Effect of one-shot cognitive behavioral therapy on insomnia and heart rate variability of health care workers at the time of COVID-19 pandemic: a randomized controlled trial.

OBJECTIVES: The emergence of sleep disturbances in response to major stressful events has been previously documented. Heart rate variability (HRV) is an objective marker that provides insight into autonomic nervous system dynamics. The aim of the present study was to examine the preliminary effectiveness of a one-shot session of cognitive behavioral therapy for insomnia (CBT-I) for frontline healthcare providers with acute insomnia. METHODS: This study was conducted from 2020 to 2021 on healthcare workers with insomnia. The healthcare workers were randomly allocated to receive either one-shot cognitive behavioral therapy or routine care. Insomnia severity index (ISI) and heart rate variability were assessed before and 1 month after the interventions. RESULTS: Among 57 patients (n = 31 in the intervention group and n = 26 in the control group), mean (± SD) age of both groups were 34.6 (± 9.5) and 36.6 (± 6.9), respectively. Most participants in both groups were female (81% and 65% in the intervention and control groups, respectively; p-value = 0.10). Insomnia severity index score decreased in the intervention group from 13.3 to 6.7 (p < 0.001). The change before and after the intervention was significant between the two groups for HF-normalized unit (high-frequency power band [0.15-0.40 Hz] in the normalized unit) and LF/HF (the ratio of low frequency to high frequency). HF-normalized unit increased in the intervention group (35.8 ± 21.5 vs. 45.6 ± 19.8 before and after the intervention, respectively), and decreased in the control group (43.9 ± 16.5 vs. 39.8 ± 18.5, before and after the intervention, respectively). CONCLUSION: The findings suggest that a single-shot session of cognitive behavioral therapy for insomnia is effective in managing acute insomnia symptoms in healthcare workers.

Absolute mortality risk assessment of COVID-19 patients: the Khorshid COVID Cohort (KCC) study.

BACKGROUND: Already at hospital admission, clinicians require simple tools to identify hospitalized COVID-19 patients at high risk of mortality. Such tools can significantly improve resource allocation and patient management within hospitals. From the statistical point of view, extended time-to-event models are required to account for competing risks (discharge from hospital) and censoring so that active cases can also contribute to the analysis. METHODS: We used the hospital-based open Khorshid COVID Cohort (KCC) study with 630 COVID-19 patients from Isfahan, Iran. Competing risk methods are used to develop a death risk chart based on the following variables, which can simply be measured at hospital admission: sex, age, hypertension, oxygen saturation, and Charlson Comorbidity Index. The area under the receiver operator curve was used to assess accuracy concerning discrimination between patients discharged alive and dead. RESULTS: Cause-specific hazard regression models show that these baseline variables are associated with both death, and discharge hazards. The risk chart reflects the combined results of the two cause-specific hazard regression models. The proposed risk assessment method had a very good accuracy (AUC = 0.872 [CI 95%: 0.835-0.910]). CONCLUSIONS: This study aims to improve and validate a personalized mortality risk calculator based on hospitalized COVID-19 patients. The risk assessment of patient mortality provides physicians with additional guidance for making tough decisions.

Healthcare workers' sleep and mood disturbances during COVID-19 outbreak in an Iranian referral center.

PURPOSE: This study aimed to assess the frequency of sleep and mood disturbances, and their association with COVID-like symptoms in healthcare workers (HCWs) with and without positive Coronavirus RT-PCR in a corona referral center. METHODS: This study was a cross-sectional, anonymous survey of adult HCWs. Data collection was performed in May and June 2020, while governmental restrictions were in place. The participants completed the forms including six separate parts: personal and occupational information, Insomnia Severity Index (ISI), Generalized Anxiety Disorder-7 (GAD-7), Patient's Health Questionnaire (PHQ-9), Pittsburgh Sleep Quality Index (PSQI), and COVID-like symptoms and Coronavirus RT-PCR status. RESULTS: Among the 372 HCW participants, 245 (66%) were women and  mean age was 34.5 ± 7.1 years (age range 23 to 58). The mean scores of all questionnaires except ISI were significantly higher in the HCWs with positive Coronavirus RT-PCR than another group (PSQI, 9 ± 3.4 vs. 6.9 ± 3.1; GAD-7, 9.8 ± 3.6 vs. 7.9 ± 5.3; PHQ-9, 12.8 ± 6.1 vs. 9.5 ± 6.4, P < 0.05; and ISI, 13.8 ± 5.3 vs. 12.3 ± 6 P = 0.163). Positive association between COVID-like symptoms and sleep and mood disturbances was found in the group without a positive test result. Analysis of questionnaires showed higher scores in the group directly involved except for ISI (P < 0.001 and P = 0.053 respectively). CONCLUSIONS: During the COVID-19 pandemic, the HCWs in this sample experienced a high rate of sleep and mood disturbances. There was also a strong association between sleep and mood disturbances and COVID-like symptoms in the group without a positive RT-PCR result. With all this considered, effective psychological support for HCWs during crisis seems to be necessary.

Association of lymphocyte subsets with mortality in severe COVID-19 pneumonia patients.

BACKGROUND: Few studies have investigated the alterations in the T and B cell counts and related subgroups in pulmonary infections especially COVID-19. Here, we aimed to evaluate total T and B lymphocytes and T cell subgroup counts to find the possible correlation between number of these cells and severity and mortality in COVID-19 patients. METHODS: This study was performed on 40 patients with severe COVID-19 infection confirmed by reverse transcription-polymerase chain reaction (RT-PCR) and chest HRCT in August 2020. By the time of admission, T lymphocytes profile in peripheral blood was investigated using multicolor flow cytometry. The total number of T lymphocytes, CD4+ T cells, CD8+ T cells, and B lymphocytes were calculated. Expression of CD2, CD3, CD5, and CD7 as pan T cell surface markers and expression of CD38 and HLA-DR as activated markers on T lymphocytes were also evaluated. RESULTS: Nine patients (22.5%) died during the study and 16 patients (40%) were admitted to ICU. Deceased patients demonstrated lower amounts of T cell count and CD4+ T cell count (with a marginal difference (p = 0.07)) compared with survived patients at the time of admission. The chance of mortality was significantly higher for patients with CD7 loss (OR = 14.89). A marginally significant relationship was also indicated between CD4<200/ml and mortality (OR = 8.65), but no other significant relationships were observed between variables and ICU admission. CONCLUSION: Altogether, CD7 loss on T lymphocytes and CD4+ T cell count below 200/ml revealed a significant relationship with mortality. Considering T lymphocytes and T cell subgroup count could have a predictive value for patients suffering from COVID-19.

Hemoperfusion in patients with severe COVID-19 respiratory failure, lifesaving or not?

BACKGROUND: The new coronavirus outbreak quickly filled hospital beds and stunned the world. Intensive care is required for 5% of patients, and the mortality rate for critically ill patients is 49%. The "cytokine storm" is considered as the main cause of pathogenesis for coronavirus disease-19 (COVID-19)-related respiratory failure, hemoperfusion may be a modality for treatment of disease. MATERIALS AND METHODS: Thirty-seven an patients with positive real-time polymerase chain reaction for SARStions2 in an upper respiratory tract sample or typical chest computed tomography lesion were eligible for this case-control study. Patients meeting the criteria for hemoperfusion including clinical and laboratory indices, were evaluated for outcomes such as hospitalization length and mortality. Patients were divided into three groups, i.e., patients who received hemoperfusion without a need for mechanical ventilation (MV), patients who received hemoperfusion before MV, and patients who received hemoperfusion after MV. RESULTS: Among 37 patients with COVID-19 respiratory failure, 32% were female with a mean age of 55.54 (standard deviation 14.1) years. There was no statistically significant difference between the three groups in terms of length of hospital stay and intensive care unit (ICU) stay (P-tayns: 0.593 and 0.243, respectively, confidence interval [CI]: 95%). Heart rate, respiratory rate, PaO2/FIO2, high-sensitivity C-reactive protein, and ferritin significantly improved after the application of hemoperfusion in all groups (P < 0.05, CI: 95%). CONCLUSION: It seems that applying hemoperfusion in the inflammatory phase of the disease, especially before the intubation, reduce the need for MV. However, hemoperfusion does not have any impacts on the duration of hospital and ICU stay.

The prediction of obstructive sleep apnea severity based on anthropometric and Mallampati indices.

BACKGROUND: Obstructive sleep apnea (OSA) is a common health issue with serious complications. Regarding the high cost of the polysomnography (PSG), sensitive and inexpensive screening tools are necessary. The objective of this study was to evaluate the predictive value of anthropometric and Mallampati indices for OSA severity in both genders. MATERIALS AND METHODS: In a cross-sectional study, we evaluated anthropometric data and the Mallampati classification for the patients (n = 205) with age >18 and confirmed OSA in PSG (Apnea-Hypopnea Index [AHI] >5). For predicting the severity of OSA, we applied a decision tree (C5.0) algorithm, with input and target variables considering two models (Model 1: AHI ≥15 with Mallampati >2, age >51 years, and neck circumference [NC] >36 cm and Model 2: AHI ≥30 with condition: gender = female, body mass index (BMI) >35.8, and age >44 years or gender = male, Mallampati ≥2, and abdominal circumference (AC) >112 then AHI ≥30). RESULTS: About 54.1% of the patients were male. Mallampati, age, and NCs are important factors in predicting moderate OSA. The likelihood of moderate OSA severity based on Model 1 was 94.16%. In severe OSA, Mallampati, BMI, age, AC, and gender are more predictive. In Model 2, gender had a significant role. The likelihood of severe OSA based on Model 2 in female patients was 89.98% and in male patients was 90.32%. Comparison of the sensitivity and specificity of both models showed a higher sensitivity of Model 1 (93.5%) and a higher specificity of Model 2 (89.66%). CONCLUSION: For the prediction of moderate and severe OSA, anthropometric and Mallampati indices are important factors.

Compliance with continuous positive airway pressure in Persian patients with obstructive sleep apnea.

BACKGROUND: Obstructive sleep apnea (OSA) is defined by recurrent apnea and hypopnea during sleep. The main treatment of OSA is continuous positive airway pressure (CPAP). Adherence to CPAP is challenging and depends on multiple factors. This study was designed to evaluate the compliance with CPAP in patients with OSA. MATERIALS AND METHODS: This was a prospective observational study including 106 patients with confirmed OSA by a standard polysomnography. We recorded CPAP usage hours after 7 and 90 days by a smart card. We compared the adherence of the patients with respect to body mass index (BMI), gender, smoking status, living area, and education level. RESULTS: Patients in the 18-45 years' age group had higher compliance in mean (standard deviation) daily use of CPAP (0.93 [0.40] h) compared to the other age groups (P < 0.001). Patients with BMI >35 had better compliance (1.13 [0.44]) than the other patients (P < 0.001). Furthermore, nonsmokers and highly educated patients had better compliance compared to the others (P < 0.001). CONCLUSION: Age, BMI, education, and smoking are important factors in adherence to CPAP in patients with OSA.

Association of irritable bowel syndrome and sleep apnea in patients referred to sleep laboratory.

BACKGROUND: Irritable bowel syndrome (IBS) is assumed as one of the most frequent gastrointestinal disorders, which decreases the patient's quality of life. IBS pathogenesis, however, is not clearly defined. It seems that sleep apnea induces or escalates IBS clinical symptoms. This study aims at evaluating of IBS prevalence in patients, who are afflicted or are not afflicted with sleep apnea. MATERIALS AND METHODS: This was a case-control study, which was implemented in a sleep laboratory located in Isfahan, Iran. We recruited 200 patients being more than 15 years from 2014 to 2015. Based on the apnea-hypopnea index (AHI), we recruited 100 patients in each of two groups: negative sleep apnea (NSA) (AHI ≤4) and positive sleep apnea (PSA) (AHI >4). IBS was diagnosed through a Rome III diagnostic questionnaire. RESULTS: Overall, the prevalence of IBS among patients referred to sleep laboratory was 17.6%. Indeed, IBS prevalence in NSA and PSA groups were 8.2% and 27.1%, respectively. Furthermore, odds ratio of IBS in PSA group versus NSA was 3.92 (95% confidence interval = 1.58-9.77, P = 0.003). Our results showed that the prevalence of IBS did not differ significantly between various severity of sleep apnea (P = 0.452). CONCLUSION: This study showed that there was a positive association between sleep apnea and IBS.

Relationship between obstructive sleep apnea and 30-day mortality among patients with pulmonary embolism.

BACKGROUND: Pulmonary embolism (PE) is the most life-threatening form of venous thrombosis which causes the majority of mortalities in this category. Obstructive sleep apnea (OSA) has been indicated as one of the risk factors for thromboembolism because of hemostatic alterations. The present study was designed to seek for the relationship between OSA and 30-day mortality of patients with PE. MATERIALS AND METHODS: This prospective cohort study was conducted among 137 consecutive patients referred to hospital with symptoms of PE and preliminary stable hemodynamic. Confirmation of PE was made by multislice computed tomography pulmonary angiography and in the case of contraindication; V/Q lung scan and Doppler sonography were done. A STOP-Bang Questionnaire was used to determine patients with high- and low-risk of OSA. Patients were followed up for 1-month, and their survivals were recorded. RESULTS: This study showed that there was no relationship between OSA and 30-day mortality (P = 0.389). Chronic kidney disease (P = 0.004), hypertension (P = 0.003), main thrombus (P = 0.004), and segmental thrombus (P = 0.022) were associated with 30-day mortality. In the logistic regression analysis, history of chronic kidney disease was diagnosed as a risk factor for 30-day mortality among the PE patients (P = 0.029, odds ratio = 4.93). CONCLUSION: Results of this study showed 30-day mortality was not affected by OSA directly. In fact, it was affected by complications of OSA such as hypertension and thrombus. Also, positive history of chronic kidney disease increased the risk of 30-day mortality.

Pulmonary function tests and impulse oscillometry in severe chronic obstructive pulmonary disease patients' offspring.

BACKGROUND: Several studies have showed an increased prevalence of airflow obstruction in first degree relatives of individuals with chronic obstructive pulmonary disease (COPD). Considering no specific research had evaluated airway resistance in offspring of patients with severe COPD, we utilized a spirometry and a impulse oscillometry (IO) to evaluate this population. MATERIALS AND METHODS: In this case control study, from November 2011 to July 2012, we consecutively evaluated 54 offsprings of severe COPD patients (case group) admitted in the pulmonary ward, affiliated to the Isfahan University of Medical Sciences and control group. Pulmonary function tests and the IO were obtained for both groups. Student's t-test was used for inter-group comparisons, and P values below 0.05 were taken as significant. RESULTS: Abnormal increased airway resistance was seen in cases in comparison with controls (R5 Hz [46.29%, P = 0.01], R25 Hz [42.59%, P < 0.001]). Also, considering the spirometry, case group had pulmonary function parameters less than control group (forced vital capacity [FVC]; P = 0.02, forced expiratory volume in 1(st) s; P < 0.001, forced expiratory flow (FEF) 25-75; P < 0.001, FEF 25-75/FVC; P < 0.001) but they were in normal range. CONCLUSION: This study demonstrated increased airway resistance among the severe COPD offsprings. The IO may be a sensitive tool for detection of high risk subjects in families with COPD.

Relationship between craniofacial photographic analysis and severity of obstructive sleep apnea/hypopnea syndrome in Iranian patients.

BACKGROUND: Considering the effectiveness of craniofacial photographic analysis for diagnosis and management of obstructive sleep apnea-hypopnea syndrome (OSAHS) as well as ethnic differences in indexes measured by this method, this study designed to compare the surface facial dimensions, including nose width, intercanthal width and mandibular width of Iranian patients with mild, moderate and severe OSAHS. MATERIALS AND METHODS: In this cross sectional study subjects with mild, moderate and severe OSAHS based on apnea-hypopnea index, were studied. To determine cephalometric measurements, face and neck digital photographs were taken from participants following a standardized procedure. Cephalometric measurements including face, intercanthal and mandibular widths were compared between studied groups. RESULTS: In this study, 100 participants enrolled. From which 20 (20.8%), 35 (36.45%) and 41 (42.7%) of them had mild, moderate and severe OSAHS, respectively. Mean of nose, intercanthal and mandibular width were significantly higher in patients with severe OSAHS than those with mild or moderate OSAHS (P < 0.05). In both genders, mandibular width were higher in severe forms of OSAHS. Disease severity was significantly associated with increased age and mandibular width (P < 0.05). CONCLUSION: Mandibular width was the most important index, which had a significant association with the disease severity. It seems that our results could be used both for diagnosis and follow-up of OSAHS management. They could be used as baseline information as well as a clinical and research tool in the field of OSAHS.

P wave duration and dispersion in Holter electrocardiography of patients with obstructive sleep apnea.

PURPOSE: The underlying mechanisms of the association between obstructive sleep apnea (OSA) and atrial fibrillation (AF) remained unclear. We investigated P wave parameters as indicators of atrial conduction status among OSA patients. METHODS: We studied 42 untreated OSA patients, categorized into mild (6), moderate (18), and severe (18) OSA based on the apnea/hypopnea index (AHI) and 18 healthy controls. Twenty-four-hour Holter electrocardiography was applied to measure P wave parameters including P wave duration and P wave dispersion; difference between the maximum (P-max) and minimum (P-min) measured P wave duration. RESULTS: Mean P wave duration ranged from 110.2 ± 9.3 ms in mild OSA patients to 121.1 ± 15.4 ms in severe OSA patients and was 113.4 ± 10.0 ms in controls with no significant difference among the groups, P = 0.281. P wave dispersion and P-max were significantly longer in those with moderate OSA (68.0 ± 9.3 and 154.2 ± 9.3 ms) and those with severe OSA (71.6 ± 13.7 and 157.2 ± 13.3 ms) than controls (52.6 ± 15.3 and 142.1 ± 15.4 ms), P < 0.05. AHI was significantly correlated with P-max (r = 0.407, P = 0.012) and P wave dispersion (r = 0.431, P = 0.008). With linear regression analysis controlling for age, gender, and BMI, the AHI was independently associated with P wave dispersion (ß = 0.482, P = 0.002). CONCLUSIONS: Using Holter monitoring for measurement of P wave parameters, this study showed an association of OSA with prolonged P-max and P wave dispersion. These results indicate that patients with OSA have disturbances in atrial conduction associated with OSA severity. Repeating this study in a larger sample of patients is warranted.

Pulmonary function tests in ulcerative colitis.

BACKGROUND: Pulmonary impairment in patients suffering ulcerative colitis (UC) has been suggested by several investigators using standard pulmonary function tests (PFTs). This changes in pulmonary function associated with minimal respiratory symptoms have been documented, especially in patients with active disease. The aim of this prospective study was to determine airway resistance and lung volumes in patients with UC who have no respiratory symptoms in comparisons to a healthy control group. MATERIALS AND METHODS: We evaluated a total of 30 patients with UC by means of spirometry, body plethysmography, and impulse oscillometry. The patients were not complaining of any pulmonary symptoms and did not present any history of previous respiratory diseases. As controls we examined 30 healthy subjects matched for gender, age, and smoking status. The relationship between PFT, lung volume, and airway resistance; and the activity, localization, and duration of the UC disease were analyzed. RESULTS: There was a significant difference between airway resistances (kPa/L/s) measured by body plethysmography in patients with UC and those of the controls (R5hz; 0.60 ± 0.44 vs. 0.39 ± 0.13; P < 0.001) and R20hz (0.37 ± 0.19 vs. 0.29 ± 0.1, P = 0.02). There were no correlation between PFT, airway resistance and site and scoring activity (P > 0.05). CONCLUSION: Despite the lack of pulmonary symptoms, increased airway resistance was found in UC patients. We also have not found correlation between PFT, lung volume and airway resistance values and scoring of UC activity.

Mapping the landscape of sleep medicine training across Asia.

STUDY OBJECTIVES: This study assessed the current state of sleep medicine accreditation and training in Asia by conducting a comprehensive survey across 29 Asian countries and regions facilitated by the Asian Society of Sleep Medicine (ASSM) to identify existing gaps and provide recommendations for future enhancements. METHODS: The ASSM Education Task Force Committee designed a survey to gather data on accreditation, education, and training standards in sleep medicine, including information on challenges in enhancing education in the field. RESULTS: With an 86% (25 countries/regions) response rate, the survey showed that sleep medicine is recognized as an independent specialty in just nine countries/regions (36% of the countries/regions surveyed). Ten countries/regions have established sleep medicine training programs, with Japan and Saudi Arabia offering it as a distinct specialty. Significant disparities in training and accreditation standards were identified, with many countries/regions lacking formalized training and practice guidelines. The survey also revealed that most local sleep societies across Asia support the development of an Asian Sleep Medicine Training Curriculum led by the ASSM. However, several barriers significantly impede the establishment and development of sleep medicine training programs, including the scarcity of trained specialists and technologists and the absence of national accreditation for sleep medicine. CONCLUSIONS: The survey highlights the need for standardized sleep medicine training and accreditation across Asia. Developing an Asian Sleep Medicine Training Curriculum and promoting ASSM accreditation guidelines are key recommendations. Implementing these strategies is essential for advancing sleep medicine as a widely recognized discipline throughout Asia.

Evaluation of sleep quality in faculty members of Isfahan university of medical sciences.

BACKGROUND: Sleep disorders can significantly impair the quality of life and daily functions. Evaluating sleep quality can provide valuable information about working conditions. This study aims to evaluate the sleep quality of faculty members at Isfahan University of Medical Sciences (IUMS). METHODS: This descriptive-analytic study was conducted from 2020 to 2021, involving 106 faculty members from the medical school. A questionnaire collected demographic information, including age, sex, height, weight, body mass index (BMI), level of education, history of faculty membership, major, working hours during the day and night, residency place, and medical history. The Pittsburgh Sleep Quality Index (PSQI) and Symptom Checklist-25 (SCL-25) questionnaire were used to assess participants' sleep quality. Data were compared between clinicians and basic science faculty members. RESULTS: PSQI subtypes were examined among the participants. The total PSQI score was 6.20±3.4. A comparison of PSQI scores and subtypes based on age categories did not show any significant differences (P > 0.05 for all). Clinicians had significantly lower total PSQI scores (P=0.044), sleep latency (P=0.024), sleep disturbances (P=0.012), and daytime dysfunction (P=0.022). Additionally, clinicians had a lower severity of sleep latency (P=0.024), sleep disturbances (P=0.012), and total PSQI score (P=0.044). However, clinicians exhibited a higher intensity of daytime dysfunction (P=0.022). CONCLUSION: Faculty members exhibited a high prevalence of sleep disorders, with the most common disorders being sleep disturbance and high sleep latency. The prevalence of sleep disorders was higher among basic science faculty members compared to clinicians.

Positive Pressure Ventilation Treatment Based on Daytime and Night-time Titration in Patients with Obesity Hypoventilation Syndrome: A Randomized Controlled Trial.

Objectives The aim of the present study was to investigate the improvements of gas exchange and excessive daytime sleepiness in patients with obesity hypoventilation syndrome (OHS) in daytime and night-time split polysomnography (DSPSG and NSPSG). Materials and Methods In the present randomized controlled trial, patients with OHS were enrolled in two DSPSG (51 patients) and NSPSG (50 patients) groups in the Bamdad respiratory and sleep research center in Isfahan, Iran. In both groups, the diagnostic polysomnography (PSG) and titration were conducted in one session according to the guidelines of NSPSG. SpO2, PaCO2, and the Epworth Sleepiness Scale (ESS), were measured initially and 12 weeks after treatment. Furthermore, the PSG parameters and the type of treatments for the two groups were recorded and analyzed. Results A total of 101 OHS patients (age: 62.02 ± 12.4 year old; 61 females [60.4%]) were evaluated. There were no significant differences regarding BMI, gender, and AHI between groups ( p > 0.05). Primary SpO2, PaCO2, and ESS were not significantly different between the two groups. After 12 weeks of treatment by continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP), there were significant improvement of SpO2, PaCO2, and ESS score ( p < 0.001). The amount of change of these variables was not different between groups. Among all variables, only the lower SpO2 and higher PaCO2 were associated with response to BiPAP. Discussion There were no significant differences in the number of changes of SpO2, PaCO2, and ESS by treatment in the DSPSG and NSPSG groups. Therefore, DSPSG may be considered as a valuable alternative method for the diagnosis and titration in OHS patients. Clinical Trials IRCT20170512033930N2.

Favipiravir in the Treatment of Outpatient COVID-19: A Multicenter, Randomized, Triple-Blind, Placebo-Controlled Clinical Trial.

BACKGROUND: Finding effective outpatient treatments to prevent COVID-19 progression and hospitalization is necessary and is helpful in managing limited hospital resources. Repurposing previously existing treatments is highly desirable. In this study, we evaluate the efficacy of Favipiravir in the prevention of hospitalization in symptomatic COVID-19 patients who were not eligible for hospitalization. METHODS: This study was a triple-blind randomized controlled trial conducted between 5 December 2020 and 31 March 2021 in three outpatient centers in Isfahan, Iran. Patients in the intervention group received Favipiravir 1600 mg daily for five days, and the control group received a placebo. Our primary outcome was the proportion of hospitalized participants from day 0 to day 28. The outcome was assessed on days 3, 7, 14, 21, and 28 through phone calls. RESULTS: Seventy-seven patients were randomly allocated to Favipiravir and placebo groups. There was no significant difference between groups considering baseline characteristics. During the study period, 10.5% of patients in the Favipiravir group and 5.1% of patients in the placebo group were hospitalized, but there was no significant difference between them (p-value = 0.3). No adverse event was reported in the treatment group. CONCLUSIONS: Our study shows that Favipiravir did not reduce the hospitalization rate of mild to moderate COVID-19 patients in outpatient settings.

Steroid in the Treatment of Outpatient COVID-19: A Multicenter Randomized Controlled Trial.

Background: Early treatment of COVID-19 patients could reduce hospitalization and death. The effect of corticosteroids in the outpatient setting is still unknown. This study aimed to determine the effect of corticosteroids in the prevention of hospitalization of nonsevere cases. Materials and Methods: This study is a multicenter randomized controlled trial. Seventy five nonsevere COVID-19 patients presented between days 7 and 14 of their symptoms received either prednisolone or placebo. The primary outcome was hospitalization. The study protocol was registered in the Iranian Registry of Clinical Trials on December 2, 2020 (IRCT20171219037964N2). Results: Although the rate of hospitalization in the prednisolone group was higher than the placebo group (10.8% vs. 7.9%, respectively), it was not statistically significant (P value.,6). One patient in each group reported an adverse event and withdrew the medication. Conclusion: Considering the null effect of corticosteroids in the prevention of hospitalization in outpatient settings, it is suggested not to consider corticosteroids for outpatient treatment.

Thalidomide for the Treatment of COVID-19 Pneumonia: A Randomized Controlled Clinical Trial.

Background: Coronavirus disease 2019 has become a public health concern with a high number of fatalities. Thalidomide can target inflammatory mediators and decrease inflammation in SARS-CoV-2. Materials and Methods: An open-label, randomized controlled trial was conducted on patients with compatible lung high-resolution computed tomography scan for COVID-19 pneumonia and moderate involvement. Childbearing-age women were excluded. A total of 20 patients in the control group receiving usual treatment were compared with 26 patients in the case group who in addition to the same regimen also received thalidomide. The primary outcome was time for clinical recovery (TTCR) and intensive-care unit (ICU) admission. Results: From April 25 to August 8, 2020, based on the inclusion criteria, 47 patients were assigned to the study. Patients receiving thalidomide had a mean TTCR of days 5.5 (95% confidence interval [CI], 0.7-10.3), as compared with days 5.3 (95% CI, 1.7-8.9) with control (odds ratio 0.01; 95% CI, -1.58-1.59, P = 0.807). The incidence of ICU admission was 27% in the thalidomide group compared with 20% in the control group (odds ratio 3.89; 95% CI, 0.55-27.4, P = 0.425). The mean length of stay in hospital in both groups was 10 days. Progressive improvement in respiratory rate, fever, and O2 saturation during the study was seen in both groups without a significant difference between the thalidomide and control group (P > 0.05). Conclusion: This study investigated the effects of thalidomide to treat moderate COVID-19 clinical outcomes. The results established that this drug regimen did not add more effect to usual treatment for moderate COVID-19 pneumonia.

Sleep apnea symptoms and accident risk factors in Persian commercial vehicle drivers.

BACKGROUND: Motor vehicle accidents are the second highest cause of mortality in Iran. Sleep apnea symptoms have been associated with increased risk of motor vehicle accidents in other countries. However, we have limited data in Iran. We conducted a study to evaluate sleep apnea symptoms and sleepiness in professional drivers and to assess the predictors of motor vehicle accidents in Iran. METHODS: A questionnaire-based cross-sectional study of drivers was done in Shahrekord, Iran. This study used a self-administered questionnaire that included personal information, the Epworth sleepiness scale (ESS), the Berlin questionnaire, and history of previous automobile accidents. Nine hundred thirty-one male drivers (62% of invited drivers), aged 40.2 ± 10.1 years (mean±SD), were included in the study. The mean number of hours spent driving was 48.9 h/week. The median distance covered weekly was 2,905 km/week. Statistical analysis included logistic models with covariate-adjusted P values of <0.01 s (odds ratios and 95% confidence intervals or limits). Independent accident predictors were sought. RESULT: The professional drivers with car accidents had a higher risk in Berlin questionnaire (P < 0.02), a larger mean neck circumference (P < 0.04), and more witnessed apneas (P < 0.04). There was no significant association between in drivers with car accident and ESS above 10. CONCLUSIONS: In Persian professional drivers, high-risk Berlin questionnaire, larger neck circumference, and a history of witnessed apneas were the most important predictors of motor vehicle accident.