Martin L. Hopp

Palatal implants: A new approach for the treatment of obstructive sleep apnea

OBJECTIVE: To evaluate the short-term safety and efficacy of palatal implants in patients with mild and moderate obstructive sleep apnea (OSA). STUDY DESIGN AND SETTING: A prospective, non-randomized study conducted at 5 clinical sites. Three polyester implants were placed in the soft palate under local anesthesia during a single-stage office procedure. Polysomnography was conducted at baseline and 90 days post-procedure. Subjective quality of life data were collected. RESULTS: Fifty-three patients were evaluated; the apnea hypopnea index (AHI) decreased from 25.0 ± 13.9 to 22.0 ± 14.8 events/hour (P = 0.05). The Epworth Sleepiness Scale (ESS) decreased from 11.0 ± 5.1 to 6.9 ± 4.5 (P < 0.001), and the snore score decreased from 7.9 ± 2.1 to 4.0 ± 3.0 (P < 0.001). No serious complications occurred during the study. CONCLUSION: Palatal implants can be an effective initial low morbidity treatment option for patients diagnosed with mild to moderate OSA.

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.

Soft Palate Implants: A New Treatment for Obstructive Sleep Apnea?

Abstract Problem: Pillar soft palate implants are a new treatment for snoring. However, the effects of the implants in the treatment of obstructive sleep apnea (OSA) have not been studied. In this pilot study, we examined the safety and efficacy of the placement of implants in the soft palate of patients diagnosed with OSA. Methods: Adult patients with a diagnosis of mild to moderate obstructive sleep apnea were chosen to participate in this multi-center, nonrandomized, prospective, clinical study. Patients with other mitigating procedures or previous surgical treatments of the soft palate or upper airway and significant nasal and/or tongue obstruction were excluded. All patients will have an attended, in-laboratory polysomnogram prior to and 6 months following the implant procedure. Results: At this time, a total of 4 patients have been enrolled in this study. To date, there have been no adverse events. Our preliminary results demonstrate a clinical improvement in symptoms associated with OSA. Polysomnographic data are forthcoming. Conclusion: Our initial impression is that palatal implants can be safely placed in patients with mild to moderate obstructive sleep apnea. Also, a clinical improvement has been noted in the symptoms associated with OSA. Significance: Palatal implants may be a new treatment for the treatment of obstructive sleep apnea. Support: None reported.

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 &agr;‐blockers or 5&agr;‐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.

Nocturia and associated mortality: observational data from the REDUCE trial

BackgroundNocturia (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 mortalityMethodsThese 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.ResultsNocturia 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).ConclusionsAlthough 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

MP13-13 DOES TREATING NOCTURIA LEAD TO BETTER SLEEP? RESULTS FROM REDUCE

an increased risk of lower urinary tract symptoms (LUTS) relative to daytime workers, and are also at increased risk for shift work sleep disorder (SWSD), a primary circadian rhythm disorder indicated by excessive daytime sleepiness associated with shiftwork. Here we examine the association between SWSD and LUTS in shift workers. METHODS: Men presenting to a single andrology clinic between July 2014 and September 2016 completed questionnaires that assessed work schedule, SWSD risk, and LUTS (International Prostate Symptom Score (IPSS)). The impact of non-standard shift work and SWSD on IPSS score was assessed using ANOVA and linear regression. RESULTS: Of the 2,487 men who completed the questionnaires, 766 (30.8%) reported working non-standard shifts in the past month. Of these, 282 (36.8%) were diagnosed with SWSD. Cohort characteristics are described in Table 1. When controlling for age, comorbidities (via the Charlson Comorbidity Index), and testosterone (T) levels, non-standard shift work was not associated with worse LUTS (P1⁄40.99). However, non-standard shift workers diagnosed with SWSD had IPSS scores 3.1 points higher than non-standard shift workers without SWSD (P<0.0001). CONCLUSIONS: Non-standard shift workers diagnosed with SWSD have worse LUTS than those without SWSD, suggesting that poor sleep habits, rather than shift work itself, contribute to worse LUTS. Modification of work and sleep schedules may reduce the risk for SWSD and subsequent LUTS.

Sleep disorders committee: Thinking about opening your own sleep lab?

Abstract Otolaryngologists are increasingly involved in the diagnosis and treatment of snoring and sleep apnea. Sleep studies are an essential part of treating this substantial population of patients. Sleep studies can be performed at home, in a hospital, or in a freestanding sleep laboratory. Most of these laboratories are owned or managed by neurologists or pulmonologists who specialize in sleep medicine. Otolaryngologists are currently dependent on these labs and their interpreting physicians to obtain the data necessary to advise and treat their patients. Are otolaryngologists sleeping on the job? Should we open our own sleep laboratories or perform home studies? Performing sleep studies and dispensing CPAP devices is comparable to ordering an audiogram and dispensing hearing aids. Otolaryngologists own the equipment needed to perform an audiogram, hire audiologists to work in their office, interpret the audiogram, and then recommend and provide surgical and/or medical treatment. Can and should we do the same for sleep patients? The purpose of this seminar is to explore the pros and cons of opening your own sleep lab. The debate over home sleep studies versus in laboratory attended studies will be discussed. The practical experience of one of our colleagues on how to go from the idea to the reality of owning and running a sleep lab will be presented. Performing CPAP titration studies and dispensing CPAP will be addressed. Business and legal issues will be reviewed as well.