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Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION (To be submitted in duplicate) 1. Name of the candidate and address Dr. RIYAZ MOIDEEN, S/O PATHOOR MOIDEEN, MALAPPURAM DISTRICT, KERALA 676309 2. Name of the Institution M.S.RAMAIAH MEDICAL COLLEGE, BANGALORE 3. Course of the study and subject M.D. RESPIRATORY MEDICINE 4. Date of Admission to Course 1st June, 2011 5. Title of topic PREVALENCE OF OBSTRUCTIVE SLEEP APNEA (OSA) IN PATIENTS WITH METABOLIC SYNDROME. 1 6.BRIEF RESUME OF THE INTENDED WORK: 6.1 BACKGROUND: Short sleep duration and poor quality of sleep, increasingly common in our modern society, have many effects on our endocrine and metabolic function. Sleep is a major buffer for hormonal release, glucose regulation and cardiovascular function1. Sleep-disordered breathing (SDB) disrupts sleep pattern and quality. Obstructive sleep apnoea (OSA) is the most common sleep disorder being diagnosed1. It is a chronic condition that is characterized by repetitive upper airway obstructions resulting in intermittent hypoxia and sleep fragmentation caused by arousals 2. Obstructive sleep apnea syndrome has been associated with an increased incidence of hypertension, stroke, and cardiovascular disease 3. Metabolic syndrome (MS) was first described as a cluster of metabolic abnormalities, with insulin resistance as the central pathophysiological feature, and it was labelled as “Syndrome X 1 . It is characterized by hypertension, abdominal obesity, increased triglycerides and blood glucose and decreased HDL cholesterol and is associated with an increased risk for the development of type 2 diabetes mellitus and cardiovascular disease 4. Recently, there has been great interest in the interaction between OSA and metabolic dysfunction. In particular, OSA has been independently associated with insulin resistance, suggesting that OSA may be an important factor for the development of type 2 diabetes and the so called metabolic syndrome (MS) 2. Syndrome Z (SZ) is defined as the co-occurrence of OSA and metabolic syndrome. Though there is circumstantial evidence to implicate OSA in the development of MS, the causal relationship remains unproven. Recent community based study on prevalence of OSA ,MS and syndrome Z in urban population of New Delhi, shows that there is a high prevalence of OSA among the patients with MS 4 . 2 6.2 NEED FOR THE STUDY OSA in patients with metabolic syndrome is an important issue for research as the prevalence of obesity is increasing worldwide and with this prevalence of OSA and MS will also increase tremendously. This would require urgent public health intervention strategies, otherwise health resources of the developing and developed nations will be overburdened 4. OSA or snoring is shown to be independently associated with an increased prevalence of metabolic syndrome, and this is consistent across different ethnic origins. There is a need for further studies to reconfirm results on Indian population and polysomnography must be done in all patients of metabolic syndrome for detection of OSA 4. Early CPAP treatment has produced some beneficial effects on individual metabolic components of MS hence identification and treatment of OSA in patients with MS is essential1. There is clear evidence that sleep apnoea treatment both improves the symptoms of sleep apnoea, particularly excessive daytime sleepiness, and lowers blood pressure. There is some evidence that treatment also reduces cardiovascular disease risk and may sometimes improve diabetes control5. 6.3 REVIEW OF LITERATURE: Sleep apnoea Sleep apnoea is part of the spectrum of disorders characterised by abnormal breathing during sleep, which range from intermittent snoring to persistent snoring, upper airway resistance syndrome, OSA syndrome and obesity hypoventilation syndrome5. OSA may be associated with such symptoms as excessive daytime sleepiness, loud snoring reported by the patient and/or his or her partner, a feeling of choking or suffocation at night, unrefreshing or restless sleep, changes in mood and personality and 3 cognitive changes. These symptoms can be readily detected using simple screening questionnaires such as the Epworth Sleepiness Scale and Berlin questionnaires5. Diagnosis The diagnosis of sleep apnoea can be made using complete nocturnal polysomnography (PSG), which records multiple channels of physiological data (EEG, EMG, EOG, pulse oximetry, air flow, respiratory effort and ECG) . However, sleep specialists are now adopting simpler screening studies that can even be conducted at home; these tests simply measure oxygen saturation, nasal air flow and/or respiratory effort. The purpose of these tests is to evaluate how many episodes of apneas and hypopneas occur through the night 5. The severity of sleep apnoea is defined using the apnoea–hypopnoea index (AHI) or the respiratory disturbance index (RDI), which represent the number of apnoeas and hypopneas per hour of sleep5. Severity of sleep apnoea can be graded as mild sleep apnoea when AHI: 5 to 15 events per hour, moderate sleep apnea when AHI:15 to 30 events per hour, severe sleep apnoea, AHI greater than 30 events per hour6. OSA and MS The past two decades have seen a growing recognition of the presence of various types of metabolic dysfunction in subjects with OSA, and the association of OSA and MS was highlighted as "syndrome Z" in the late 1990s . However, there is paucity of literature linking MS with sleep-disordered breathing. There is growing experimental and clinical evidence for an independent contribution of OSA towards the development and/or severity of individual metabolic components of MS. On the contrary, MS and its components—in particular, obesity and insulin resistance/diabetes mellitus—may have a conducive influence on the development 4 of sleep apnea, and it has been proposed that OSA itself may well be a "metabolic disorder" and a component of MS 2. (Figure I) FIG:1 Possible mechanistic links between obstructive sleep apnea, metabolic syndrome and type 2 diabetes 2. OSA may affect metabolism indirectly, by decreasing the amount and/or quality of sleep. Sleep loss profoundly affects metabolic pathways. In healthy subjects, experimental sleep restriction caused insulin resistance, together with increased evening cortisol and sympathetic activation. Sleep restriction was also shown to be associated with reduced leptin and increased ghrelin plasma concentrations and increased appetite. Modest acute sleep loss, such as selective slow-wave sleep deprivation, may alter glucose tolerance in normal subjects7. A prospective study done in young adults found a significant risk of obesity in subjects reporting short sleep duration, leading to speculation that decreased sleeping time over the recent decades may have contributed to the increasing prevalence of obesity in the 5 general population. In addition, in general population cohorts, difficulties falling asleep, difficulties in sleep maintenance and reduction in sleep duration have been found to be associated with an increased incidence of diabetes 7. Obesity affects upper airway anatomy because of increased fat deposition in the neck region which in turn predisposes to upper airway collapsibility during sleep 1. Prevalence The overall population prevalence of sleep apnoea in adults is between 2 and 4%, with the condition being about twice as common in men 5. The prevalence of OSA among obese patients has been reported to exceed 30 per cent, and 60-90 per cent of adults with OSA are overweight, and the relative risk of sleep apnoea from obesity with a BMI >30 kg/m2 may be as great as 101. Treatment Treatment options for Patients with sleep apnoea are reduction in weight, modest weight loss, can improve symptoms of sleep apnoea. Patients who have specific abnormalities of the palate or jaw may benefit from specific surgery, but the majority of patients will require treatment with nasal continuous positive airway pressure (CPAP) ventilation, which has been shown to improve symptoms of sleep apnoea in a range of studies5. 6.4 AIM OF THE STUDY The aim is to determine the prevalence of Obstructive sleep apnoea in patients diagnosed with metabolic syndrome. 6 6.5 OBJECTIVES OF THE STUDY To evaluate patients with metabolic syndrome for OSA. 7. MATERIALS AND METHODS: Eighty five patients with metabolic syndrome attending M S Ramaiah Hospitals between 2011 and 2014 will be included for the study. The following data will be compiled in all patients. • Clinical history and demographic data. • BMI (wt in kg/ht in m2) • Blood pressure (recorded after at least 5 minutes of rest in both arms sitting/supine position) • Waist circumference (measured in a horizontal plane midway between the inferior margin of the ribs and superior border of the iliac crest) • Blood samples of 5ml will be drawn after 12 hours overnight fasting for the measurement of lipid profile, fasting plasma glucose • Patients fulfilling the IDF criteria for metabolic syndrome will be screened for symptoms of OSA (snoring, witnessed apneas and excessive day time sleepiness). Epworth sleepiness scale will be used to screen for EDS. Physical examination will be performed to look for upper airway anatomy. Patients with suggestive symptoms of OSA and ESS of score more than 10 will undergo a limited polysomnography with three channels which includes nasal airflow measurement, chest movement and pulse oximetry. 7 7.1 DIAGNOSIS OF METABOLIC SYNDROME: According to new IDF criteria for a person to be defined as having the metabolic syndrome they must have 1: Central obesity – defined as waist circumference 90cm for men and 80 cm for women (Indian population). Plus any two of the following four factors 1) Raised TG level 150mg/dl or specific treatment for this lipid abnormality 2) Reduced HDL cholesterol <40mg/dl or specific treatment for this lipid abnormality 3) Raised B.P systolic 130 diastolic 85 or treatment for previously diagnosed hypertension. 4) Raised FBG 100mg/dl or previously diagnosed type 2 diabetes. 7.2 DIAGNOSIS OF OSA OSA is defined as apnoea-hypopnoea index (AHI) > 5 that is more than five episodes per hour of cessation of breathing for at least 10 seconds 3. Apneas were defined by an 80% or greater reduction in the airflow signal with persistent respiratory effort lasting 10 seconds or longer. Hypopneas were defined as a 30% or greater reduction in the airflow signal with persistent respiratory effort lasting at least 10 seconds associated with a desaturation of 4% or greater 3. Severity of sleep apnoea can be graded as mild sleep apnoea when AHI: 5 to 15 events per hour, moderate sleep apnea when AHI:15 to 30 events per hour, severe sleep apnea, AHI greater than 30 events per hour6. 8 7.3 SOURCE OF DATA: Adult patients (Out Patients and In Patients) with signs of metabolic syndrome attending MS Ramaiah Hospitals. 7.3 STUDY DESIGN: A hospital based cross-sectional study. 7.4 INCLUSION CRITERIA: Patients fulfilling IDF criteria for metabolic syndrome. 7.5 EXCLUSION CRITERIA: - Hypothyroidism - Critically ill patients - Patients with end stage organ disease and malignancy - Pregnant women 7.6 SAMPLE SIZE CALCULATION: Sample size was estimated to be approximately a minimum of 85. It was estimated using N-master software considering a population based Indian study showed that frequency of OSA among MS patients is primarily 66% with a relative precision (allowable error) of 10% and confidence interval of 95%. 9 7.7 STATISTICAL ANALYSIS: All the data like age, vital signs and investigations will be presented as mean and standard deviation with 95% confidence intervals. Further differences in the proportions between different groups with various conditions of metabolic syndrome among features with standardizing further for their significance through Chi-square table of significance. An attempt will be made to employ logistic regression to identify the further association of the various components of metabolic syndrome with OSA. 7.8 Does this study require any investigations or interventions to be conducted on patients or other humans or animals? If so, describe briefly. Limited polysomnograpy 7.8 Has ethical clearance been obtained from your institution? 10 8. REFERENCES 1. Jamie C.M. Lam & Mary S.M. Ip. Sleep & the metabolic syndrome. Indian J Med Res 2010; 131(2): 206-16. 2. Esra Tasali and Mary S. M. Ip. Obstructive Sleep Apnea and Metabolic Syndrome Alterations in Glucose Metabolism and Inflammation. Proc Am Thorac Soc 2008; 5: 207–17. 3. Parish JM; Adam T; Facchiano L. Relationship of Metabolic Syndrome and Obstructive Sleep Apnea. J Clin Sleep Med 2007;3(5):467-72. 4. Surendra K. Sharma & Vishnubhatla Sreenivas. Are metabolic syndrome, obstructive sleep apnoea & syndrome Z sequential? - A hypothesis. Indian J Med Res 2010; 131: 455-58 5. John Wilding and John O’Reilly. Sleep Apnoea, Obesity, Diabetes and the Metabolic Syndrome. Eur Endocrine Dis 2007;1: 72-5. 6. Alfred P. Fishman, MD, Jack A. Elias, MD, Jay A. Fishman, MD,Text book of Fishman’s Pulmonary Diseases and Disorders. Fourth Edition, New York: McGraw-Hill; 2008. p.1679-735. 7. P. Lévy Et.al. Sleep, sleep-disordered breathing and metabolic consequences , Eur Respir J 2009 ; 34 : 243-260 11 9. Signature of the candidate : 10. Remarks of the guide : This study is significant as incidence of metabolic syndrome and sleep disordered breathing are noticed increasingly now a days with advent of newer diagnostic tools. 10.1 Name and designation of the guide : DR. K.N.MOHAN RAO.MD,DTCD. Professor and HOD Department of Chest medicine , M.S.R.M.C, Bangalore. 10.2 Signature of the guide : 11. Remarks of the Co-guide: This study will be a valuable addition to the evidence available that links MS to OSA 11.1 Name and designation of the Co-guide : DR. UMA MAHESHWARI.MD, DM. Associate Professor, Department of Chest medicine, M.S.R.M.C, Bangalore. 12 11.2 Signature of the Co-guide : 12. Name and designation of the H.O.D : DR. K.N.MOHAN RAO, Professor and HOD Department of Chest medicine, M.S.R.M.C, Bangalore. 12.1 Signature of the H.O.D : 13. Remarks of the Principal : 13.1 Signature of the Principal: 13 14 15