edema and new findings consistent with laryngeal HMPX. The patient was monitored for a potential difficult airway situation, started on appropriate treatment, and showed symptom resolution. Laryngoscope, 134:1340-1342, 2024.

Gender-Specific Differences in Preoperative Concerns in Patients Undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis.

OBJECTIVES: Among patients with chronic rhinosinusitis (CRS), gender differences in epidemiology as well as quality of life have been reported. However, whether gender differences in endoscopic sinus surgery (ESS) preoperative concerns exist is unclear. METHODS: CRS patients undergoing ESS at 3 tertiary care centers in Los Angeles completed the validated Western Surgical Concern Inventory - ESS assessing ESS preoperative concerns. RESULTS: Of the 75 patients included, female patients expressed greater concern than male patients in regard to nasal packing, undergoing anesthesia, impact of surgery on daily activities, and pain and discomfort following surgery. CONCLUSION: This study suggests there are gender differences in ESS preoperative concerns and otolaryngologists should be aware of these possible concerns during preoperative discussions.

The Influence of Modifiable Risk Factors on Postoperative Outcomes in Patients Receiving Surgery for Resection for Acoustic Neuroma.

Acoustic neuromas are the most common tumor of the cerebellopontine angle that are associated with a number of symptoms that negatively impact a patient's quality of life. While the mainstay of treatment for these benign tumors remains microsurgical resection, there is limited research exploring how certain modifiable risk factors (MRFs) may affect the perioperative course. The purpose of this study was to investigate how MRFs including malnutrition, obesity, dyslipidemia, uncontrolled hypertension, and smoking may affect postoperative rates of readmission and nonroutine discharges. We utilized the 2016 and 2017 Healthcare Cost and Utilization Project Nationwide Readmissions Database. MRFs were queried using appropriate International Classification of Diseases, Tenth Revision (ICD-10) coding for categories including malnutrition, obesity, dyslipidemia, smoking, alcohol, and hypertension. The statistical analysis was done using RStudio (Version 1.3.959). Chi-squared tests were done to evaluate differences between categorical variables. The Mann-Whitney U-testing was utilized to evaluate for statistically significant differences in continuous data. The "Epitools" package was used to develop logistic regression models for postoperative complications and post hoc receiver operating characteristic curves were developed. Pertaining to nonroutine discharge, predictive models using malnutrition outperformed all other MRFs as well as those with no MRFs (P < .05). In the case of readmission, models using malnutrition outperformed those of obesity and smoking (P < .05). Again, an increase in predictive power is seen in models using dyslipidemia when compared to obesity, smoking, or uncontrolled hypertension. Lastly, models using no MRFs outperformed those of obesity, smoking, and uncontrolled hypertension (P < .05). This is the first study of its kind to evaluate the role of MRFs in those undergoing surgical resection of their acoustic neuroma. We concluded that certain MRFs may play a role in complicating a patient's perioperative surgical course.

Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial.

Importance: Evidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA). Objective: To evaluate the safety and effectiveness of targeted hypoglossal nerve stimulation (THN) of the proximal hypoglossal nerve in patients with OSA. Design, Setting, and Participants: This randomized clinical trial (THN3) was conducted at 20 centers and included 138 patients with moderate to severe OSA with an apnea-hypopnea index (AHI) of 20 to 65 events per hour and body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or less. The trial was conducted from May 2015 through June 2018. Data were analyzed from January 2022 through January 2023. Intervention: Implant with THN system; randomized 2:1 to activation at month 1 (treatment) or month 4 (control). All received 11 months of THN with follow-up at months 12 and 15, respectively. Main Outcomes and Measures: Primary effectiveness end points comprised AHI and oxygen desaturation index (ODI) responder rates (RRs). Treatment responses at months 4 and 12/15 were defined as a 50% or greater reduction in AHI to 20 or less per hour and an ODI decrease of 25% or greater. Coprimary end points comprised (1) month 4 AHI and ODI RR in the treatment greater than the control group and (2) month 12/15 AHI and ODI RR in the entire cohort exceeding 50%. Secondary end points included sleep apnea severity (AHI and ODI) and patient-reported outcomes (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale). Results: Among 138 participants, the mean (SD) age was 56 (9) years, and 19 (13.8%) were women. Month 4 THN RRs were substantially greater in those in the treatment vs control group (AHI, 52.3% vs 19.6%; ODI, 62.5% vs 41.3%, respectively) with treatment-control standardized mean differences of 0.725 (95% CI, 0.360-1.163) and 0.434 (95% CI, 0.070-0.843) for AHI and ODI RRs, respectively. Months 12/15 RRs were 42.5% and 60.4% for AHI and ODI, respectively. Improvements in AHI, ODI, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale scores were all clinically meaningful (medium to large effect size). Two serious adverse events and 100 nonserious related adverse events were observed from the implant procedure or study protocol. Conclusions and Relevance: This randomized clinical trial found that THN demonstrated improvements in sleep apnea, sleepiness, and quality of life in patients with OSAs over an extended AHI and body mass index range without prior knowledge of pharyngeal collapse pattern. Clinically meaningful improvements in AHI and patient-reported responses compared favorably with those of distal hypoglossal nerve stimulation trials, although clinically meaningful differences were not definitive for ODI. Trial Registration: ClinicalTrials.gov Identifier: NCT02263859.

Analysis of readmissions data among frail and non-frail patients presenting for acoustic neuroma.

The incidence of acoustic neuromas in the United States is 1.09 per 100,000 with 23,739 newly diagnosed cases in the years 2004 to 2010. Because the recent literature has supported that frailty can serve as a more accurate predictor of patient outcomes when evaluated with age, and is an important variable to consider in the course of patient treatment. The objective of this study was to compare the outcomes of frail patients who had undergone surgery for acoustic neuroma with their non-frail counterparts.The authors conducted a retrospective cohort study of geriatric patients receiving cranial neurosurgery for acoustic neuroma between 2016 and 2017 by using the Nationwide Readmission Database. A total of 396 frail patients and 402 non-frail patients were identified through the database of undergoing surgery for acoustic neuroma. Frail patients had statistically higher rates of readmission (p < 0.01), post-operative infection (p < 0.01), facial paralysis (p < 0.01), urinary tract infection (p < 0.01), hydrocephalus (p < 0.01), and dysphagia (p < 0.01). These post-op morbidities likely led to the increased length of stay (p < 0.01), non-routine discharge (p < 0.01), and all payer cost seen in frail patients (p < 0.01). However, no significant difference was found between frail and non-frail patients with regards to CSF leak, post hemorrhagic anemia, myocardial infarction, and mortality. Patient frailty status is a significant predictor of poor outcomes in the postoperative sequelae of acoustic neuroma surgery. Further, models including patient frailty plus age outperformed those using age alone for prediction of several postoperative complications.

Ewing Sarcoma of the Ethmoid Sinus in an Adult.

Extraskeletal Ewing sarcoma (EES) is a relatively rare primary tumor of the soft tissues predominantly affecting men in the second and third decades of life. They are a less common form of the cancerous growth known as an Ewing sarcoma, which occurs in bones or soft tissue such as cartilage. Head and neck ESS can require intervention including endoscopic sinus surgery, septoplasty, inferior turbinectomy, and left internal nasal valve repairs with septal cartilage This is a case report on an unusual presentation of ESS in the sinonasal region.

Trapezius fasciocutaneous flap for burn reconstruction.

This case involves a 30-year-old female who suffered extensive facial burns as an outcome of a horrific assault. The patient subsequently underwent 2 surgeries with the ultimate goal of reducing the cosmetic, physical, and thus mental burden the assault caused. The technique of choice was the novel trapezius fasciocutaneous flap for burn reconstruction of the neck. It is discussed that while this technique is still deemed a novel procedure, its unique characteristics make it an excellent choice for cases similar to this one. While this approach has not been widely popularized in the treatment of patients with burn contracture requiring reconstruction, the donor site characteristics and ideal functionality make the trapezius fasciocutaneous flap such an excellent choice. This particular type of graft yields a hidden donor site, contains rich vascularity with physical qualities similar to those of facial skin, specifically in regard to thickness, color, and texture, and ultimately produces the most ideal cometic outcome. Further, the wide arc of rotation unique to this flap allows for better manipulation and mobility at the transplanted location. While the anatomic implications are very relevant to head and neck surgery, this method also produces exemplary cosmetic outcomes when compared to other graft procedures.

Evaluating the Efficacy and Trend of Sinus Surgery.

Introduction From April 2009 to December 2016, 661 consecutive patients undergoing sinus surgery completed a quality of life (QOL) questionnaire (SNOT-22) preoperatively and at 3, 6, and 12 months postoperatively. Objective (1) To evaluate the long-term efficacy of sinus surgery using QOL instruments. (2) To determine the optimal evaluation time for surgical efficacy. (3) To determine if surgical results improve with yearly experience. Methods The prospective study patients were split into two groups: Group A, those who completed the initial preoperative evaluation and all postoperative evaluations, and Group B, who completed the preoperative questionnaire and at least one but not all of the postoperative questionnaires. Group A included 93 patients. Group B included 240 patients at 3 months, 180 at 6 months, and 121 at 12 months postoperatively. Results Group A efficacy reported at 3 months was 82.8%, 80.6% at 6 months, and 84.9% at 12 months postoperatively. Group B efficacy reported at 3 months was 71.3%, 78.3% at 6 months, and 84.3% at 12 months postoperatively. An 8-year trend analysis of year-to-year 12 months postoperative data illustrates a significant improvement with an analysis of variance (ANOVA) linear rate of 1.594 ( p ≤0.12). Conclusion The 8-year trend at 12 months postoperatively shows a positive improvement in surgical results. Patients undergoing sinus surgery at tertiary medical center showed 84.9% improvement in sinus disease symptoms by 12 months postoperatively. Long-term improvement analysis showed no difference between 6 months postoperatively and 12 months, signifying 6 months as an effective evaluation for surgical efficacy.

Eustachian Tube Quality of Life and Severity of Disease in Patients With Chronic Rhinosinusitis.

BACKGROUND: Chronic rhinosinusitis (CRS) has long been a suspected risk factor for Eustachian tube dysfunction (ETD). However, there have been few studies quantifying the presence of ETD in CRS patients. We sought to determine the prevalence of ETD symptoms in patients undergoing functional endoscopic sinus surgery (FESS) for CRS using the validated 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) and to correlate the ETDQ-7 scores with scores of CRS symptom severity based on the 22-item Sino-Nasal Outcome Test (SNOT-22). METHODS: Patients for FESS were preoperatively administered both the ETDQ-7 and the SNOT-22 validated quality of life instruments. Pearson and Spearman correlation coefficients were calculated. Changes in ETDQ-7 were measured at 3 months and differences were compared via paired t test. RESULTS: A total of 82 patients completed the surveys. Thirty-nine (47.6%) patients had ETDQ-7 score ≥14.5, signifying clinically significant ETD symptoms. The mean ETDQ-7 score of the study population was 15.8 ± 8.8, and the mean SNOT-22 score was 37.5 ± 19.7. The Pearson and Spearman correlation coefficients between ETDQ-7 and the total SNOT-22 score were 0.52 (P > .0001) and 0.51 (P < .0001), respectively. There was significant improvement in ETDQ-7 scores postoperatively. CONCLUSION: While the association between ETD and CRS has long been known, this is one of the few prospective patient studies evaluating otologic symptoms in a CRS population. We found that a significant percentage of CRS patients suffer from ETD symptoms based on patient-reported subjective outcome measures. This study demonstrates that otologic symptoms increase with CRS severity and improve after FESS.

Voice-Related Quality of Life in Patients with Chronic Rhinosinusitis.

OBJECTIVE: Chronic rhinosinusitis (CRS) has long been associated with vocal dysfunction. However, studies quantifying the presence of voice dysfunction in CRS patients or the effects of functional endoscopic sinus surgery (FESS) are sparse. The goal of this study was to determine the voice-related quality of life in patients undergoing FESS for CRS using the validated Voice Related Quality of Life Survey (VRQL). We correlated the preoperative VRQL scores to the Sino-Nasal Outcome Test (SNOT-22) scores, and we determined the effect of FESS on postoperative VRQL scores. METHODS: Consecutive patients undergoing FESS were preoperatively administered both the VRQL and the SNOT-22 surveys. Spearman (ρ) and Pearson (r) correlation coefficients were calculated. The VRQL was mailed to patients postoperatively between 3 and 6 months. The paired t-test was used to compare pre- and post-FESS scores. RESULTS: A total of 102 patients were enrolled, and 81 patients completed the two surveys. A total of 51 (62.9%) patients had raw VRQL score ≥ 10, signifying presence of significant vocal symptoms. The mean ± standard deviation (SD) raw VRQL score of the entire study population was 12.4 ± 4.6, and the mean SNOT-22 score was 37.8 ± 19.2. The Spearman correlation coefficient between VRQL and the total SNOT-22 score was 0.34 (P =.002), and the Pearson correlation coefficient was 0.36 (P = .001). Both correlations were similar, demonstrating that increasing severity of CRS symptoms correlates with decreasing voice-related quality of life (QOL). Seventy patients completed the postoperative survey for an 86% retention rate. Thirty-six of these patients had abnormal preoperative VRQL scores, and these patients improved significantly after FESS. The mean preoperative versus postoperative raw scores were 15.2 ± 5.6 versus 12.5 ± 4.1, respectively (P = .003). CONCLUSION: This study demonstrates the increasing presence of vocal complaints with increasing severity of CRS. It also demonstrates that VRQL scores improve after FESS in those patients with preoperative vocal complaints. LEVEL OF EVIDENCE: IV.

Nocturia and associated mortality: observational data from the REDUCE trial.

BACKGROUND: Nocturia (voids arising from sleep) is a ubiquitous phenomenon reflecting many diverse conditions but whether it has significance in its own right remains uncertain. We examined whether nocturia was an independent risk factor for mortality METHODS: These were observational analyses employing primarily North American and European participants and included 7343 men, aged 50-75 years participating in the REDUCE (Reduction by Dutasteride of Prostate Cancer Events) trial. Cox proportional hazards models were used to test the association between baseline nocturia (voiding ≥3 times per night) and all-cause mortality. Potential confounding variables included: age; race; region of origin; treatment group; self-reported coronary artery disease, diabetes mellitus, hypertension, and peripheral vascular disease; smoking; alcohol use; prostate volume; and diuretics. Self-reported sleep quality, as measured with the Medical Outcomes Study sleep scale, was entered as a final step in the model. RESULTS: Nocturia was associated with increased mortality risk (hazard ratio [HR] = 1.72; 95% CI 1.15-2.55) independent from demographics and medical comorbidities. Inclusion of disturbed sleep in the model reduced the magnitude of the association (HR = 1.43; 95% CI 0.93-2.19). CONCLUSIONS: Although the findings are limited to men, half of whom ingested dutasteride, the interruption of sleep by nocturia may have long-term impact on health and may warrant targeted intervention.

Association of Continuous Positive Airway Pressure Treatment With Sexual Quality of Life in Patients With Sleep Apnea: Follow-up Study of a Randomized Clinical Trial.

Importance: Obstructive sleep apnea reduces sexual quality of life (QOL) as a result of reduced libido and intimacy, erectile dysfunction, and several other mechanisms. Treatment for obstructive sleep apnea may improve sexual QOL. Objective: To test the association of long-term continuous positive airway pressure (CPAP) treatment with sexual QOL for patients with obstructive sleep apnea. Design, Setting, and Participants: Prospective cohort study at a single, tertiary medical center of patients with newly diagnosed obstructive sleep apnea who were prescribed CPAP treatment from September 1, 2007, through June 30, 2010 (follow-up completed June 30, 2011). The statistical analysis was performed from February 1 through December 31, 2017. Exposures: Use of CPAP treatment objectively measured by the number of hours per night. Users of CPAP were defined as patients who used CPAP treatment for more than 4 hours per night, and nonusers were defined as patients who used CPAP treatment for fewer than 0.5 hours per night. Main Outcomes and Measures: Data were collected from eligible patients before CPAP treatment was prescribed and 12 months later by using the validated Symptoms of Nocturnal Obstruction and Related Events-25 (SNORE-25) QOL instrument. The 2 sex-specific items used to create the sexual QOL domain were taken from the SNORE-25. The sexual QOL domain was scored in a range from 0 to 5 (higher score is worse). The difference in sexual QOL between CPAP users and nonusers was analyzed using a paired, 2-tailed t test and multivariable linear regression adjusted for potential confounders. Results: Of the 182 participants in the cohort, 115 (63.2%) were men (mean [SD] age, 47.2 [12.3] years) with severe OSA (mean [SD] apnea-hypopnea index, 32.5 [23.8] events per hour). At the 12-month follow-up, 72 CPAP users (mean [SD] use, 6.4 [1.2] hours per night) had greater improvement than 110 nonusers (0 [0] hours per night) in sexual QOL scores (0.7 [1.2] vs 0.1 [1.1]; difference, 0.54; 95% CI, 0.18-0.90; effect size, 0.47). A moderate treatment association was observed after adjustment for age, sex, race/ethnicity, marital status, income level, educational level, body mass index, apnea-hypopnea index, and the Functional Comorbidity Index (adjusted difference, 0.49; 95% CI, 0.09-0.89; effect size, 0.43). Subgroup analysis revealed a large treatment association for women (adjusted difference, 1.34; 95% CI, 0.50-2.18; effect size, 0.87) but not for men (adjusted difference, 0.16; 95% CI, -0.26 to 0.58; effect size, 0.19). Conclusions and Relevance: Successful CPAP use may be associated with improved sexual QOL. Subgroup analysis revealed a large improvement in women but no improvement in men. Further study is warranted to test other measures of sexual QOL and other treatments. Trial Registration: ClinicalTrials.gov Identifier: NCT00503802.

Extended follow-up of palatal implants for OSA treatment.

OBJECTIVE: Evaluate long-term safety and outcomes of palatal implants for patients with mild to moderate obstructive sleep apnea (OSA). STUDY DESIGN AND SETTING: Continuation of a prospective case series of patients with palatal implants. Polysomnography, daytime sleepiness, and snoring intensity were measured at baseline, 90 days, and extended follow-up. RESULTS: Twenty-two (42%) patients from the previous study were followed for a median of 435.5 days. Thirteen were classified as responders, based on their 90-day evaluation. 76.9% of initial responders maintained improvements in apnea-hypopnea index (AHI), daytime sleepiness, and snoring at extended follow-up. Nine patients were initial nonresponders for AHI and daytime sleepiness and remained unchanged at extended follow-up. However, snoring for these nine patients initially improved, and the improvement continued through extended follow-up. CONCLUSION: Initial response or nonresponse to palatal implants remains stable over an extended period. The generalizability of these results is unknown because of significant loss to follow-up. SIGNIFICANCE: Study results report safety and beneficial long-term outcomes of palatal implants for mild to moderate OSA treatment in selected patients.