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IRCT20220410054475N1 IRCT 2022-04-13 Tehran University of Medical Sciences Assessment of Treatment Effect on Brain Changes in Obstructive Sleep Apnea Syndrome Using MRI Assessment of Treatment Effect on Brain Structural, Functional and Metabolic Changes in Obstructive Sleep Apnea Syndrome Using Magnetic Resonance Imaging 2022-08-21 anticipated 12 Complete https://irct.ir/trial/62870 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Obstructive Sleep Apnea (OSA). Intervention group: Patients with obstructive sleep apnea syndrome who are treated with CPAP device. Control group: Healthy people (no obstructive sleep apnea syndrome) without intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Dr. Mohammad Ali Oghabian
Dr. Gharib Street
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6690 7518 oghabian@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Mohammad Ali Oghabian
Dr. Gharib Street
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6690 7518 oghabian@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who have been diagnosed with obstructive sleep apnea syndrome after a sleep test. 18 years no limit Both People who have a background of respiratory disease (other than apnea). People with a history of malignancy. People with a history of cardiovascular disease. People with a history of neurological diseases (such as neurodegenerative diseases, epilepsy and head trauma). People who abuse alcohol or drugs or take psychotropic drugs while studying. People who have structural lesions in the brain. People who, in addition to obstructive sleep apnea, also have hypoventilation syndrome. People with metabolic diseases (such as polycythemia). Patients who, after PSG and clinical tests, are diagnosed as not candidates for CPAP treatment. People who have contraindications to MRI scans (such as people with cardiac pacemakers and metal implants or even people with a fear of closed space (Claustrophobia)). G47.33 Obstructive sleep apnea (adult) (pediatric) Treatment - Devices Intervention group: Patients with obstructive sleep apnea syndrome who are treated with CPAP device. Control group: Healthy people (no obstructive sleep apnea syndrome) without intervention Brain Cortical Thickness. Timepoint: Before treatment, 6 months after treatment. Method of measurement: Analysis of structural MR images. Functional connection of brain areas (rsFC). Timepoint: Before treatment, 6 months after treatment. Method of measurement: Analysis of functional MR images. Oxygen Extraction Fraction (OEF). Timepoint: Before treatment, 6 months after treatment. Method of measurement: Analysis of structural MR images. Tehran University of Medical Sciences Approved 2022-02-21 Ethics committee of Tehran University of Medical Sciences (Faculty of Medicine) Poursina Street Tehran Tehran Iran (Islamic Republic of)