Validation of the Sleepiz One + as a radar-based sensor for contactless diagnosis of sleep apnea.

PURPOSE: The cardiorespiratory polysomnography (PSG) is an expensive and limited resource. The Sleepiz One + is a novel radar-based contactless monitoring device that can be used e.g. for longitudinal detection of nocturnal respiratory events. The present study aimed to compare the performance of the Sleepiz One + device to the PSG regarding the accuracy of apnea-hypopnea index (AHI). METHODS: From January to December 2021, a total of 141 adult volunteers who were either suspected of having sleep apnea or who were healthy sleepers took part in a sleep study. This examination served to validate the Sleepiz One + device in the presence and absence of additional SpO2 information. The AHI determined by the Sleepiz One + monitor was estimated automatically and compared with the AHI derived from manual PSG scoring. RESULTS: The correlation between the Sleepiz-AHI and the PSG-AHI with and without additional SpO2 measurement was rp = 0.94 and rp = 0,87, respectively. In general, the Bland-Altman plots showed good agreement between the two methods of AHI measurement, though their deviations became larger with increasing sleep-disordered breathing. Sensitivity and specificity for recordings without additional SpO2 was 85% and 88%, respectively. Adding a SpO2 sensor increased the sensitivity to 88% and the specificity to 98%. CONCLUSION: The Sleepiz One + device is a valid diagnostic tool for patients with moderate to severe OSA. It can also be easily used in the home environment and is therefore beneficial for e.g. immobile and infectious patients. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION FOR PROSPECTIVELY REGISTERED TRIALS: This study was registered on clinicaltrials.gov (NCT04670848) on 2020-12-09.

Effect of Triple Combination CFTR Modulator Therapy on Sleep in Adult Patients with Cystic Fibrosis.

BACKGROUND: Sleep-disordered breathing (SDB) and disturbed sleep are common, often underrecognized, comorbidities in people with cystic fibrosis (pwCF). OBJECTIVES: We studied the effect of CFTR triple combination therapy elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on sleep in pwCF. METHOD: This was a prospective, observational sleep study in clinically stable adult pwCF. All participants underwent overnight polysomnography (PSG), before (T0) and after (T1) initiation of CFTR modulator therapy with ELX/TEZ/IVA. In addition, pulmonary function tests, calculation of BMI, and sweat chloride testing were performed. RESULTS: Twenty-nine pwCF (mean age 32 ± 8 years; 15 female) participated in the study. Mean time between T0 and T1 was 194 ± 21 days. Total sleep time (TST) was 298 ± 40 min, with decreased sleep efficiency (SE) (76 ± 109) and increased sleep latency (SL) (73 ± 38 min). Sleep stages for NREM (N1-3) and REM sleep were within the normal range. Nocturnal respiratory events mainly occur during REM sleep (T0: AHI REM 8.3 ± 9.0/h; ODI REM 9.4 ± 10.6/h), whereas the overall AHI was normal (3.6 ± 3.7/h). After initiation of ELX/TEZ/IVA, we saw significant improvements in ppFEV1 (p < 0.001) and BMI (p < 0.001) and a reduction in sweat chloride levels (p < 0.001). In parallel, there was a reduction in AHI (p = 0.003), ODI (p = 0.001), and nocturnal respiratory rate (p < 0.001), both in total, REM and NREM sleep. Neither TST, SL, SE, nor sleep architecture was influenced (all p > 0.05). CONCLUSIONS: Initiation of ELX/TEZ/IVA resulted in significant improvements in SDB in adult pwCF.

Patient preferences in obstructive sleep apnea-a discrete choice experiment.

BACKGROUND: Obstructive sleep apnea (OSA) is one of the most common chronic sleep disorders, which can be treated by different interventions. It is known that acceptance and adherence to these therapies is influenced by a variety of factors. However, there is a limited understanding of patient preferences and decision-making in the context of OSA treatment. METHODS: A discrete choice experiment was conducted on patients with OSA recruited from a tertiary sleep center to evaluate preferences for different treatment attributes. Participants received four different choice tasks with three hypothetical treatments, each defined by seven attributes. A random-effects logit model was used to estimate the influence of the different attributes on the choice decisions. Multivariate logistic regression analysis was carried out to evaluate interactions with medical variables. RESULTS: In a cohort of 241 subjects with OSA, preferences for treatment attributes and utilities derived from them differed. Most relevant attributes were Reduction in risk of comorbidities, Improvements of daytime sleepiness, Requirement for surgery, and Occurrence of treatment-related side effects. Demographic or medical variables, such as age, gender, or apnea-hypopnea index, did not influence the choice decision. Multivariate logistic regression revealed significant differences in preferences depending on OSA disease history (p = .025) and presence of OSA symptoms (p = .033). CONCLUSIONS: The study identified preferences for attributes of OSA and their utilities from a patient perspective. Relevant differences of preferences in subgroups of patients with OSA were identified, which may be important to consider in selecting appropriate treatments that lead to high rates of acceptance and adherence.

Obstructive sleep apnea and nocturnal hypoxemia in adult patients with cystic fibrosis.

BACKGROUND: Obstructive sleep apnea (OSA), nocturnal hypoxemia and excessive daytime sleepiness (EDS) are common comorbidities in people with cystic fibrosis (pwCF). Most of the data showing this originates from children and adolescents. The aim of this study was to collect data on sleep parameters, EDS and pulmonary function from a large cohort of adult pwCF. METHODS: Full overnight polysomnography (PSG) was performed. EDS was determined using the Epworth Sleepiness Scale (ESS). Demographic and clinical data (body mass index [BMI], pulmonary function, capillary blood gases) were collected. RESULTS: A total of 52 adult pwCF were included (mean age 30.7 ± 8.0 years, mean percent predicted forced expiratory volume in 1 s [ppFEV1] of 52.1 ± 14.8). Overall AHI was in the normal range (4.5 ± 4.0/h); 21/52 pwCF (40%) had an apnea-hypopnea index > 5/h. Nocturnal hypoxemia was found in 25% of participants and this was associated with ppFEV1 (p = 0.014), awake oxygen saturation (SpO2; p = 0.021) and awake partial pressure of oxygen (pO2; p = 0.003); there were no significant differences in age, lung function and BMI were found for pwCF with versus without OSA (all p > 0.05). Eight pwCF (15%) had an ESS score > 10 (indicating EDS). OSA was best predicted by awake pO2 (area under the curve [AUC] 0.66, p = 0.048), while nocturnal hypoxemia was best predicted by ppFEV1 (AUC 0.74, p = 0.009), awake pO2 (AUC 0.76, p = 0.006) and awake SpO2 (AUC 0.71; p = 0.025). CONCLUSION: OSA, nocturnal hypoxemia and EDS were common in adult pwCF, but no strong predictors were identified. Therefore, we suggest regular PSG and ESS scoring in adult pwCF, regardless of disease severity.

Adherence Monitoring Using Telemonitoring Techniques.

Telemonitoring is a frequently used tool in the long-term management of many chronic diseases, such as chronic obstructive pulmonary disease or chronic heart failure. The use of new sensors and telemedical tools will shape medical practice in the future, particularly in sleep medicine. During the last decades, the number of people with sleep disordered breathing has been increasing.Telemedicine (TM) approaches could be used in various ways in sleep medicine: telediagnostics, teleconsultation, teletherapy, and telemonitoring of patients being treated with positive pressure devices.This chapter aims to summarize the recent scientific progresses of these techniques as well as their potential clinical applications and tries to give consideration to the remaining problems with TM applications.

A novel minimal-contact biomotion method for long-term respiratory rate monitoring.

PURPOSE: In this study, we assessed the diagnostic accuracy of the device VitaLog (SWG Sportwerk GmbH & Co. KG, Dortmund, Germany) for estimation of respiratory rate (RR) variability. METHODS: VitaLog is a minimal-contact biomotion device that is placed under the mattress topper. It senses respiratory effort and body movement using a piezoelectric sensor. Diagnostic accuracy was determined in 103 patients referred to our sleep laboratory for suspected sleep-disordered breathing (SDB). SDB was defined by AHI ≥ 15/h. Results provided by VitaLog were compared with nasal flow measurement obtained by polysomnography (PSG). RESULTS: Diagnostic accuracy of VitaLog was excellent. We obtained a correlation of r = 0.99 and a bias of 0.2 cycles per minute (cpm) between VitaLog and PSG-provided nasal flow. Detection RR variability worked nearly identically in patients with and without SDB. CONCLUSION: VitaLog is an appropriate method for determination of RR variability based on a minimal-contact biomotion sensor. This device is easy to handle, available at low cost, and suitable for long-term monitoring in the hospital or at home.

Association between habitual physical activity (HPA) and sleep quality in patients with cystic fibrosis.

PURPOSE: Sleep disturbances and poor sleep quality are known to be present in patients with CF. Regular physical activity plays an important role in the treatment of CF patients due to its positive influence on progression of disease and quality of life. The aim of this work is to create a home-based sleep and activity profile and to investigate the influence of habitual physical activity (HPA) on sleep quality in children, adolescents, and adults with CF. METHODS: A total of 109 CF patients (64 male, mean age 22.7 ± 12.0 years; mean ppFEV1 63.0 ± 26.7) were equipped with an actigraph for a home-based collection of data on sleep and activity over 4 weeks. RESULTS: Age, FEV1, and BMI affect sleep and activity in CF patients. Especially younger age and higher FEV1 show a great influence on certain aspects of sleep (SE, TST, TIB, WASO, # of awakenings) and activity and its different intensities. General HPA does not affect sleep, but there is a strong correlation between times spent in vigorous to very vigorous intensities and better sleep quality. CONCLUSION: Besides younger age and higher FEV1, daily activity in higher intensities influences sleeping behavior of CF patients in a positive way. Patients with poor sleep quality and sleep disturbances possibly benefit from an intensification of physical activity in the home environment. TRAIL REGISTRATION: number: 14-6117-BO (University Duisburg-Essen) and NCT03518697 (clinical trials).

Proof of principle study: diagnostic accuracy of a novel algorithm for the estimation of sleep stages and disease severity in patients with sleep-disordered breathing based on actigraphy and respiratory inductance plethysmography.

PURPOSE: In this proof of principle study, we evaluated the diagnostic accuracy of the novel Nox BodySleepTM 1.0 algorithm (Nox Medical, Iceland) for the estimation of disease severity and sleep stages based on features extracted from actigraphy and respiratory inductance plethysmography (RIP) belts. Validation was performed against in-lab polysomnography (PSG) in patients with sleep-disordered breathing (SDB). METHODS: Patients received PSG according to AASM. Sleep stages were manually scored using the AASM criteria and the recording was evaluated by the novel algorithm. The results were analyzed by descriptive statistics methods (IBM SPSS Statistics 25.0). RESULTS: We found a strong Pearson correlation (r=0.91) with a bias of 0.2/h for AHI estimation as well as a good correlation (r=0.81) and an overestimation of 14 min for total sleep time (TST). Sleep efficiency (SE) was also valued with a good Pearson correlation (r=0.73) and an overestimation of 2.1%. Wake epochs were estimated with a sensitivity of 0.65 and a specificity of 0.59 while REM and non-REM (NREM) phases were evaluated a sensitivity of 0.72 and 0.74, respectively. Specificity was 0.74 for NREM and 0.68 for REM. Additionally, a Cohen's kappa of 0.62 was found for this 3-class classification problem. CONCLUSION: The algorithm shows a moderate diagnostic accuracy for the estimation of sleep. In addition, the algorithm determines the AHI with good agreement with the manual scoring and it shows good diagnostic accuracy in estimating wake-sleep transition. The presented algorithm seems to be an appropriate tool to increase the diagnostic accuracy of portable monitoring. The validated diagnostic algorithm promises a more appropriate and cost-effective method if integrated in out-of-center (OOC) testing of patients with suspicion for SDB.

Validation of a non-contact screening device for the combination of sleep-disordered breathing and periodic limb movements in sleep.

PURPOSE: Recent studies found that the non-contact screening device SleepMinder (ResMed Sensor Technologies, Dublin, Ireland) detects sleep-disordered breathing (SDB) with high diagnostic accuracy in cohorts suspected of this disorder. However, it was reported that in patients with periodic limb movement in sleep (PLMS), this non-contact device overestimates the apnea-hypopnea index (AHI). We aimed to overcome this limitation by introducing the novel sleep disorder index (SDI) which is sum of the AHI and the period limb movement index (PLMI). METHODS: Between January 2011 and December 2013, we studied a mixed cohort of 57 patients (31 OSA, 19 PLMS). The easy-to-use non-contact device emits a very weak electromagnetic radiation and detects body movement by measuring the Doppler effect. We interpreted the device-generated movement index as the SDI and validated the diagnostic accuracy against simultaneous application of the gold-standard polysomnography (PSG). RESULTS: We found that the SDI of the non-contact device correlated well with the sum of AHI and PLMI derived from PSG (r = 0.79, p = 0.01). For PSG-derived SDI cutoff ≥ 15/h, we obtained a sensitivity of 92.2% and a specificity of 95.8%. Positive likelihood ratio was 23.3 and negative likelihood ratio 0.03. CONCLUSIONS: The studied non-contact screening device detects accurately the combination of the sleep disorders SDB and/or PLM. However, further testing is required in order to specify the nature of the underlying sleep disorder. At the current stage of algorithm development, the clinical strength is that the studied non-contact device can be used as a rule-out screening device for SDB and PLM.

Clinical validation of a contactless respiration rate monitor.

Respiratory rate (RR) is an often underestimated and underreported vital sign with tremendous clinical value. As a predictor of cardiopulmonary arrest, chronic obstructive pulmonary disease (COPD) exacerbation or indicator of health state for example in COVID-19 patients, respiratory rate could be especially valuable in remote long-term patient monitoring, which is challenging to implement. Contactless devices for home use aim to overcome these challenges. In this study, the contactless Sleepiz One+ respiration monitor for home use during sleep was validated against the thoracic effort belt. The agreement of instantaneous breathing rate and breathing rate statistics between the Sleepiz One+ device and the thoracic effort belt was initially evaluated during a 20-min sleep window under controlled conditions (no body movement) on a cohort of 19 participants and secondly in a more natural setting (uncontrolled for body movement) during a whole night on a cohort of 139 participants. Excellent agreement was shown for instantaneous breathing rate to be within 3 breaths per minute (Brpm) compared to thoracic effort band with an accuracy of 100% and mean absolute error (MAE) of 0.39 Brpm for the setting controlled for movement, and an accuracy of 99.5% with a MAE of 0.48 Brpm for the whole night measurement, respectively. Excellent agreement was also achieved for the respiratory rate statistics over the whole night with absolute errors of 0.43, 0.39 and 0.67 Brpm for the 10th, 50th and 90th percentiles, respectively. Based on these results we conclude that the Sleepiz One+ can estimate instantaneous respiratory rate and its summary statistics at high accuracy in a clinical setting. Further studies are required to evaluate the performance in the home environment, however, it is expected that the performance is at similar level, as the measurement conditions for the Sleepiz One+ device are better at home than in a clinical setting.

Treatment preferences and willingness to pay in patients with obstructive sleep apnea: relevance of treatment experience.

Background: Patients with obstructive sleep apnea (OSA) most commonly receive positive airway pressure therapy (PAP) as primary treatment, which is highly effective when used consistently. Little is known about the preferences for and relevance of attributes of OSA treatments, especially of non-PAP alternatives. The aim of this study was to evaluate treatment preferences and willingness to pay (WTP) among patients with and without previous experience of OSA therapies. Methods: A discrete choice experiment and a structured survey were applied to patients presenting for overnight polysomnography at a tertiary sleep center. Medical variables were obtained from hospital case records. Results: Over a period of 4 months, 241 subjects were enrolled and answered the questionnaire (61.8% with an existing diagnosis, 38.2% with a new diagnosis). The most preferred treatment among all patients was PAP therapy (51.1%), followed by mandibular advancement devices (18.1%), hypoglossal nerve stimulation (17.2%), and medication (13.7%). Approval for the different treatments varied by gender as well as by OSA therapy experience. The importance of attributes of OSA treatment varied too, with low rates of treatment-related side effects being equally important, independent of the preferred therapy. The most often stated monthly WTP for optimal sleep was €â€¯50, with increasing age leading to lower WTP values. Conclusion: Preferences for OSA therapies vary among patients and patient subgroups. PAP therapy is the most preferred treatment, though non-PAP interventions receive high approval ratings too, particularly in treatment-naïve patients. The importance of treatment attributes varies as well, depending on the choice of preferred treatment.

New Paths in Respiratory Sleep Medicine: Consumer Devices, e-Health, and Digital Health Measurements.

Sleep health and tracking sleep with contemporary wearables have become more popular. Sleep disorders, in particular, sleep-disordered breathing, have a higher prevalence than estimated previously. Many patients with apnea and hypopnea events suffer whereas others do not report complaints or show cardiovascular consequences. Assessment with wearables may support efforts to distinguish which type of apnea is related to aging and which to cardiovascular comorbidities. Innovative methods offer smart solutions for problems that are insufficiently addressed. Telemedical concepts help bring patients to sleep medicine expertise at an early stage. To use these methods clinically, they must be certified as medical devices.

Sleep assessment in cystic fibrosis patients using a minimal-impact biomotion system.

PURPOSE: In our study we aimed to analyze sleep variability and activity in patients with cystic fibrosis (CF) during their hospital stay. METHODS: Forty-three CF patients were recruited and have been divided into two subgroups: exacerbated (n = 18) and non-exacerbated (n = 25). During the course of their hospital stay we used VitaLog, a minimal-impact biomotion device, in order to determine total sleep time (TST), time in bed (TIB), sleep efficiency (SE) and intra patient standard deviation (IPSD) of TST. RESULTS: TST was 5.1 h ± 1.5 h and ranged from 0.6h to 7.9 h.TIB was 17.7 h ± 3.8 h and ranged from 5.6h to 23.9 h. SE was 70.0% ± 17.0% and ranged from 13.6% to 98.5%. TST was higher in non-exacerbated patients (5.3 h ± 1.4 h vs. 4.8 h ± 1.6 h, p = 0.008) whereas TIB was lower in non-exacerbated patients (17.0 h ± 3.7 h vs. 18.5 h ± 3.8 h, p = 0.002). We also found that SE was better in non-exacerbated patients (73.1% ± 14.6% vs. 66.6% ± 18.8%, p = 0.002). Furthermore, we observed that IPSD of TST was higher in exacerbated patients (1.3 h ± 0.5 h vs. 0.9 h ± 0.4 h, p = 0.004). CONCLUSION: In general, in CF patients TST was short and SE poor during the night. Furthermore, in the course of their hospital stay patients showed low activity. In exacerbated patients sleep quality was lower compared to non-exacerbated patients.

A prospective comparison of growth patterns with radiomorphology in 232 lung metastases-basis for patient tailored resection planning?

BACKGROUND: The histologic presence of aggressive local growth of pulmonary metastases is associated with an increased risk for local intrapulmonary recurrence after enucleation or wedge resection. Patient tailored resection planning is possible when morphologic pattern of aggressive growth could be identified based on preoperative CT scans. METHODS: Radiomorphology and microscopic growth characteristics from 232 pulmonary metastases from 87 patients were prospectively compared for the presence or absence of aggressive patterns of local intrapulmonary dissemination. RESULTS: Microscopic aggressive local growth was found: pleural involvement (18.5%), lymphatic invasion (6.9%), vascular invasion (7.3%), interstitial growth (38.4%), micro satellite nodules (24.5%), spread through air spaces (STAS) (13.4%), and a smooth, slightly blurred or irregular surface in 34.1%, 43.1% and 22.8%. The radiologic margin demarcation was smooth in 37.1%, blurred in 27.6% or irregular in 35.3% and spiculae were present in 26.3% of the lesions. The microscopic and radiologic description of the metastasis surface correlated well [correlation coefficient (CC) =0.75, P<0.001]. A smooth surface on CT scan corresponded with a smooth microscopic surface in 72/86 (83.7%) of the lesions. The radiomorphologic feature of an irregular or cloudy surface was highly associated with the presence of at least one aggressive pattern of local dissemination (P<0.001). The presence of spiculae on CT scan was well associated with the presence of aggressive local spread (P<0.001) and the microscopic features corresponding with spiculae were interstitial growth, STAS and L1. CONCLUSIONS: Radiomorphologic characteristics of lung metastases correspond well with the microscopic appearance of the resected lesion. Therefore it seems possible to adjust safety margins based on the radiologic appearance of the metastasis.

Sarcomatoid carcinoma of the lung: a rare histological subtype of non-small cell lung cancer with a poor prognosis even at earlier tumour stages.

Objectives: Pulmonary sarcomatoid carcinoma (PSC) is a rare histological subtype of non-small cell lung cancer and comprises a diagnostically and therapeutically challenging group of tumours. We explored the clinicopathological features and prognostic factors of this tumour. Methods: We conducted a retrospective study of all patients who were treated for PSC in the Department of Thoracic Surgery between May 2005 and December 2014. Primary outcomes of interest were patient survival and prognostic factors. Results: A total of 58 patients were treated for sarcomatoid carcinoma within the described period and 46 patients underwent surgical resection with curative intent. The mean follow-up period was 30 months. Of the operated patients, 21.7% had pathological stage I disease, and 78.3% had more advanced disease. There were 25 carcinosarcomas, 10 pleomorphic carcinomas, 7 spindle cell carcinomas, 3 giant cell carcinomas and 1 pulmonary blastoma. Overall 5-year survival of the operated patients was 28.7%. A total of 28 patients experienced recurrence and died cancer-related. Our analysis revealed that tumour size, gender, histological entity, lymphatic vessel invasion (L1) and vascular invasion (V1) did not influence survival. There was a trend for decreased survival in older patients (>65 years). Conclusions: Surgical treatment can achieve satisfactory results with low perioperative mortality, but the overall prognosis even with multimodality concepts and in earlier tumour stages is worse compared to other types of non-small cell lung cancer.

A Single-Institution Analysis of the Surgical Management of Pulmonary Large Cell Neuroendocrine Carcinomas.

BACKGROUND: Large cell neuroendocrine carcinoma (LCNEC) is an uncommon tumor of the lung and represents approximately 3% of all lung cancers. LCNEC displays biological behaviors resembling those of small cell lung carcinomas and features of high-grade neuroendocrine tumors. LCNEC of the lung are considered aggressive. Reported prognoses are heterogeneous, and the optimum treatment remains undefined. METHODS: We conducted a retrospective study of all patients who were treated for LCNEC in our Department of Thoracic Surgery between May 2005 and December 2013. Primary outcomes of interest were patient survival and prognostic factors. Kaplan-Meier analysis was performed to determine the significant predictors of overall survival. RESULTS: Within the prescribed period, 127 patients were treated for LCNEC, and 125 underwent surgical resection with curative intent. Induction chemotherapy or radiochemotherapy was given to 9 patients, and 63 patients received postoperative chemotherapy. Complete resection was achieved in 99.2%. The overall 1-, 3- and 5-year survival rates were 83.7%, 63.2%, and 53.8% of all patients, and the 5-year survival in patients at stages I, II, and III was 64.5%, 40%, and 29.7%. There was a significant survival difference at 5 years between pT1/2 (58.5%) and pT3 tumors (22.4%; p = 0.043) and for patients with lymphatic involvement (L0 vs L1, p = 0.001; pN1 or pN2 vs pN0, p = 0.04). CONCLUSIONS: Surgical treatment can achieve satisfactory results in early tumor stages, which are comparable with other non-small cell lung cancers, with a low perioperative mortality rate.