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IRCT20200702047987N1 IRCT 2020-07-08 Esfahan University of Medical Sciences The impact of non-invasive ventilation on Obesity hypoventilation syndrome Investigating the Effect of Non-Invasive Ventilation on Depression in Patients with Obesity Hypoventilation Syndrome 2020-08-20 anticipated 50 Complete https://irct.ir/trial/49401 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2-3 obesity hypoventilation syndrome. Intervention group: Patients are hospitalized for sleep test. Meanwhile, checklists for the Depression Questionnaire will be collected before the non-invasive ventilation and one month after the procedure. Diagnosis of depression in patients during the relevant tests is done using questionnaires and approved by a psychiatrist. Before treatment and also one month after non-invasive ventilation treatment, patients' blood gases are measured by a blood gas test. In the invasive ventilator method, the patient's breathing is supported by the CPAP device, which is connected to the patient by a mask, and helps the patient to breathe effectively. This procedure may be needed first during the patient's sleep at night and eventually with the progression of lung disease during the day. In these patients, there is a gradual improvement in daily performance and good night's sleep, and in many cases even proper weight gain occurs, so the patient gradually comes to the conclusion that he himself tends to use NIV. In this method, the pressure starts from 4 to 6 CmH2O and increases to 10 or even more if needed.. Yes - There is a plan to make this available What will be shared: All data can be shared after people have requested. When: Six months after publishing the results. To whom: Academic researchers Conditions: Scientific uses Where to obtain: Isfahan University of Medical Sciences website How to obtain: Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data. Comments:
public Zohreh Naderi
13th farabi street, Mardavij Ave., Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673178 +98 31 3668 0558 zo698@hotmail.com Esfahan University of Medical Sciences scientific Zohreh Naderi
13th farabi street, Mardavij Ave., Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673178 +98 31 3668 0558 zo698@hotmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Having obesity hypoventilation syndrome Patient' will for non-invasive ventilation Confirmation of patients' depression by a psychiatrist 18 years 85 years Both Death before completing the study Dissatisfaction of the patient to complete the study G47.36 Sleep related hypoventilation in conditions classified elsewhere Treatment - Other Intervention group: Patients are hospitalized for sleep test. Meanwhile, checklists for the Depression Questionnaire will be collected before the non-invasive ventilation and one month after the procedure. Diagnosis of depression in patients during the relevant tests is done using questionnaires and approved by a psychiatrist. Before treatment and also one month after non-invasive ventilation treatment, patients' blood gases are measured by a blood gas test. In the invasive ventilator method, the patient's breathing is supported by the CPAP device, which is connected to the patient by a mask, and helps the patient to breathe effectively. This procedure may be needed first during the patient's sleep at night and eventually with the progression of lung disease during the day. In these patients, there is a gradual improvement in daily performance and good night's sleep, and in many cases even proper weight gain occurs, so the patient gradually comes to the conclusion that he himself tends to use NIV. In this method, the pressure starts from 4 to 6 CmH2O and increases to 10 or even more if needed. The severity of depression. Timepoint: Before and one month after the intervention. Method of measurement: Beck Depression Inventory (BDI-II) and Hads Questionnaire. Esfahan University of Medical Sciences Approved 2020-06-15 Ethics committee of IsfahanUniversity of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan Isfahan Isfehan Iran (Islamic Republic of)