Study objectives:The Onera Sleep Test System (STS), the first wireless, patch-based, type II polysomnography (PSG) device designed to enable unattended sleep studies at the patient's home, has been introduced. This multicentre study validated data collected from the patch-based PSG against traditional PSG for the classification of sleep-related respiratory events. Materials and methods:Seven clinical sites recruited 206 participants to complete a simultaneous sleep study in the sleep laboratory with a traditional PSG and a patch-based PSG system. Three independent scorers, blinded to patient and device type, evaluated the traditional PSG and patch-based PSG recordings in accordance with American Academy of Sleep Medicine (AASM) 2020 (Version 2.6) guidelines. Results:The subjects were middle aged and mildly obese (50.9±12.3 years of age, body mass index 30.2±6.2). There was strong positive correlation between the apnoea-hypopnoea index ((AHI) using 3% desaturation or arousal rule) (0.90), apnoea index (0.89), central apnoea index (0.78), obstructive apnoea index (0.86), hypopnoea index (0.68) and arousal index (0.72) measured by the two devices. Differences in oxygen saturation (S pO2 ) measurement were seen as a function of measurement site with the forehead measurements showing higher S pO2 values. The patch-based device showed diagnostic utility (AUC ≥0.8) for AHI severity thresholds at 5, 15 and 30. Conclusions:The Onera STS patch-based PSG system demonstrated reasonably good agreement with traditional PSG systems in detecting sleep-disordered breathing events and in diagnosing obstructive sleep apnoea by the AHI.
RATIONALE:Obstructive sleep apnea (OSA) is characterized by recurrent upper airway (UA) collapse during sleep. Continuous positive airway pressure (CPAP) is an effective but often poorly tolerated treatment. Neurostimulation targeting UA dilators has emerged as an alternative therapy, though coordinating stimulation of multiple effector muscles may be challenging. Phrenic nerve stimulation (PNS) offers a potential alternative that may engage both efferent and afferent respiratory mechanisms to enhance airway patency. OBJECTIVE:To examine how PNS timing affects UA patency in OSA patients undergoing drug-induced sleep endoscopy. METHODS:Obstructive sleep apnea patients underwent drug-induced sleep endoscopy. Subtherapeutic CPAP was applied to maintain stable flow-limited breathing for PNS experiments. Transcutaneous PNS was delivered via a cervical electrode at different phases of respiration: end-expiration to inspiration (E→I), inspiration only (I→I), and mid-inspiration to expiration (I→E). Sequential stimulations were also performed at E→I to observe sustained effects. Effect of stimulation on inspiratory flow (VI), tidal volume (TV), and minute ventilation (MV) were quantified using mixed-effects models. MEASUREMENTS AND MAIN RESULTS:A total of 19 patients participated: 13 completed both isolated and sequential protocols, and 6 completed only the sequential protocol. Isolated PNS timed to E→I increased VI (64%) and TV (71%) compared with baseline. Sequential PNS at E→I produced sustained improvements with further increases in VI (171%), TV (173%), and MV (169%). CONCLUSIONS:Phrenic nerve stimulation delivered at end-expiration significantly improved UA patency and ventilation, with sequential stimulation further potentiating these effects. Phase-locked PNS responses implicate underlying neural afferent mechanisms and suggest novel PNS strategies for treating OSA.
The demand for in-laboratory polysomnography (PSG) is expected to outgrow the amount of dedicated beds, PSG equipment and trained personnel over the next 10 years. The Onera Sleep Test System (STS) is a patient applied, patch-based, type II PSG system, which enables PSG studies to be performed unattended at the patient’s home. We report patient perception of the patch-based system and confidence in using it to perform an unsupervised home study. 356 patients (age: 50.6 ± 12.7, male/female: 66.7%/ 33.3%, BMI: 30.2 ± 7.9) were recruited for a multicentre trial in Germany validating the Onera STS patch-based PSG system against traditional PSG in the sleep laboratory. 333 patients completed a first impressions questionnaire in full, and 328 completed a user perception questionnaire in full. 204 patients completed the second phase of the study where they used the patch-based system unsupervised at home, from which 172 patients completed the At-Home questionnaire in full. Demographics for each subset of participants were similar to the original cohort. Upon first impression, 84.1% of patients liked the size of the patch-based PSG system, 93.7% had no concerns about wearing it and 82.6% were confident that they could fit the device at home, unsupervised. Following at-home use, 77.3% reported no difficulties in applying the system, 90.7% were confident that they had placed the sensors correctly and 90.7% were satisfied with the system in general. Comfort with the patch-based system was high with the majority of patients agreeing that the leg (90.1%), flow (90.7%), chest (89.4%) and head sensor (80.1%) were comfortable. Upon first impression, the majority of patients were not intimidated by the patch-based PSG and were confident that they could fit it unsupervised at home. The level of issues experienced during unsupervised home use was low and most patients were satisfied with their experience. The majority of patients rated the patch-based PSG as comfortable following overnight use. Onera Health
Onera Health has developed the first wireless, patch-based, type-II polysomnography (PSG) system, the Onera Sleep Test System, to allow studies to be performed unattended at the patient’s home or in any bed at a medical facility. The goal of this multicenter study was to validate data collected from the patch-based PSG to a traditional PSG for sleep staging and apnea-hypopnea index. Simultaneous traditional PSG and patch-based PSG study data were obtained in a sleep laboratory from 206 participants with a suspected sleep disorder recruited from 7 clinical sites. Blinded, randomized scoring of the traditional PSG and patch-based PSG recordings was completed according to The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications (Version 2.6) criteria by 3 independent scorers. Concordance correlation coefficients were high between the patch-based device and traditional PSG across essential sleep and respiratory variables—total sleep time (.87); wake (.84); non-rapid eye movement (REM) (.80); non-REM sleep stage 1 (N1) (.72); non-REM sleep stage 2 (N2) (.71); non-REM sleep stage 3 (N3) (.64); REM (.80); and apnea-hypopnea index (AHI) (.94). There was substantial agreement between epoch sleep staging scored on the patch-based device and traditional PSG (average Cohen’s kappa of 0.62 ± 0.13 across all scorers). The patch-based type-II PSG had a similar performance on sleep staging and respiratory variables when compared to traditional PSG, thus making it possible to use the patch-based PSG for a routine PSG study. These results open the possibility of performing unattended PSG studies efficiently and accurately outside the sleep laboratory improving access to high quality sleep assessments for patients with sleep disorders. Registry: ClinicalTrials.gov; Name: Validation Study of a Patch-based PSG System; URL: https://clinicaltrials.gov/study/NCT05310708 ; Identifier: NCT05310708. Viniol C, Galetke W, Woehrle H, et al. Clinical validation of a wireless patch-based polysomnography system. J Clin Sleep Med. 2025;21(5):813–823.
Background: Inhaled medications are commonly used as therapy for obstructive lung disease (OLD); however, poor technique from pressurized metered dose inhalers (pMDIs) can severely limit drug delivery and therapeutic efficacy. A novel flow sensor has been developed to characterize inhalation flow profiles from pMDIs. Research Question: Among patients with OLD, does recording flow profiles during pMDI inhalation maneuvers expose poor patterns of pMDI use, which can be used to remediate pMDI technique? Study Design and Methods: A novel flow sensor was coupled with a placebo pMDI to characterize inhalation technique in 70 participants with OLD from a pulmonary clinic. pMDI inhalation flow profiles generated actuation timing, mean inspiratory airflow, and inspired volume before and after visualizing these features. McNemar test was used to characterize the impact of training on pMDI inhalation metrics. The postactuation inspired volume was normalized to inspiratory capacity. Results: Among participants with a mean ± SD of 17.4 ± 17.9 years of pMDI use, flow profiles uncovered mistimed actuations in 47.1% and poor inspiratory flow rates in 30.0% of patients. After visualizing flow profiles, participants improved actuation timing (χ2 =12.042; P < .001), mean inhaled volume (87.9% to 105.6% of inspiratory capacity; P < .001), and the combined inhalation metrics (χ2 =8.45; P = .003). Interpretation: Flow profiles helped uncover and remediate specific defects in pMDI technique in most chronic users with OLD. Flow profiles from inhaled medications can be used to enhance drug delivery to the lung. Clinical Trial Registration: ClinicalTrials.gov; No.: NCT05495256; URL: www.clinicaltrials.gov
Rationale: The gold standard for sleep diagnostics is in-laboratory (in-lab) polysomnography, which is time consuming, costly and requires attendance and analysis by a trained sleep technician which are in short supply. The Onera Sleep Test System (STS) is a patient applied patch-based system, which enables a PSG to be performed unattended at the patient's home. Method: 206 subjects (age 50.9±2.3, male 66%, BMI 30.2±6.2) with suspected sleep disorders were recruited from 7 clinical sites and underwent a single night, simultaneous, in-lab PSG and Onera patch-based PSG recording. Blind scoring was completed according to the AASM criteria by 3 independent scorers. Results: The average application time of the in-lab PSG was 19.5±6.8 minutes and the patch-based PSG was 5.8±1.8 minutes. Concordance Correlation Coefficients between in-lab PSG and patch-based PSG were 0.87 TST, 0.80 NREM, 0.80 REM, 0.90 AHI 3% rule, and ODI 0.80. Precision sensitivity and specificity at an AHI≥5 were 0.86, 0.85 and 0.75, AHI≥15 were 0.83, 0.78 and 0.92, AHI≥30 were 0.84, 0.82 and 0.97 respectively. There were no serious adverse events reported. Conclusion: Application of the patch-based PSG could be done in a third of the time compared to in-lab PSG. The scored data from the patch-based PSG showed strong concordance with that from the in-lab PSG. The patch-based PSG showed good accuracy, sensitivity, and specificity at each of the AHI thresholds. The patch-based PSG can be used to accurately measure sleep in the patient's home environment.
Background: Intraoral devices, with or without negative oral pressure, can stabilize the oropharynx and reduce obstructive sleep apneas. We tested the hypothesis that treatment with the iNAP (R) Sleep Therapy System, which applies negative oral pressure through an intra-oral appliance, would reduce the severity of obstructive sleep apnea in a multi -center, prospective, first -night -randomized -order cross -over study. Methods/patients: 130 patients fulfilled the entry criteria (age <75, AHI 15 -55, BMI <33), and 63 entered the primary endpoint cohort (Total Sleep Time >= 4 h/night on the baseline polysomnogram and an oral negative vacuum time maintained by iNAP (R) >= 4 h/night and total sleep time >= 4 h/night during the first treatment study). 54 patients completed a second treatment sleep study at least 28 days after the first sleep study. Results: Among the primary endpoint cohort (n = 63, age = 53.2 +/- 11.3, BMI = 27.1 +/- 2.8), 33 patients (52 %; 95 % confidence interval = 40% -64 %, p < 0.001) responded to iNAP treatment according to the Sher criteria ( >50 % reduction in AHI and an AHI <= 20 events/hr). The average oxy-hemoglobin saturation increased by 1 -2%, and the average percent oxygen desaturation decreased (was less severe) by 1 % while using the iNAP device. The incidence of adverse events, all self -limited, was low. The reduction in the apnea-hypopnea index was durable over the 28 -day study. Patients used iNAP on average 5.6 h per night during the study period. Conclusion: The iNAP (R) Sleep Therapy System achieved a durable benefit in more than half the patients with moderate to severe obstructive sleep apnea and may be considered in patients who object to or failed continuous positive airway pressure. Clinical trial registration: ClinicalTrials.gov Identifier: NCT02698059.
Background Inhaled medications are commonly used as therapy for obstructive lung disease (OLD) yet poor technique from pressurized metered dose inhalers (pMDI) can severely limit drug delivery and therapeutic efficacy. A novel flow sensor has been developed to characterize inhalation flow profiles from pMDIs. Research Question Among OLD subjects, flow profiles during pMDI inhalation maneuvers would expose poor patterns of pMDI use, which can be used to remediate pMDI technique. Study Design and Methods A novel flow sensor was coupled to a placebo pMDI inhaler to characterize inhalation technique in 70 OLD participants from a pulmonary clinic. pMDI inhalation flow profiles generated actuation timing, mean inspiratory airflow (MIF) and inspired volume before and after visualizing these features. McNemar’s was used to characterize the impact of training on pMDI inhalation metrics. The post-actuation inspired volume was normalized to inspiratory capacity (IC). Results Among participants with 17.4 (SD = 17.9) years of pMDI use, flow profiles uncovered mistimed actuations in 47.1% and poor inspiratory flow rates in 30.0% of subjects. After visualizing flow profiles, participants improved actuation timing (c2(1) =12.042, p < .001), mean inhaled volume (87.9 to 105.6% of IC, p<0.001) and the combined inhalation metrics (c2(1) =8.45, p = 0.003). Interpretation Flow profiles helped uncover and remediate specific defects in pMDI technique in the majority of chronic OLD users. Flow profiles from inhaled medications can be used to enhance drug delivery to the lung.
Abstract Introduction Evidence underlines the association between disordered sleep and adverse health outcomes such as, hypertension, cardiovascular and cerebrovascular disease, and metabolic disorders. A variety of sleep test modalities are available, ranging from ambulatory single-channel sleep tests to in-lab technician-supervised polysomnography (PSG). These tests are selected by the clinician based on the patients overall health profile, which sleep disorders are being investigated, and which tests are covered by insurance providers. The aim of this research was to evaluate trends in utilization of different sleep diagnostic tests among Medicare beneficiaries. Methods A retrospective analysis of sleep test utilization was conducted using a public data set curated by the Center of Medicare and Medicaid Services. Available data included information on services, categorized by HCPCS or CPT code, submitted and paid charges, beneficiary demographics and health characteristics for the years 2011 to 2021. Results From 2011 to 2021, sleep service utilization among Medicare beneficiaries decreased from 803,280 to 694,375 with a peak of 963,780 procedures in 2018 (-13.6%; Compound Annual Growth Rate (CAGR) = -1.4%). Despite a slight decline in overall sleep studies, unattended type 3 studies / Home Sleep Apnea Tests (HSAT) grew by 632.6% (CAGR = 22.0%), and replaced attended sleep studies as the main diagnostic test for sleep disorders. Attended sleep studies and split-night study utilization almost halved over the period analyzed (-44.9% and -45.6%, CAGR = -5.8% and -5.9%), while the share of unattended studies / HSAT grew from 4.7% in 2011 to 34.5% in 2021. When excluding the pandemic years 2020 and 2021, overall sleep study utilization grew by 18.0%. This development was entirely driven by increased use of unattended type 3 studies / HSAT (+616.5%; CAGR 25.2%), while attended sleep studies and split-night studies decreased by -15.5 and -7.3% respectively (CAGR -2.4% and -1.7%). Conclusion Utilization of sleep diagnostic tests among Medicare beneficiaries underwent significant changes since 2011, with a large shift occurring from in-lab sleep studies to simpler unattended at-home tests. While attended sleep studies, such as in-lab PSG, split-night titrations and vigilance tests were already declining before the pandemic, this event accelerated the transition towards at-home diagnostic testing. Support (if any)
Abstract Introduction Sleep is critical for health and wellbeing. Left untreated, sleep disorders negatively impact daily functioning and quality of life. The gold-standard for sleep monitoring and diagnosis is in-lab polysomnography (PSG). Though PSG provides a comprehensive overview of sleep, it is uncomfortable due to the amount of sensors, which prohibit movement and disturb sleep. A wireless patch-based PSG system, the Onera Sleep Test System (STS), consisting of four body-worn sensors, was recently introduced to overcome these limitations. The objective of this study is to evaluate patient-reported experience when using the Onera STS. Methods Forty-two patients were enrolled in Germany as part of an ongoing validation study. Participants were asked to fill in two questionnaires. The first, administed before the Onera STS sleep study, asked open-ended questions on their first impression of the device. The second, administered after the Onera STS sleep study, focused on the ease of use of the device and comfort of wearing it during the night using a 5-point Likert scale. Results Thirty-six patients completed the first questionnaire (85%) and 39 (93%) the second. First impression of the Onera STS was positive by 86% of patients. The size of the sensors was described as acceptable by 72%. Participants stated that the device looked more comfortable than in-lab PSG and they expected improved sleep quality and a more accurate diagnosis. After completing the PSG with the Onera STS system, 69% found wearing the four sensors comfortable, and no participant expressed strong discomfort during the sleep study. The Forehead sensor was considered the most comfortable (based on 77% stating strongly agree or agree), followed by the Abdomen sensor (74%), the Leg sensor (72%), and the Chest sensor (69%). Most participants (72%) expressed confidence in their ability to fit the sensors by themselves at home. Only one participant preferred to be supported by a technician for the application of the system. Conclusion The first impression of the Onera STS device were positive, and participants found it comfortable during sleep. The majority considered the application simple enough for unsupervised self-application, which can allow patients to undergo a PSG in the comfort of their own home. Support (if any)
Abstract Introduction Current attended in-lab polysomnographic sleep studies are time-consuming and costly, primarily due to the time required to “hook-up” a patient to multiple electrodes and sensors and meet the quality assurance and safety requirements of an in-lab study. We developed a wireless PSG system (Onera STS - Onera Health, NL) consisting of four disposable patches and reusable pods to record full polysomnography that may reduce hook-up time while preserving standards of an attended polysomnography in the lab. Methods We used the Onera STS system for monitoring EEG, EOG, EMG, forehead reflectance SaO2, ECG, bioimpedance derived respiratory airflow and effort, airflow via nasal cannula, snoring sounds, body position, actigraphy, and leg movements, and accessory online monitoring of finger SaO2, ECG, nasal cannula airflow and video via RemLogic 4.0 or REM logic MPR system for Q/A and safety monitoring. Seventeen subjects (8 male, 9 female, age 18-to-75 yrs, BMI 29.9±6.0 kg/m2) were monitored for the evaluation of sleep apnea. We measured hook-up times and observed oxygen saturation and cardiac rhythm throughout the night. Results Mean hook-up time for the Onera STS was 5:22±1:17 minutes and for the additional on-line sensors (Finger SaO2, ECG and nasal cannula) was 3:15±1:10 minutes, resulting in an average hook-up time of less than 10 minutes. Onera PSG data revealed a mean oxygen desaturation event rate of >3% (ODI3) of 8.8 (SD 18.6) and a mean fall of oxygen saturation (ΔSaO2/event) of 4.4 (SD 1.2). The accessory online SaO2, ECG and video monitoring showed that no subjects demonstrated sustained nocturnal hypoxia, severe cardiac arrhythmia or parasomnia events that would have required interventions. Conclusion The Onera STS system substantially lowers the burden to conduct attended polysomnographic sleep studies. In combination with standard monitoring of SaO2, ECG and video, it meets the safety requirements for attended sleep studies while reducing the overall operational and capital equipment costs. The ease of application together with the reduced hook-up time makes it now possible to implement polysomnographic sleep studies in the hospital setting, particularly in addition to conventional bedside monitoring units such as ICU-, step-down unit- or hospital beds. Support (if any)
The effectiveness of a universal adhesive applied in three application modes for the preparation of Class V composite restorations was evaluated both clinically and by quantitative marginal analysis (QMA) over 36 months. In 50 patients, three (n = 21) or four (n = 29) non-carious cervical lesions (NCCL) were restored with Venus® Diamond Flow (Kulzer GmbH, Hanau, Germany). The adhesive iBond® Universal (iBU, Kulzer, Germany) was used in self-etch (SE), etch-and-rinse (ER), or selective-enamel-etch mode (SEE). The etch-and-rinse adhesive OptiBondTM FL served as a control (OFL, Kerr GmbH, Herzogenrath, Germany). The restorations were clinically assessed (FDI criteria) at 14 days (BL), 6, 12, 24, and 36 months. Additionally, QMA was conducted on all restorations of 11 randomly selected patients. FDI criteria and marginal gap and perfect margin were compared between and within groups and recalls using McNemar, Wilcoxon, or Mann–Whitney U-tests (α = 0.05). Starting with 12 months, cumulative failure rates were lower in iBU-SE (0.0%, p = 0.016) and iBU-ER groups (2.1%, p = 0.07) compared to OFL (16.7%). At two years, iBU-SEE also showed fewer failures (0.0% SEE vs. 34.6% OFL, p = 0.016), as did iBU-SE compared to iBU-ER after 36 months (2.2 and 19.6%, p = 0.039). From BL, the iBU-SEE group always had the fewest marginal gaps and the highest percentage of perfect margins. From BL, iBU-SEE (0%, p = 0.008) and iBU-ER (0.2%, p = 0.027) showed significantly fewer marginal gaps compared to OFL (2.5%) and more perfect margins were found with iBU-SEE starting at 6 months (p = 0.054). The SEE and ER modes ensured the most excellent marginal quality, with differences from the control appearing earlier with QMA than clinically. In restoring NCCls, iBU showed superior clinical performance over OFL, especially in modes SE and SEE.
A new anticancer-active platinum(II) compound [Pt(A9pyp)(dmso)(cbdca)], containing the E-1-(9-anthryl)-3-(2-pyridyl)-2-propenone ligand (abbreviated as A9pyp) has been synthesized by the replacement of the anionic chloride ligands in cis-[Pt(A9pyp)(dmso)Cl2] by the dianionic chelating cyclobutanedicarboxylate ligand (abbreviated as cbdca). The in vitro relevance of the leaving group of these new platinum(II) compounds has been investigated. Measurements of the time-dependent intracellular accumulation of both compounds in human ovarian carcinoma cell lines show that the leaving group affects their cellular uptake. In addition, the leaving group also influences DNA platination, and, therefore, has an effect on the biological activity against a pair of human ovarian carcinoma cell lines, i.e. sensitive and resistant to cisplatin.
The standard site for measuring oxygen saturation (SaO2) during sleep is a finger. However, multiple studies show that oxygen measurements on the head (earlobe or forehead) are more sensitive and have greater measurement accuracy, particularly in patients with poor peripheral perfusion such as hypotension and peripheral vasoconstriction, both of which are commonly observed during sleep. Onera has developed and CE marked a patch-based PSG system that uses a forehead reflectance sensor for measuring SaO2. In 17 subjects (9f,8m; BMI 29.9kg/m2 SD 6.0), we performed an Onera PSG study together with a finger SaO2 measurement (Natus MPR with Nonin 8000S). We hypothesized that the forehead sensor would result in a higher mean SaO2 than the finger and also measured SaO2 responses to sleep apnea events such as desaturation event rate of >3% (ODI3) and mean fall of oxygen saturation (ΔSaO2). Overnight mean SaO2 of the forehead sensor was 95.1% (SD 2.4) compared with 94.3% (SD 2.0) of the finger SaO2, p=0.032. ODI3 or ΔSaO2 did not differ between both sensors: ODI3 8.8 (SD 18.6) vs. 10.4 (SD 17.9), p=0.32, mean ΔSaO2 4.4% (SD 1.2) vs. 4.1% (SD 1.4), p=0.4. Two subjects had a 3% and three subjects a 2-3% higher overnight SaO2 at the forehead compared to the finger, while 2 subjects had a lower SaO2 at the forehead (-2.3% and -3%). The mean nocturnal SaO2 at the forehead was higher compared to the finger without affecting SaO2 responses to respiratory events. While the average difference was not clinically significant, approx. 30% had a higher and 10% a lower forehead oxygen saturation. Further studies are required to determine the influence of co-morbid factors on the forehead and finger oxygen mesurements.
Background: Polysomnography (PSG) is the gold standard for diagnosing and monitoring sleep disorders, however, it is time-consuming and costly, as the application of the equipment can only be done by trained sleep technicians and the test must be conducted within a sleep laboratory. Objectives: In this study we assessed the performance of the first wireless patch-based PSG system, the Onera Sleep Test System (STS), which can be applied by the patient and performed outside of the sleep laboratory in settings such as the home. To achieve this, sleep stage and physiological data from the Onera STS were compared to gold standard in-lab PSG. Materials and methods: The recordings were unsupervised to simulate a home-use environment. Epoch-by-epoch agreement was assessed by calculating sensitivity, specificity, accuracy, and Cohens kappa coefficient. Pearsons correlation coefficients were calculated for multiple sleep parameters to measure the level of entire night agreement. Results: Substantial agreement with a Cohens kappa of 0.69 across all sleep stages was determined, which reached 0.81 when Stage N1 was removed from the analysis. A high accuracy, specificity, and sensitivity were found for wake N2, N3 and REM. Although specificity (95.25%) and accuracy (89.62%) were high for N1, sensitivity was low (27.19%). Sleep parameters calculated by sleep stage transitions, apnea hypopnea index and oxygen desaturation index, showed strong correlations. Conclusions: The Onera STS provides comparable clinical information to traditional PSG. Moreover, the application time was reduced by 77% which reduces the overall costs of PSG. These results open the possibility for PSG studies to be performed efficiently outside of the sleep laboratory at a larger scale, thus improving access for patients.
PURPOSETo compare a self-etch and a two-step etch-and-rinse adhesive in terms of internal and marginal composite-tooth bond failure separately on enamel and dentin/cement at 36-48 months after restoration placement using optical coherence tomography (OCT).MATERIALS AND METHODSTwenty-seven patients with two or three class V composite restorations of noncarious cervical lesions 36-48 months after placement were included. The one-step self-etch adhesive Futurabond M ([Voco] group SE, n = 25) and the two-step etch-and-rinse adhesive Solobond M ([Voco] group ER, n = 20) combined with the nanohybrid composite Amaris (Voco) were evaluated. The four-step etch-and-rinse adhesive Syntac classic combined with Tetric EvoCeram (Ivoclar Vivadent) served as the control (n = 18). Spectral-domain OCT (SD-OCT, 1310-nm center wavelength) was applied. Marginal gaps and internal interfacial adhesive defects were quantified in cross-sectional OCT images. Groups were statistically compared using the Friedman/Wilcoxon test (α = 0.05).RESULTSIn enamel, nonsignificantly different percentages of marginal gap formation and internal interfacial adhesive defects were found between the groups (pi ≥ 0.258). In dentin/cement, SE showed significantly less marginal gap formation compared to ER (p < 0.001) and control (p = 0.001), and at the internal dentin-composite interface less adhesive defects were found compared to ER (p < 0.001) and control (p = 0.003).CONCLUSIONThe self-etch adhesive used in the current study appears recommendable for restoration of noncarious cervical lesions with composite.
Introduction Current home sleep test (HST) devices are limited by an absence of EEG, or by being too cumbersome to use. We developed a wireless PSG system (Onera Health, NL) consisting of four disposable patches to record EEG, EOG, EMG, SaO2, ECG, bioimpedance derived respiratory airflow and effort, airflow via nasal cannula, snoring sounds, body position, actigraphy, and leg movements. Signals are stored on reusable electronic modules attached to each patch.