Mandibular Advancement vs CPAP for Blood Pressure Reduction in Patients With Obstructive Sleep Apnea.

BACKGROUND: Hypertension guidelines recommend diagnosis and treatment of obstructive sleep apnea (OSA) in patients with hypertension. The mandibular advancement device (MAD) is an oral appliance therapy for patients who decline or cannot tolerate continuous positive airway pressure (CPAP). OBJECTIVES: We compared the relative effectiveness of MAD vs CPAP in reducing 24-hour ambulatory blood pressure (BP). METHODS: In an investigator-initiated, randomized, noninferiority trial (prespecified margin 1.5 mm Hg), 321 participants aged ≥40 years with hypertension and increased cardiovascular risk were recruited at 3 public hospitals for polysomnography. Of these, 220 participants with moderate-to-severe OSA (apnea-hypopnea index ≥15 events per hour) were randomized to either MAD or CPAP (1:1). The primary outcome was the difference between the 24-hour mean arterial BP at baseline and 6 months. RESULTS: Compared with baseline, the 24-hour mean arterial BP decreased by 2.5 mm Hg (P = 0.003) at 6 months in the MAD group, whereas no change was observed in the CPAP group (P = 0.374). The between-group difference was -1.6 mm Hg (95% CI: -3.51 to 0.24, noninferiority P < 0.001). The MAD group demonstrated a larger between-group reduction in all secondary ambulatory BP parameters compared with the CPAP group, with the most pronounced effects observed in the asleep BP parameters. Both the MAD and CPAP improved daytime sleepiness, with the between-group difference similar (P = 0.384). There were no between-group differences in cardiovascular biomarkers. CONCLUSIONS: MAD is noninferior to CPAP for reducing 24-hour mean arterial BP in participants with hypertension and increased cardiovascular risk. (Cardiosleep Research Program on Obstructive Sleep Apnea, Blood Pressure Control and Maladaptive Myocardial Remodeling-Non-inferiority Trial [CRESCENT]; NCT04119999).

Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol.

INTRODUCTION: Although treatment of obstructive sleep apnoea (OSA) using continuous positive airway pressure (CPAP) reduces blood pressure (BP), adherence to CPAP is often suboptimal. A mandibular advancement device (MAD) is a guideline-endorsed alternative therapy for OSA. Still, there is limited evidence on the relative efficacy between MAD and CPAP on BP reduction. We evaluate whether treatment of moderate-to-severe OSA using MAD can improve BP and other health-related outcomes compared with CPAP. METHODS AND ANALYSIS: This is a randomised, controlled, non-inferiority trial conducted. We will recruit 220 Asians with a history of hypertension and high cardiovascular risk for an overnight polysomnography screening. Those with moderate-to-severe OSA (apnoea-hypopnoea index ≥15 events/hour) will be randomised to treatment with either MAD or CPAP in a 1:1 ratio. Stratified by age (60 vs <60 years old), body mass index (25 vs <25 kg/m2) and apnoea-hypopnoea index (30 vs <30 events/hour), an adaptive randomisation scheme with permuted blocks constructed in real-time is implemented to restrict imbalance. The overall study duration is 12 months. The primary endpoint is the 24-hour mean arterial BP difference between baseline and 6-month follow-up. The secondary endpoints include other measures of ambulatory BP monitoring, arrhythmia based on a 4-day electrocardiographic monitoring, biomarker and proteomic analysis, cardiovascular magnetic resonance-derived myocardial fibrosis and remodelling and quality-of-life questionnaires. Recruitment began in October 2019 and ended in December 2022. Comparison between MAD and CPAP will be performed using covariance (ANCOVA) analysis of the changes in 24-hour mean arterial BP while adjusting for the baseline 24-hour mean arterial BP. We will compare the 95% CIs around the treatment difference point estimate with the prespecified non-inferiority margin (1.5 mm Hg). If the upper limit of the 95% CI is <1.5 mm Hg and crosses 0, non-inferiority of the MAD relative to CPAP will be established. ETHICS AND DISSEMINATION: The Domain Specific Review Board-C, National Healthcare Group under approved the study protocol (NHG DSRB Ref: 2019/00359, approved on 28 August 2019). Study findings will be disseminated to various local, national, and international audiences through abstract presentations and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04119999.

Obstructive sleep apnea therapy for cardiovascular risk reduction-Time for a rethink?

Obstructive sleep apnea (OSA) is a highly prevalent and underdiagnosed medical condition, which is associated with various cardiovascular and metabolic diseases. The current mainstay of therapy is continuous positive airway pressure (CPAP); however, CPAP is known to be poorly accepted and tolerated by patients. In randomized controlled trials evaluating CPAP in cardiovascular outcomes, the average usage was less than 3.5 hours, which is below the 4 hours per night recommended to achieve a clinical benefit. This low adherence may have resulted in poor effectiveness and failure to show cardiovascular risk reduction. The mandibular advancement device (MAD) is an intraoral device designed to advance the mandible during sleep. It functions primarily through alteration of the jaw and/or tongue position, which results in improved upper airway patency and reduced upper airway collapsibility. The MAD is an approved alternative therapy that has been consistently shown to be the preferred option by patients who are affected by OSA. Although the MAD is less efficacious than CPAP in abolishing apnea and hypopnea events in some patients, its greater usage results in comparable improvements in quality-of-life and cardiovascular measures, including blood pressure reduction. This review summarizes the impact of OSA on cardiovascular health, the limitations of CPAP, and the potential of OSA treatment using MADs in cardiovascular risk reduction.

A wireless and battery-free wound infection sensor based on DNA hydrogel.

The confluence of wireless technology and biosensors offers the possibility to detect and manage medical conditions outside of clinical settings. Wound infections represent a major clinical challenge in which timely detection is critical for effective interventions, but this is currently hindered by the lack of a monitoring technology that can interface with wounds, detect pathogenic bacteria, and wirelessly transmit data. Here, we report a flexible, wireless, and battery-free sensor that provides smartphone-based detection of wound infection using a bacteria-responsive DNA hydrogel. The engineered DNA hydrogels respond selectively to deoxyribonucleases associated with pathogenic bacteria through tunable dielectric changes, which can be wirelessly detected using near-field communication. In a mouse acute wound model, we demonstrate that the wireless sensor can detect physiologically relevant amounts of Staphylococcus aureus even before visible manifestation of infection. These results demonstrate strategies for continuous infection monitoring, which may facilitate improved management of surgical or chronic wounds.

Wirelessly operated bioelectronic sutures for the monitoring of deep surgical wounds.

Monitoring surgical wounds post-operatively is necessary to prevent infection, dehiscence and other complications. However, the monitoring of deep surgical sites is typically limited to indirect observations or to costly radiological investigations that often fail to detect complications before they become severe. Bioelectronic sensors could provide accurate and continuous monitoring from within the body, but the form factors of existing devices are not amenable to integration with sensitive wound tissues and to wireless data transmission. Here we show that multifilament surgical sutures functionalized with a conductive polymer and incorporating pledgets with capacitive sensors operated via radiofrequency identification can be used to monitor physicochemical states of deep surgical sites. We show in live pigs that the sutures can monitor wound integrity, gastric leakage and tissue micromotions, and in rodents that the healing outcomes are equivalent to those of medical-grade sutures. Battery-free wirelessly operated bioelectronic sutures may facilitate post-surgical monitoring in a wide range of interventions.

The Emerging Role of Drug-Induced Sleep Endoscopy in the Management of Obstructive Sleep Apnea.

Obstructive sleep apnea is a prevalent sleep disorder characterized by partial or complete obstruction of the upper airway. Continuous positive airway pressure is the first-line therapy for most patients, but adherence is often poor. Alternative treatment options such as mandibular advancement devices, positional therapy, and surgical interventions including upper airway stimulation target different levels and patterns of obstruction with varying degrees of success. Drug-induced sleep endoscopy enables the visualization of upper airway obstruction under conditions mimicking sleep. In the era of precision medicine, this additional information may facilitate better decision-making when prescribing alternative treatment modalities, with the hope of achieving better adherence and/or success rates. This review discusses the current knowledge and evidence on the role of drug-induced sleep endoscopy in the non-positive airway pressure management of obstructive sleep apnea.

Influence of short-term side effects on oral sleep appliance compliance among CPAP-intolerant patients: An objective monitoring of compliance.

OBJECTIVES: To investigate the predictive value of side effects on usage times during the initial titration phase of oral appliance therapy for sleep apnoea. The secondary objective was to assess the correlation between subjective and objective usage times. METHODS: A total of 21 subjects diagnosed with sleep apnoea and a history of non-compliance with CPAP therapy were enrolled in the 4-week clinical study. Objective compliance was assessed through an intra-oral compliance monitor embedded in a Thornton Adjustable Positioner. Subjective compliance was evaluated through self-reporting and questionnaire for side effects. RESULTS: Excess salivation, xerostomia and tooth discomfort were the most common side effects (61%-67%). Noises (OR = 10, 95% CI = 0.85-117.02, P = 0.067), jaw discomfort (OR = 15, 95% CI = 1.21-185.20, P = 0.035) and gum discomfort (OR = 8.86, 95% CI = 1.0-∞, P = 0.038) were highly predictive of non-compliance. Subjects with either "none" or "mild" side effects recorded a mean oral appliance usage time ≥5.5 hours/night, while subjects reporting "severe" side effects recorded a mean usage time ≤4 hours/night. The mean usage time was 5.49 hours/night, with nightly compliance (defined as >4 hours per night for 70% the nights per week) at 33%. Nonetheless, compliance increased from 26%-50% from week 1 to week 4. The subjective and objective usage times were highly correlated (r = 0.81). CONCLUSIONS: There was a high correlation between subjective and objective compliance reporting data. Moderate/severe side effects had the greatest effect on compliance.

Investigating the association between obstructive sleep apnea and periodontitis.

BACKGROUND: Obstructive sleep apnea (OSA) is a sleep disorder characterized by disruptions of normal sleep architecture. Chronic periodontitis is a chronic disease of the periodontium that elicits a general inflammatory response to local dental plaque. It has been suggested that periodontal disease may increase in severity with increasingly severe OSA because both disease entities share common inflammatory pathways, acting synergistically to alter the host response. The aim of this study is to analyze the association between severity of OSA and the prevalence/severity of periodontitis. METHODS: One hundred patients from a large veterans administration sleep study center (n = 26 normal, n = 21 mild, n = 19 moderate, n = 34 severe) diagnosed with an overnight polysomnogram underwent a comprehensive periodontal examination. Periodontal parameters measured included the following: 1) mean periodontal probing depth (PD); 2) clinical attachment level (CAL); 3) gingival recession; and 4) percentage of sites with bleeding on probing, plaque, PD ≥5 mm, and CAL ≥3 mm. RESULTS: Seventy-three percent of the sampled population had moderate/severe periodontal disease. χ(2) analyses revealed no significant differences in the prevalence of periodontal disease between the apnea-hypopnea index (AHI) groups, with a negligible Spearman correlation coefficient of 0.246 between AHI severity and periodontal disease severity categories. Analysis of covariance indicated a significant association between AHI severity categories and percentage of sites with plaque, after adjusting for age. Multivariable logistic regression analysis predicting moderate/severe periodontitis with AHI score, age, and smoking status indicated a significant association with age (P = 0.028) but no significant association with the other two predictors. CONCLUSION: OSA was not significantly associated with the prevalence of moderate/severe periodontitis and the periodontal parameters examined, except percentage plaque.

Formulating a global prognosis and treatment plan for the periodontally compromised patient: a reconstructive vs. an adaptive approach.

The clinician faces treatment planning challenges when patients present with generalized severe chronic periodontitis that may result in tooth loss. This article provides a treatment planning discussion along with approaches for treating such patients. It presents the clinical question: What is the best means for approaching treatment planning in a patient with severe periodontitis requiring extraction and replacement of some teeth? Two treatment approaches are discussed­a reconstructive approach versus an adaptive one­both of which have an end goal of achieving periodontal health and occlusal stability, and each has its own advantages and disadvantages. In conclusion, utilizing a global prognostic approach will assist clinicians anticipate the eventual restorative needs of patients and prescribe customized periodontal and restorative therapies that best address those needs.