Obstructive Sleep Apnea Among Somali-Americans (Somali OSA)

Evaluating the Prevalence and Implications of Obstructive Sleep Apnea Among Somali-Americans: A Translational Research Study

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/racial origins to determine the risk factors (genetic and/or physiologic) associated with developing cardiovascular diseases. This will help the investigators to understand the unique sleep pathology of individuals of African descent.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Somers CPL Lab; Phone Number: 507-422-3499; Email: CPLSOMALI@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Virend Somers, MD, PhD
      • Sub-Investigator: Erik K. St Louis, MD
      • Sub-Investigator: Meghna P. Mansukhani, MD
      • Sub-Investigator: C. Anwar A. Chahal, MBChB, PhD
      • Sub-Investigator: Nasra H. Giama, DNP, RN
      • Sub-Investigator: Joyce E. Balls-Berry, PhD
      • Sub-Investigator: Fowsiyo Ahmed, MBBS
      • Contact: CPL; Phone Number: 507-422-3499

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population are individuals who are of Somali descent compared to those of different racial/ethnic origins.

Description

Inclusion Criteria:

• Self-identify as Somali, African, Asian, and European descent.
• Adult males and females who are older than 18 years of age.

Exclusion Criteria:

• Minors under 18 years or adults over 100 years
• Positive pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Somali Descent; Study participants who are of Somali origin.
Non-Somali Descent; Study participants who are not of Somali origin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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/hour.	10 years
To determine the severity of obstructive sleep apnea	The severity of OSA is classified based on the AHI as follows: None/Minimal: AHI < 5 per hour, Mild: AHI ≥ 5, but < 15 per hour, Moderate: AHI ≥ 15, but < 30 per hour, Severe: AHI ≥ 30 per hour.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour mean arterial pressure	Ambulatory measure of blood pressure in mmHg	10 years
Vascular endothelial function	Change in brachial artery diameter in response to hyperemia	10 years
Insulin sensitivity	Oral glucose tolerance testing	10 years
Body composition	Percentage body fat content	10 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Sleep Number Corporation
• Investigators: Principal Investigator: Virend Somers, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Cardiovascular Diseases; Hypertension; Health Disparities; Sleep Disordered Breathing; Respiratory Disorders; Somali-Americans; Sex and Racial Differences
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 19-000033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No