Validation Study of Airgo, an Innovative Device to Screen Sleep Respiratory Disorders.

Background: Obstructive sleep apnea affects a consistent percentage of the population, and only a minority of patients have been diagnosed and treated because of a discrepancy between resources available for diagnosis and the epidemiology of a disorder possibly affecting nearly one billion people in the world. Aim: We conducted a study to compare a standard home respiratory monitoring system (Nox T3) with a novel device (Airgo™) consisting of an elastic band and a small recorder, light, comfortable for the patient, and low-cost complete with automatic analysis of the data that produces a screening report indicating the type and severity of sleep respiratory disorder. Patients and Results: We examined 120 patients, reduced to 118 for technical problems. The mean (SD) age of the patients is 55.7 ± 13 years, their BMI is 27.8 ± 4.3 kg/m2, and their AHI is 22 ± 22 events/h. Patients belong to all the different severity rates of OSA, with a percentage of them classified as free of respiratory disorders. The Airgo™ showed excellent agreement with the results of the gold standard, reporting high levels of sensitivity, specificity, positive and negative predicted value, and accuracy. Conclusion: Airgo™ is a reliable tool to screen patients with suspected sleep respiratory disorders, well tolerated by the patient based on totally automatic analysis and reporting system, leading to more efficient use of doctor's and clinician's time and resources and extending the opportunity to diagnose more possible candidates for treatment.

Anxiety and depressive symptoms on continuous positive airway pressure: long-term adherence in patients with sleep apnea syndrome.

BACKGROUND: Obstructive sleep apnea (OSA) is often associated to mood disorders and anxiety symptoms that may influence negatively the treatment approach. However, the relationship between anxiety, depression and adherence to treatment is still unclear. We investigate the presence of anxiety and depressive symptoms in newly diagnosed OSA patients and the link between psychological symptoms and acceptance or adherence to CPAP after one year. METHODS: A validated Italian questionnaire for anxiety and depressive symptoms was administered to 249 patients (69F) with a mean age of 57.2±12.2 and a mean AHI of 40.9±21.9 (ev*hr-1). The CPAP use in the first and last night of acclimatization and one year after prescription was 6.4±2.2, 6.9±1.4 and 5.3±2.2 hr, respectively. RESULTS: Anxiety symptoms were reported by 15.6% of patients, depressive symptoms by 6% while 12.5% reported both anxiety and depressive symptoms. Adherence to CPAP in the first night was not adequate in 19.7% of patients with relevant difference between groups: 16.4% in AD-,20.5% in A+,13.3% in D+ and 38.7% in AD+ (χ2=8.6; P=0.03). However, at the end of acclimatization period only 4.4% of patients utilized CPAP<5/h. One-year after prescription the adherence was adequate in 74.7% of patients without difference between groups. A Cox proportional hazard model demonstrated that AHI (OR=0.985, 95% CI: 0.97-0.99; P=0.03) and compliance to CPAP at the first night of use (OR=0.445; 95% CI: 0.246-0.8; P=0.007) are the only predictive factors of long-term compliance. CONCLUSIONS: Presence of anxiety and depressive symptoms should be checked before PAP titration since they may negatively influence the early acclimatization and adherence.

Sleep Breathing Disorders in the COVID-19 Era: Italian Thoracic Society Organizational Models for a Correct Approach to Diagnosis and Treatment.

The attenuation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, at least in Italy, allows a gradual resumption of diagnostic and therapeutic activities for sleep respiratory disorders. The knowledge on this new disorder is growing fast, but our experience is still limited and when a physician cannot rely on evidence-based medicine, the experience of his peers can support the decision-making and operational process of reopening sleep laboratories. The aim of this paper is to focus on the safety of patients and operators accessing hospitals and the practice of diagnosing and treating sleep-related respiratory disorders. The whole process requires a careful plan, starting with a triage preceding the access to the facility, to minimize the risk of infection. Preparation of the medical record can be performed through standard questionnaires administered over the phone or by e-mail, including an assessment of the COVID-19 risk. The home sleep test should include single-patient sensors or easy-to-sanitize material. The use of nasal cannulas is discouraged in view of the risk of the virus colonizing the internal reading chamber, since no filter has been tested and certified to be used extensively for coronavirus due to its small size. The adaptation to positive airway pressure (PAP) treatment can also be performed mainly using telemedicine procedures. In the adaptation session, the mask should be new or correctly sanitized and the PAP device, without a humidifier, should be protected by an antibacterial/antiviral filter, then sanitized and reassigned after at least 4 days since SARS-CoV-2 was detected on some surfaces up to 72 h after. Identification of pressure should preferably be performed by telemedicine. The patient should be informed of the risk of spreading the disease in the family environment through droplets and how to reduce this risk. The follow-up phase can again be performed mainly by telemedicine both for problem solving and the collection of data. Public access to hospital should be minimized and granted to patients only. Constant monitoring of institutional communications will help in implementing the necessary recommendations.

Day and Night Control of COPD and Role of Pharmacotherapy: A Review.

The topic of 24-hour management of COPD is related to day-to-night symptoms management, specific follow-up and patients' adherence to therapy. COPD symptoms strongly vary during day and night, being worse in the night and early morning. This variability is not always adequately considered in the trials. Night-time symptoms are predictive of higher mortality and more frequent exacerbations; therefore, they should be a target of therapy. During night-time, in COPD patients the supine position is responsible for a different thoracic physiology; moreover, during some sleep phases the vagal stimulation determines increased bronchial secretions, increased blood flow in the bronchial circulation (enhancing inflammation) and increased airway resistance (broncho-motor tone). Moreover, in COPD patients the circadian rhythm may be impaired. The role of pharmacotherapy in this regard is still poorly investigated. Symptoms can be grossly differentiated according to the different phenotypes of the disease: wheezing recalls asthma, while dyspnea is strongly related to emphysema (dynamic hyperinflation) or obstructive bronchiolitis (secretions). Those symptoms may be different targets of therapy. In this regard, GOLD recommendations for the first time introduced the concept of phenotype distinction suggesting the use of inhaled corticosteroids (ICS) particularly when an asthmatic pattern or eosiophilic inflammations are present, and hypothesized different approaches to target symptoms (ie, dyspnea) or exacerbations. Pharmacotherapy should be evaluated and possibly directed on the basis of circadian variations, for instance, supporting the use of twice-daily rapid-action bronchodilators and evening dose of ICS. Recommendations on day and night symptoms monitoring strategies and choice of the specific drug according to patient's profile are still not systematically investigated or established. This review is the summary of an advisory board on the topic "24-hour control of COPD and role of pharmacotherapy", held by five pulmonologists, experts in respiratory pathophysiology, pharmacology and sleep medicine.

Exercise capacity and comorbidities in patients with obstructive sleep apnea.

STUDY OBJECTIVES: There are few studies evaluating (1) exercise capacity as assessed by the 6-minute walking distance (6MWD) test in large populations with obstructive sleep apnea (OSA); and (2) correlations with patients' comorbidities. METHODS: This study presents a cluster analysis performed on the data of 1,228 patients. Severity of exercise limitation was defined on the basis of 6MWD. RESULTS: Sixty-one percent showed exercise limitation (29.2% and 31.9% mild and severe exercise limitation, respectively). About 60% and 40% of patients were included in cluster 1 (CL1) and 2 (CL2), respectively. CL1 included younger patients with high prevalence of apneas, desaturations, and hypertension with better exercise tolerance. CL2 included older patients, all with chronic obstructive pulmonary disease (COPD), high prevalence of chronic respiratory failure (CRF), fewer apneas but severe mean desaturation, daytime hypoxemia, more severe exercise limitation, and exercise-induced desaturations. Only CRF and COPD significantly (P < .001) correlated with 6MWD < 85% of predicted value. 6MWD correlated positively with apnea-hypopnea index, oxygen desaturation index, nocturnal pulse oxygen saturation (SpO2), resting arterial oxygen tension, mean SpO2 on exercise, and negatively with age, body mass index, time spent during night with SpO2 < 90%, mean nocturnal desaturation, arterial carbon dioxide tension, and number of comorbidities. Patients without severe comorbidities had higher exercise capacity than those with severe comorbidities, (P < .001). Exercise limitation was significantly worse in OSA severity class I when compared to other classes (P < .001). CONCLUSIONS: A large number of patients with OSA experience exercise limitation. Older age, comorbidities such as COPD and CRF, OSA severity class I, severe mean nocturnal desaturation, and daytime hypoxemia are associated with worse exercise tolerance.

European position paper on drug-induced sleep endoscopy: 2017 Update.

BACKGROUND: The first edition of the European position paper (EPP) on drug-induced sleep endoscopy (DISE) was published in 2014 with the aim to standardise the procedure, to provide an in-depth insight into the main aspects of this technique and to have a basis for future research. Since 2014, new studies have been published concerning new sedative agents or new insights into the pattern/levels of the obstruction depending on the depth of sedation. Therefore, an enlarged group of European experts in the field of sleep breathing disorders (SBD), including the most of the first DISE EPP main authors, has decided to publish an update of the European position paper on DISE, in order to include new evidence and to find a common language useful for reporting the findings of this endoscopic evaluation in adult population affected by SBD. METHODS: The authors have evaluated all the available evidence reported in the literature and have compared experience among various departments in leading European centres in order to provide an update regarding the standardisation of the DISE procedure and an in-depth insight into the main aspects of this technique. RESULTS: After the first European Position Consensus Meeting on DISE and its update, consensus was confirmed for indications, required preliminary examinations, where to perform DISE, technical equipment required, staffing, local anaesthesia, nasal decongestion, other medications, patient positioning, basics and special diagnostic manoeuvres, drugs and observation windows. So far, no consensus could be reached on a scoring and classification system. However, regarding this aim, the idea of an essential classification, such as VOTE with the possibility of its graded implementation of information and descriptions, seems to be the best way to reach a universal consensus on DISE classification at this stage. A common DISE language is mandatory, and attempts to come to a generally accepted system should be pursued.

Phenotyping the pathophysiology of obstructive sleep apnea using polygraphy/polysomnography: a review of the literature.

Continuous positive airway pressure (CPAP) is the first-line treatment for the majority of patients affected by obstructive sleep apnea syndrome (OSA). However, long-term compliance with CPAP therapy may result limited and alternatives to CPAP therapy are required to address the increasing need to provide tailored therapeutic options. Understanding the pathophysiological traits (PTs) of OSA patients [upper airway (UA) anatomical collapsibility, loop gain (LG), arousal threshold (AT), and UA gain (UAG)] lies at the heart of the customized OSA treatment. However, sleep research laboratories capable to phenotype OSA patients are sparse and the diagnostic procedures time-consuming, costly, and requiring significant expertise. The question arises whether the use of routine clinical polysomnography or nocturnal portable multi-channel monitoring (PSG/PM) can provide sufficient information to characterize the above traits. The aim of the present review is to deduce if the information obtainable from the clinical PSG/PM analysis, independently of the scope and context of the original studies, is clinically useful to define qualitatively the PTs of individual OSA patients. In summary, it is possible to identify four patterns using PSG/PM that are consistent with an altered UA collapsibility, three that are consistent with altered LG, two with altered AT, and three consistent with flow limitation/UA muscle response. Furthermore, some PSG/PM indexes and patterns, useful for the suitable management of OSA patient, have been discussed. The delivery of this clinical approach to phenotype pathophysiological traits will allow patients to benefit in a wider range of sleep services by facilitating tailored therapeutic options.

Development and validation of the Maugeri Sleep Quality and Distress Inventory (MaSQuDI-17).

OBJECTIVES: The aim of this study was to develop and validate a questionnaire designed to measure the impact of sleep impairment on emotional distress in patients with various sleep disorders. METHODS: Five experts created an item data-bank pertaining to sleep-related psychological symptoms and somatic perceptions. Fifty patients in two focus groups examined each item for: a) word clarity (indicating any ambiguity of interpretation) and b) appropriateness for the target population. This process permitted to identify 36 appropriate items. Classical Test Theory and Rasch Analysis were used to further refine the questionnaire, yielding the final 17-item set. Concurrent validation of the new scale was tested with the Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and the Anxiety and Depression questionnaires. RESULTS: Starting from the initial item data-bank, a 17-item questionnaire, the Maugeri Sleep Quality and Distress Inventory (MaSQuDI-17), was produced. Parallel Analysis on the MaSQuDI-17 confirmed the presence of a single dimension; exploratory factor analysis showed salient loading for each item, explaining 58.7% of total variance. Item-remainder correlation ranged from 0.72 to 0.39 and Cronbach alpha was 0.896. Rasch analysis revealed satisfactory psychometric properties of the new scale: the rating structure performed according to expectations, model fit was good and no item dependencies emerged. The scale presented good convergent validity and scores significantly distinguished healthy subjects from OSAS or Insomnia or BSD (p < 0.001). CONCLUSIONS: MaSQuDI -17 shows good psychometric qualities, and can be used to assess the impact of sleep disorders such as Insomnia, OSAS, Central Hypersomnia and BSD on emotional stress.

European position paper on drug-induced sedation endoscopy (DISE).

BACKGROUND: Although drug-induced sedation endoscopy (DISE) represents the most widespread diagnostic tool for upper airway endoscopic evaluation of snoring and obstructive sleep apnea hypopnea syndrome (OSAHS), many controversies exist about how to perform the sedation, the indications for DISE, and how to report DISE findings. The present position paper reports on a consensus as proposed by a group of European experts in the field of DISE after discussion during a recent dedicated meeting. METHODS: The authors have evaluated all the available evidence reported in the literature and have compared experience among various departments in leading European centers in order to provide a standardization of the DISE procedure and an in-depth insight in the main aspects of this technique. RESULTS: A proposal of the DISE procedure standardization has been achieved with a general agreement concerning the terminology, indications, contraindications, required preliminary examinations, setting, technical equipment required, staffing, local anesthesia and nasal decongestion, patient positioning, basis and special diagnostic maneuvers, and the applied sedation drugs and observation windows. Otherwise, no consensus has been reached on a scoring and classification system. CONCLUSIONS: Although consensus has been reached on several aspects of the DISE procedure, some topics remain open to future research, such as a better analysis of the importance of positional aspects during DISE and a further comparison of the differences in degree, level and pattern of upper airway collapse observed during DISE versus during natural sleep and awake endoscopy. Finally, a universally accepted scoring and classification system is lacking.

[Sleep apnea, CPAP therapy and work activity]. / Sindrome delle apnee del sonno, terapia con CPAP ed attività lavorativa.

Obstructive Sleep Apnea syndrome (OSAS) is largely prevalent among the general adult population, particularly among obese subjects. Diurnal somnolence is a characteristic feature of OSAS, one that can interfere on daily life of the patients and also on his/her work-related activities. Aim of this study was to evaluate the impact of OSAS, its symptoms and its therapy with Continuous Positive Airway Pressure (CPAP) may have on work-related activities. Fourty-eight subjects were studied, all > 18 years old and in a work-related age (< 65 years for men, < 60 years for women). There were 34 males and 14 females, 38 actively working, 3 unemployed, 7 not actively working. Before diagnosis the Epworth Sleepiness Scale (ESS) was 12 +/- 4, after the use of CPAP it was 4 +/- 4 (p< 0.001), the Apnea Hypopnea Index (AHI) before CPAP use was 44 +/- 24, after CPAP use 4 +/- 4 (p< 0.001). CPAP compliance was very good (mean hours of CPAP/night 5 +/- 2). At yearly follow-up, work activity was confirmed in all patients, as all employed patients were still working. Our data seem to indicate that not only OSAS interferes with working performance, mainly due to OSAS-related diurnal somnolence, but also that appropriate CPAP therapy, reinforced with educational activities and followed after one year, is able to ameliorate OSAS-related symptoms, potential cause of inefficiency an occupational risk at work.

Heart rate variability in normal and pathological sleep.

Sleep is a physiological process involving different biological systems, from molecular to organ level; its integrity is essential for maintaining health and homeostasis in human beings. Although in the past sleep has been considered a state of quiet, experimental and clinical evidences suggest a noteworthy activation of different biological systems during sleep. A key role is played by the autonomic nervous system (ANS), whose modulation regulates cardiovascular functions during sleep onset and different sleep stages. Therefore, an interest on the evaluation of autonomic cardiovascular control in health and disease is growing by means of linear and non-linear heart rate variability (HRV) analyses. The application of classical tools for ANS analysis, such as HRV during physiological sleep, showed that the rapid eye movement (REM) stage is characterized by a likely sympathetic predominance associated with a vagal withdrawal, while the opposite trend is observed during non-REM sleep. More recently, the use of non-linear tools, such as entropy-derived indices, have provided new insight on the cardiac autonomic regulation, revealing for instance changes in the cardiovascular complexity during REM sleep, supporting the hypothesis of a reduced capability of the cardiovascular system to deal with stress challenges. Interestingly, different HRV tools have been applied to characterize autonomic cardiac control in different pathological conditions, from neurological sleep disorders to sleep disordered breathing (SDB). In summary, linear and non-linear analysis of HRV are reliable approaches to assess changes of autonomic cardiac modulation during sleep both in health and diseases. The use of these tools could provide important information of clinical and prognostic relevance.

General characteristics and risk factors of cardiovascular disease among interstate bus drivers.

Workers in the transportation industry are at greater risk of an incorrect diet and sedentary behavior. The aim of our study was to characterize a population of professional bus drivers with regard to clinical and demographic variables, lipid profile, and the presence of cardiovascular risk factors. Data from 659 interstate bus drivers collected retrospectively, including anthropometric characteristics, systolic and diastolic blood pressure, lipid profile, fasting blood glucose, meatoscopy, and audiometry. All participants were male, with a mean age of 41.7 ± 6.9 years, weight of 81.4 ± 3.3 kg, and BMI 27.2 ± 3.3 Kg/m²; the mean abdominal and neck circumferences were 94.4 ± 8.6 cm and 38.9 ± 2.2 cm; 38.2% of the sample was considered hypertensive; mean HDL cholesterol was 47.9 ± 9.5 mg/dL, mean triglyceride level was 146.3 ± 87.9 mg/dL, and fasting glucose was above 100 mg/dL in 249 subjects (39.1%). Drivers exhibited reduced audiometric hearing at 4-8 kHz, being all sensorineural hearing loss. The clinical characterization of a young male population of interstate bus drivers revealed a high frequency of cardiovascular risk factors, as obesity, hypertension, hyperlipidemia, and hyperglycemia, as well as contributing functional characteristics, such as a low-intensity activity, sedentary behavior, long duration in a sitting position, and high-calorie diet, which lead to excessive weight gain and associated comorbidities.