[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04124848":3,"trial-entities:NCT04124848":120,"trial-summary:NCT04124848":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":36,"secondary_outcomes":44,"sex":57,"minimum_age":58,"maximum_age":30,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":68,"locations":71,"central_contacts":101,"overall_officials":105,"references":108,"see_also_links":119},"NCT04124848","19-000033","Obstructive Sleep Apnea Among Somali-Americans","Evaluating the Prevalence and Implications of Obstructive Sleep Apnea Among Somali-Americans: A Translational Research Study","RECRUITING","2031-12-31","2025-09","2025-09-15","2019-10-25","Mayo Clinic","OTHER",false,"The investigators seek to advance the understanding of obstructive sleep apnea as it relates to different ethnic origins as well as sex differences. The investigators will compare Somali patients with known obstructive sleep apnea (OSA) to individuals without OSA, and to individuals of other ethnic\u002Fracial origins to determine the risk factors (genetic and\u002For physiologic) associated with developing cardiovascular diseases. This will help the investigators to understand the unique sleep pathology of individuals of African descent.","Participants can be healthy volunteers or volunteers diagnosed with obstructive sleep apnea. All patients may undergo a sleep study (i.e. hospital or home-based), physical examination, questionnaires, blood and urine samples, ultrasound scan of the heart and brachial artery in the arm, CT scan, DEXA scan, paced breathing test, cardiopulmonary test and chemo-sensitivity test.",[19],"Obstructive Sleep Apnea",[21,22,23,24,25,26,27,28],"Somali-Americans","Sleep Disordered Breathing","Cardiovascular Diseases","Sex and Racial Differences","Respiratory Disorders","Hypertension","Diabetes","Health Disparities","OBSERVATIONAL",null,[],{"count":33,"type":34},600,"ESTIMATED",[],[37,41],{"measure":38,"description":39,"timeFrame":40},"To assess the prevalence of obstructive sleep apnea","Measure the apnea-hypopnea index (AHI) to determine burden of obstructive sleep apnea. Based on the AHI, sleep apnea will be diagnosed if the AHI is ≥5 events\u002Fhour.","10 years",{"measure":42,"description":43,"timeFrame":40},"To determine the severity of obstructive sleep apnea","The severity of OSA is classified based on the AHI as follows: None\u002FMinimal: AHI \\\u003C 5 per hour, Mild: AHI ≥ 5, but \\\u003C 15 per hour, Moderate: AHI ≥ 15, but \\\u003C 30 per hour, Severe: AHI ≥ 30 per hour.",[45,48,51,54],{"measure":46,"description":47,"timeFrame":40},"24 hour mean arterial pressure","Ambulatory measure of blood pressure in mmHg",{"measure":49,"description":50,"timeFrame":40},"Vascular endothelial function","Change in brachial artery diameter in response to hyperemia",{"measure":52,"description":53,"timeFrame":40},"Insulin sensitivity","Oral glucose tolerance testing",{"measure":55,"description":56,"timeFrame":40},"Body composition","Percentage body fat content","ALL","18 Years",true,{"inclusion":61,"exclusion":64,"raw_text":67},[62,63],"Self-identify as Somali, African, Asian, and European descent.","Adult males and females who are older than 18 years of age.",[65,66],"Minors under 18 years or adults over 100 years","Positive pregnancy","Inclusion Criteria:\n\n* Self-identify as Somali, African, Asian, and European descent.\n* Adult males and females who are older than 18 years of age.\n\nExclusion Criteria:\n\n* Minors under 18 years or adults over 100 years\n* Positive pregnancy",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":13,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":98},"Rochester","Minnesota","55905","United States",[78,82,85,88,90,92,94,96],{"name":79,"role":80,"phone":81},"CPL","CONTACT","507-422-3499",{"name":83,"role":84},"Virend Somers, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":86,"role":87},"Erik K. St Louis, MD","SUB_INVESTIGATOR",{"name":89,"role":87},"Meghna P. Mansukhani, MD",{"name":91,"role":87},"C. Anwar A. Chahal, MBChB, PhD",{"name":93,"role":87},"Nasra H. Giama, DNP, RN",{"name":95,"role":87},"Joyce E. Balls-Berry, PhD",{"name":97,"role":87},"Fowsiyo Ahmed, MBBS",{"lat":99,"lon":100},44.02163,-92.4699,[102],{"name":103,"role":80,"phone":81,"email":104},"Somers CPL Lab","CPLSOMALI@mayo.edu",[106],{"name":107,"affiliation":13,"role":84},"Virend Somers, MD",[109,113,116],{"pmid":110,"type":111,"citation":112},"40088388","DERIVED","Greenlund IM, Bock JM, Govindan N, Kantas D, Singh P, Covassin N, Somers VK. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. J Racial Ethn Health Disparities. 2026 Jun;13(3):1961-1966. doi: 10.1007\u002Fs40615-025-02389-7. Epub 2025 Mar 15.",{"pmid":114,"type":111,"citation":115},"39502777","Greenlund I, Bock J, Govindan N, Kantas D, Singh P, Covassin N, Somers V. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. Res Sq [Preprint]. 2024 Oct 21:rs.3.rs-4925722. doi: 10.21203\u002Frs.3.rs-4925722\u002Fv1.",{"pmid":117,"type":111,"citation":118},"39182475","Greenlund IM, Kantas D, Prakash SS, Bock JM, Covassin N, Somers VK. Nocturnal Hemodynamics in Somali Americans: Implications for Cardiovascular Risk. Am J Nephrol. 2024;55(6):629-637. doi: 10.1159\u002F000540987. Epub 2024 Aug 24.",[],{"nct_id":4,"conditions":121,"biomarkers":122},[19],[],{"nct_id":4,"found":59,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an observational study, meaning researchers will observe participants without giving a specific treatment. It aims to enroll 600 participants.","completed","Observational Study of Obstructive Sleep Apnea Among Somali-Americans","This study is looking at obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep. Researchers want to understand how OSA affects people of different ethnic backgrounds, especially Somali-Americans, and if there are differences between men and women. They will compare Somali patients with OSA to those without OSA, and to people of other ethnic groups, to find risk factors (like genes or body functions) that might lead to heart problems. The study aims to understand the unique sleep health of people of African descent. You can join if you are 18 or older and identify as Somali, African, Asian, or European. The study hopes to enroll 600 participants. The main goals are to measure how common OSA is and how severe it is over 10 years.","The study will assess the prevalence and severity of obstructive sleep apnea over 10 years.",131,"You may undergo a sleep study (at home or hospital), physical exam, questionnaires, blood and urine tests, heart and arm artery ultrasounds, CT scan, DEXA scan, paced breathing test, cardiopulmonary test, and chemosensitivity test.","Not stated in the trial record.",[],"v2"]